breast cancer research and treatment impact factor 2023

Breast Cancer Research and Treatment

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Breast Cancer Research and Treatment

Journal Abbreviation: BREAST CANCER RES TR Journal ISSN: 0167-6806

About Breast Cancer Research and Treatment

You may also be interested in the following journals.

• ► Breast Cancer Research
• ► Cancer Research
• ► Cancer Letters
• ► British Journal of Cancer
• ► PLoS One
• ► Cancer Science
• ► Journal of Breast Cancer
• ► Breast Cancer
• ► Molecular Cancer Therapeutics
• ► Clinical Cancer Research

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Journal Impact

Advances in Breast Cancer Research

A polyploid giant cancer cell (PGCC) from triple-negative breast cancer.

NCI-funded researchers are working to advance our understanding of how to prevent, detect, and treat breast cancer. They are also looking at how to address disparities and improve quality of life for survivors of the disease.

This page highlights some of what's new in the latest research for breast cancer, including new clinical advances that may soon translate into improved care, NCI-supported programs that are fueling progress, and research findings from recent studies.

Early Detection of Breast Cancer

Breast cancer is one of a few cancers for which an effective screening  test, mammography , is available. MRI ( magnetic resonance imaging ) and  ultrasound  are also used to detect breast cancer, but not as routine screening tools for people with average risk.

Ongoing studies are looking at ways to enhance current breast cancer screening options. Technological advances in imaging are creating new opportunities for improvements in both screening and early detection.

One technology advance is 3-D mammography , also called breast tomosynthesis . This procedure takes images from different angles around the breast and builds them into a 3-D-like image. Although this technology is increasingly available in the clinic, it isn’t known whether it is better than standard 2-D mammography , for detecting cancer at a less advanced stage.

NCI is funding a large-scale randomized breast screening trial, the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) , to compare the number of advanced cancers detected in women screened for 5 years with 3-D mammography with the number detected in women screened with 2-D mammography. 

Two concerns in breast cancer screening, as in all cancer screening, are:

• the potential for diagnosing tumors that would not have become life-threatening ( overdiagnosis )
• the possibility of receiving false-positive test results, and the anxiety that comes with follow-up tests or procedures

As cancer treatment is becoming more individualized, researchers are looking at ways to personalize breast cancer screening. They are studying screening methods that are appropriate for each woman’s level of risk and limit the possibility of overdiagnosis.

For example, the Women Informed to Screen Depending on Measures of Risk (WISDOM) study aims to determine if risk-based screening—that is, screening at intervals that are based on each woman’s risk as determined by her genetic makeup, family history , and other risk factors—is as safe, effective, and accepted as standard annual screening mammography.

WISDOM is also making a focused effort to enroll Black women in the trial. Past studies  tended to contain a majority of White women and therefore, there is less data on how screening can benefit Black women. Researchers are taking a number of steps to include as many Black women as possible in the study while also increasing the diversity of all women enrolled.

Breast Cancer Treatment

The mainstays of breast cancer treatment are surgery , radiation , chemotherapy , hormone therapy , and targeted therapy . But scientists continue to study novel treatments and drugs, along with new combinations of existing treatments.

It is now known that breast cancer can be divided into subtypes based on whether they:

• are hormone receptor (HR) positive which means they express  estrogen and/or progesterone receptors  ( ER , PR )

Shortening Radiation Therapy for Some with Early Breast Cancer

A condensed course was as effective and safe as the standard course for women with higher-risk early-stage breast cancer who had a lumpectomy.

As we learn more about the subtypes of breast cancer and their behavior, we can use this information to guide treatment decisions. For example:

• The NCI-sponsored TAILORx clinical trial. The study, which included patients with ER-positive, lymph node-negative breast cancer, found that a test that looks at the expression of certain genes can predict which women can safely avoid chemotherapy.
• The RxPONDER trial found that the same gene expression test can also be used to determine treatment options in women with more advanced breast cancer. The study found that some postmenopausal women with HR positive, HER-2 negative breast cancer that has spread to several lymph nodes and has a low risk of recurrence do not benefit from chemotherapy when added to their hormone therapy. 
• The OFSET trial is comparing the addition of chemotherapy to usual treatment ( ovarian function suppression plus hormone therapy) to usual treatment alone in treating premenopausal estrogen receptor (ER)-positive/HER2-negative breast cancer patients who are at high risk of their cancer returning. This will help determine whether or not adding chemotherapy helps prevent the cancer from returning.  

Genomic analyses, such as those carried out through  The Cancer Genome Atlas (TCGA) , have provided more insights into the molecular diversity of breast cancer and eventually could help identify even more breast cancer subtypes. That knowledge, in turn, may lead to the development of therapies that target the genetic alterations that drive those cancer subtypes.

HR-Positive Breast Cancer Treatment 

Hormone therapies have been a mainstay of treatment for HR-positive cancer. However, there is a new focus on adding targeted therapies to hormone therapy for advanced or metastatic HR-positive cancers. These treatments could prolong the time until chemotherapy is needed and ideally, extend survival. Approved drugs include:

Drug Combo Effective for Metastatic Breast Cancer in Younger Women

Ribociclib plus hormone therapy were superior to standard chemotherapy combos in a recent trial.

• Palbociclib (Ibrance) ,  ribociclib (Kisqali) , and  everolimus (Afinitor) have all been approved by the FDA for use with hormone therapy for treatment of advanced or metastatic breast cancer. Ribociclib has been shown to increase the survival of patients with metastatic breast cancer . It has also shown to slow the growth of metastatic cancer in younger women when combined with hormone therapy.
• Elacestrant (Orserdu) is approved for HR-positive and HER2-negative breast cancer that has a mutation in the ESR1 gene, and has spread. It is used in postmenopausal women and in men whose cancer has gotten worse after at least one type of hormone therapy.
• Abemaciclib (Verzenio) can be used with or after hormone therapy to treat advanced or metastatic HR-positive, HER2-negative breast cancer. In October 2021, the Food and Drug Administration ( FDA ) approved abemaciclib in combination with hormone therapy to treat some people who have had surgery for early-stage HR-positive, HER2-negative breast cancer.
• Alpelisib (Piqray)  is approved to be used in combination with hormone therapy to treat advanced or metastatic HR-positive, HER2-negative breast cancers that have a mutation in the PIK3CA gene .
• Sacituzumab govitecan-hziy (Trodelvy) is used for HR-positive and HER2-negative breast cancer that has spread or can't be removed with surgery. It is used in those who have received hormone therapy and at least two previous treatments. It has shown to extend the amount of time that the disease doesn't get worse ( progression-free survival ) and also shown to improve overall survival .

HER2-Positive Breast Cancer Treatment 

The FDA has approved a number of targeted therapies to treat HER2-positive breast cancer , including:

• Trastuzumab (Herceptin) has been approved to be used to prevent a relapse in patients with early-stage HER2-positive breast cancer. 
• Pertuzumab (Perjeta) is used to treat metastatic HER2-positive breast cancer, and also both before surgery ( neoadjuvant ) and after surgery ( adjuvant therapy ). 
• Trastuzumab and pertuzumab together can be used in combination with chemotherapy to prevent relapse in people with early-stage HER2-positive breast cancer.  Both are also used together in metastatic disease, where they delay progression and improve overall survival. 
• Trastuzumab deruxtecan (Enhertu) is approved for patients with advanced or metastatic HER2-positive breast cancer who have previously received a HER2-targeted treatment. A 2021 clinical trial showed that the drug lengthened the time that people with metastatic HER2-positive breast cancer lived without their cancer progressing. The trial also showed that it was better at shrinking tumors than another targeted drug, trastuzumab emtansine (Kadcyla).
• Tucatinib (Tukysa) is approved to be used in combination with trastuzumab and capecitabine (Xeloda) for HER2-positive breast cancer that cannot be removed with surgery or is metastatic. Tucatinib is able to cross the blood–brain barrier, which makes it especially useful for HER2-positive metastatic breast cancer, which tends to spread to the brain. 
• Lapatinib (Tykerb)  has been approved for treatment of some patients with HER2-positive advanced or metastatic breast cancer, together with capecitabine or letrozole.
• Neratinib Maleate (Nerlynx) can be used in patients with early-stage HER2-positive breast cancer and can also be used together with capecitabine (Xeloda) in some patients with advanced or metastatic disease.
• Ado-trastuzumab emtansine (Kadcyla) is approved to treat patients with metastatic HER2-positive breast cancer who have previously received trastuzumab and a taxane . It's also used in some patients with early-stage HER2-positive breast cancer who have completed therapy before surgery ( neoadjuvant ) and have residual disease at the time of surgery.

HER2-Low Breast Cancer

 A newly defined subtype, HER2-low, accounts for more than half of all metastatic breast cancers. HER2-low tumors are defined as those whose cells contain lower levels of the HER2 protein on their surface. Such tumors have traditionally been classified as HER2-negative because they did not respond to drugs that target HER2. 

However, in a clinical trial, trastuzumab deruxtecan (Enhertu) improved the survival of patients with HER2-low breast cancer compared with chemotherapy , and the drug is approved for use in such patients. 

Immunotherapy Improves Survival in Triple-Negative Breast Cancer

For patients whose tumors had high PD-L1 levels, pembrolizumab with chemo helped them live longer.

Triple-Negative Breast Cancer Treatment 

Triple-negative breast cancers (TNBC) are the hardest to treat because they lack both hormone receptors and HER2 overexpression , so they do not respond to therapies directed at these targets. Therefore, chemotherapy is the mainstay for treatment of TNBC. However, new treatments are starting to become available. These include:

• Sacituzumab govitecan-hziy (Trodelvy)  is approved to treat patients with TNBC that has spread to other parts of the body . Patients must have received at least two prior therapies before receiving the drug.
• Pembrolizumab (Keytruda)  is an immunotherapy drug that is approved to be used in combination with chemotherapy for patients with locally advanced or metastatic TNBC that has the PD-L1 protein. It may also be used before surgery (called neoadjuvant ) for patients with early-stage TNBC, regardless of their PD-L1 status.
• PARP inhibitors, which include olaparib (Lynparza) and talazoparib (Talzenna) , are approved to treat metastatic HER2-negative or triple-negative breast cancers in patients who have inherited a harmful BRCA gene mutation. Olaparib is also approved for use in certain patients with early-stage HER2-negative or triple-negative breast cancer. 
• Drugs that block the androgen receptors  or prevent androgen production are being tested in a subset of TNBC that express the androgen receptor.

For a complete list of drugs for breast cancer, see Drugs Approved for Breast Cancer .

NCI-Supported Breast Cancer Research Programs

Many NCI-funded researchers working at the NIH campus, as well as across the United States and world, are seeking ways to address breast cancer more effectively. Some research is basic, exploring questions as diverse as the biological underpinnings of cancer and the social factors that affect cancer risk. And some are more clinical, seeking to translate this basic information into improving patient outcomes. The programs listed below are a small sampling of NCI’s research efforts in breast cancer.

TMIST is a randomized breast screening trial that compares two Food and Drug Administration (FDA)-approved types of digital mammography, standard digital mammography (2-D) with a newer technology called tomosynthesis mammography (3-D).

The  Breast Specialized Programs of Research Excellence (Breast SPOREs)  are designed to quickly move basic scientific findings into clinical settings. The Breast SPOREs support the development of new therapies and technologies, and studies to better understand tumor resistance, diagnosis, prognosis, screening, prevention, and treatment of breast cancer.

The NCI Cancer Intervention and Surveillance Modeling Network (CISNET) focuses on using modeling to improve our understanding of how prevention, early detection, screening, and treatment affect breast cancer outcomes.

The Confluence Project , from NCI's Division of Cancer Epidemiology and Genetics (DCEG) , is developing a research resource that includes data from thousands of breast cancer patients and controls of different races and ethnicities. This resource will be used to identify genes that are associated with breast cancer risk, prognosis, subtypes, response to treatment, and second breast cancers. (DCEG conducts other breast cancer research as well.)

The Black Women’s Health Study (BWHS) Breast Cancer Risk Calculator allows health professionals to estimate a woman’s risk of developing invasive breast cancer over the next 5 years. With the NCI-funded effort, researchers developed a tool to estimate the risk of breast cancer in US Black women. The team that developed the tool hopes it will help guide more personalized decisions on when Black women—especially younger women—should begin breast cancer screening. 

The goal of the Breast Cancer Surveillance Consortium (BCSC) , an NCI-funded program launched in 1994, is to enhance the understanding of breast cancer screening practices in the United States and their impact on the breast cancer's stage at diagnosis, survival rates, and mortality.

There are ongoing programs at NCI that support prevention and early detection research in different cancers, including breast cancer. Examples include:

• The  Cancer Biomarkers Research Group , which promotes research in cancer biomarkers and manages the Early Detection Research Network (EDRN) . EDRN is a network of NCI-funded institutions that are collaborating to discover and validate early detection biomarkers. Within the EDRN, the Breast and Gynecologic Cancers Collaborative Group conducts research on breast and ovarian cancers.
• NCI's Division of Cancer Prevention  houses the Breast and Gynecologic Cancer Research Group which conducts and fosters the development of research on the prevention and early detection of  breast and gynecologic cancers.

Breast Cancer Survivorship Research

NCI’s Office of Cancer Survivorship, part of the Division of Cancer Control and Population Sciences (DCCPS), supports research projects throughout the country that study many issues related to breast cancer survivorship. Examples of studies funded include the impact of cancer and its treatment on physical functioning, emotional well-being, cognitive impairment , sleep disturbances, and cardiovascular health. Other studies focus on financial impacts, the effects on caregivers, models of care for survivors, and issues such as racial disparities and communication.

Breast Cancer Clinical Trials

NCI funds and oversees both early- and late-phase clinical trials to develop new treatments and improve patient care. Trials are available for breast cancer prevention , screening , and treatment . 

Breast Cancer Research Results

The following are some of our latest news articles on breast cancer research and study updates:

• Can Some People with Breast Cancer Safely Skip Lymph Node Radiation?
• Study Adds to Debate about Mammography in Older Women
• Pausing Long-Term Breast Cancer Therapy to Become Pregnant Appears to Be Safe
• A Safer, Better Treatment Option for Some Younger Women with Breast Cancer
• Shorter Course of Radiation Is Effective, Safe for Some with Early-Stage Breast Cancer
• Pembrolizumab Improves Survival in Advanced Triple-Negative Breast Cancer

View the full list of Breast Cancer Research Results and Study Updates .

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Volume 25 Supplement 2

Symposium Mammographicum Conference 2023

• Meeting abstracts
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• Published: 10 October 2023

Symposium Mammographicum 2023

Breast Cancer Research volume  25 , Article number:  122 ( 2023 ) Cite this article

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W7.1 Can axillary surgery be tailored based on response to neoadjuvant chemotherapy assessed with CEUS?

Mariana afonso matias 1 ; nisha sharma 1 ; isobel haigh 1 ; rebecca millican-slater 1 ; raj achuthan 1 ; yan chen 2, 1 leeds teaching hospital nhs trust; 2 university of nottingham, correspondence : mariana afonso matias.

Breast Cancer Research 2023, 25 (Suppl 2) :W7.1

Background: This feasibility study was designed to evaluate if contrast-enhanced ultrasound (CEUS) can identify node-positive patients before neoadjuvant chemotherapy (NACT) and assess the residual cancer burden within the axilla following NACT and therefore, potentially tailor the surgical treatment of the axilla.

Methods: 32 patients were identified of which 26 met the inclusion criteria and underwent CEUS pre and post NACT. The sentinel lymph nodes (SLNs) identified during CEUS were biopsied and clipped. All 26 participants of this study underwent axillary node clearance (ANC) along with breast conservative surgery or mastectomy. Axillary specimens were further reviewed considering the number of positive nodes and if nodes clipped during CEUS were positive or negative.

Results: Following NACT, among the 26 participants, CEUS identified positive SLNs in 8 patients. Post ANC, histology showed that 7/8 of these patients had positive nodes. The remaining 18 patients were found to be node negative on CEUS post NACT. Furthermore, post ANC, the histology of 12 of these patients showed positive nodes with a tumour burden ranging from 1 to 18 LNs. Further analysis showed that in 25% of these patients the identified positive nodes were non SLNs.

Conclusions: The study shows that although the SLN maybe negative post NACT that non-SLNs may still be malignant and therefore a negative SLN does not translate into a negative axillary clearance. Therefore further studies looking at the role of targeted axillary dissection such as the ATNEC trial are important to support de-escalation of axillary surgery in the context of NACT.

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W7.2 Mammographic density and breast cancer risk factors: Systematic review and meta-analysis

Dixa thakrar ; zoe grenville; trishna desai; toral gathani; gillian k reeves; isobel barnes, cancer epidemiology unit, nuffield department of population health, university of oxford, correspondence : dixa thakrar.

Breast Cancer Research 2023, 25 (Suppl 2) :W7.2

Background: Mammographic density (MD) is an important risk factor for breast cancer and reduces mammographic screening sensitivity (1,2). There are several breast cancer risk factors which have been consistently shown to be associated with MD, including age, menopausal status, BMI, and menopausal hormone therapy (3–9). However, the associations of some lifestyle and reproductive factors with MD are uncertain. We conducted a systematic review to examine the associations of alcohol, smoking, parity, age at first birth and age at menarche, with MD.

Methods: Articles published between 2000 and 2021, reporting the associations of the risk factors of interest with age-adjusted MD, were identified. Study quality was assessed using tools from the Joanna Briggs Institute. Fixed-effects meta-analyses were conducted to synthesise the results.

Results: Fifty-nine studies were included. Pooled results suggested that increased alcohol intake, and later age at first birth and menarche were associated with increased MD, while increased parity and smoking were associated with decreased MD: e.g. odds ratio (OR) for higher MD in alcohol drinkers versus non-drinkers was 1.15 (95%CI 1.06–1.25; p = 0.001) and OR for parous versus nulliparous women was 0.68 (0.65–0.71; p < 0.001). There was significant statistical heterogeneity among studies.

Conclusions: There is some evidence that lifestyle and reproductive risk factors are associated with MD. Several studies were small with heterogeneous results, limiting reliable interpretation of the findings. Further work using data from a large prospective study is planned, to reliably investigate how these risk factors influence screening sensitivity and breast cancer risk, through their effects on MD.

McCormack VA, Dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: A meta-analysis. Cancer Epidemiology Biomarkers and Prevention. 2006;15(6):1159–69.

Weigel S, Heindel W, Heidrich J, Hense HW, Heidinger O. Digital mammography screening: sensitivity of the programme dependent on breast density. Eur Radiol. 2017 Jul 1;27(7):2744–51.

Azam S, Jacobsen KK, Aro AR, Lynge E, Andersen ZJ. Hormone replacement therapy and mammographic density: a systematic literature review. Breast Cancer Res Treat [Internet]. 2020;182(3):555–79. Available from: https://doi.org/10.1007/s10549-020-05744-w

Checka CM, Chun JE, Schnabel FR, Lee J, Toth H. The relationship of mammographic density and age: Implications for breast cancer screening. American Journal of Roentgenology. 2012;198(3):292–5.

Burton A, Maskarinec G, Perez-Gomez B, Vachon C, Miao H, Lajous M, et al. Mammographic density and ageing: A collaborative pooled analysis of cross-sectional data from 22 countries worldwide. PLoS Med. 2017;14(6):1–20.

Moore JX, Han Y, Appleton C, Colditz G, Toriola AT. Determinants of Mammographic Breast Density by Race Among a Large Screening Population. JNCI Cancer Spectr. 2020;0:1–10.

Hart V, Reeves KW, Sturgeon SR, Reich NG, Sievert LL, Kerlikowske K, et al. The effect of change in body mass index on volumetric measures of mammographic density. Cancer Epidemiology Biomarkers and Prevention. 2015;24(11):1724–30.

Sprague BL, Gangnon RE, Burt V, Trentham-Dietz A, Hampton JM, Wellman RD, et al. Prevalence of mammographically dense breasts in the United States. J Natl Cancer Inst [Internet]. 2014 Oct;106(10). Available from: http://www.ncbi.nlm.nih.gov/pubmed/25217577

Titus-Ernstoff L, Tosteson ANA, Kasales C, Weiss J, Goodrich M, Hatch EE, et al. Breast cancer risk factors in relation to breast density (United States). Cancer Causes and Control. 2006;17(10):1281–90.

W7.3 Retrospective audit of patients with breast pain referred to the Bristol breast care centre

Kanika kaushal 1 ; alexandra valencia 2, 1 royal liverpool university hospital; 2 north bristol nhs trust, correspondence : kanika kaushal.

Breast Cancer Research 2023, 25 (Suppl 2) :W7.3

Objectives: A retrospective audit at the Bristol breast care centre was performed to

Establish the incidence of breast cancer in patients referred with breast pain and whether patients diagnosed with cancer had other symptoms

Assess P value for the clinical exam

Establish cancer visibility on mammography

Methods: Review of Imaging and clinical notes of 26/2952 women referred with breast pain from July 2020 to June 2021 and diagnosed with breast cancer.

17/24 cancers were diagnosed in the area of concern, 7/24 were incidental, 15/17 cancers in women over the age of 40

12/17 patients had pain and lump at the site of clinical concern, 1/17 had pain and nipple inversion, 1/17 had lump only, 3/17 had pain only

P values for clinical exams were as follows:

GP 10/17 patients lump felt (59%), 6/17 (35%) referred as suspicious

Surgeon/NP—15/17 patients (88%), 3/17- P2, 4/17- P3, 8/17 (47%)- P4/5

13/17 (76%) MXR in women over 40 reported as M4/5

3/2952 (0.1%) patients referred with breast pain only were diagnosed with cancer in the area of concern

7/2952 (0.2%) had incidental cancers

Conclusion:

Most women referred with breast pain to the one-stop clinic did not have a diagnosis of cancer

24/2952 (0.81%) cases referred for breast pain had breast cancer

Just 3/2952 (0.1%) had breast pain only at diagnosis

Most women diagnosed with cancer had an additional symptom, mostly breast lumps

Most cancers were seen on mammography, which was more specific than the clinical examination P value

W7.4 Breast lesions incidentally detected on CT- audit of cases referred to a one stop breast clinic

Olivia taylor-fry ; shahrooz mohammadi, st georges nhs trust, correspondence : olivia taylor-fry.

Breast Cancer Research 2023, 25 (Suppl 2) :W7.4

Background: The increasing use of cross sectional imaging has led to more incidental breast lesions being detected. An increasing number of patients are therefore referred to breast clinic following incidental findings on CT.

Objective: To look at the referral pathway following detection of a breast abnormality on CT, outcome of assessment and waiting times.

Method: Retrospective search of RIS (March-Nov 2020): all CT referrals that included chest imaging were included. Those that had subsequent specific breast imaging were reviewed, and all CT reports were assessed to see if reference was made to breast investigation or breast lesions to determine whether the CT/Radiology had initiated the breast referral.

Data collected: patient demographics, radiological findings, time to be seen in breast clinic, imaging characteristics of the CT findings, dedicated breast imaging findings, and final pathology.

3535 CT examinations performed from March to Nov 2020.

78 referred to the Breast Unit. 36% (n = 28) had biopsies, 64% of cases (n = 50) no biopsies were required.

17% of the CT referred incidental breast lesions were malignant.

Referral type: 38/78 referrals advised correct referral pathway via the one stop breast clinic/ triple assessment in the CT report.

14/78 CT reports did not mention specific breast referrals (although breast pathology was mentioned in the CT report).

Waiting times: 26 patients seen in breast one stop within 14 days of CT performed.

30 waited over 28 days.

Conclusions: Propose new pathway to involve breast radiologist.

Georgieva M. Rennert J. Brochhausen C. Stroszczynski C. Jung EM. (2021) Suspicious breast lesions incidentally detected on chest computed tomography with histopathological correlation. The Breast journal. 27: 715–722

Hussain A, Gordon-Dixon A, Almusawy H, Sinha P, Desai A. (2010) The incidence and outcome of incidental breast lesions detected by computed tomography. Ann R Coll Surg Engl 2010; 92: 124–126

Lin W, Hsu H. Li C (2011) Incidentally detected enhancing breast lesions on chest computed tomography. Korean Journal of Radiology. 12:44–45.

Prionas N. Lindfors K. Ray S (2010) Contrast enhanced dedicated breast CT: initial clinical experience. Radiology 256(3): 714–723

Moyle P. Sonoda L. Britton P. Sinnatamby R (2010) Incidental breast lesions detected on CT: what is their significance? The British Journal of Radiology 83: 233–240

W7.5 Incidental breast lesions on cross-sectional studies -impact of an alternated referral pathway BREAST 1 code

Anusha subramanian; richard sidebottom; iain lyburn; sarah vinnicombe, thirlestaine breast centre cheltenham, correspondence : sarah vinnicombe.

Breast Cancer Research 2023, 25 (Suppl 2) :W7.5

Background : Increasing numbers of breast lesions are identified on body cross-sectional studies, resulting in increased referrals to symptomatic Breast clinics, often unnecessary.

An automatic triage system was developed to manage these. Dictation of the code BREAST1 in a report on identification of a breast "incidentaloma" triggers a dedicated email to breast radiology. After review and comparison with prior breast imaging, an addendum is dictated, indicating whether referral is necessary.

Study Aim :  To evaluate the impact of the BREAST1 referral pathway on numbers of referrals to the Breast clinic and clinical outcomes.

Method :  A retrospective analysis of all referrals with the BREAST1 code between December 2018 and October 2022.

Results :  Of 372 instances:

No action was necessary in 191 patients (51%) with longstanding or benign findings.

Referral to the Breast clinic was recommended in 165 patients (44%).

27 (16%) were not referred due to comorbidities. 3 were subsequently diagnosed with invasive cancer at the same site.

138 were referred:

51 (31%) with benign findings did not require biopsy.

Of 87 biopsies, 49 (30%) were malignant and 38 (23%), benign.

Referral to Oncology for MDT discussion was advised in 8 (2%).

The email alert system failed to alert breast radiology on 8 occasions (2%).

Conclusion :  The automated referral pathway BREAST1 resulted in a 51% reduction of referrals to the Breast Unit with resultant benefit to patients and clinicians. For those referred, there were high PPVs for malignancy (29.6% for referral, 56% for biopsy) with timely assessment and diagnosis.

Incidental Breast Lesions Detected on Computed Thorax Tomography—Necdet Poyraz Ganime Dilek Emlik, Suat Keskin, Havva Kalkan; J Breast Health 2015; 11: 163–7. https://doi.org/10.5152/tjbh.2015.2656

The incidence and outcome of incidental breast lesions detected by computed tomography A Hussian A Gordon-Dixon H Almusawy, P Sinha A Desai; Ann R Coll Surg Engl 2010; 92: 124–126. https://doi.org/10.1308/003588410X12518836439083

3B.1 Can a specificity-focused PERFORMS case set affect the performance of breast screening readers?

Yan chen 1 ; jonathan j james 2 ; eleni michalopoulou 1 ; iain t darker 1, 1 university of nottingham; 2 nottingham university hospitals nhs trust, correspondence : yan chen.

Breast Cancer Research 2023, 25 (Suppl 2) :3B.1

Background: All breast screening readers in the UK are required to participate in an external quality assurance scheme using test sets, known as PERFORMS. Recent work has shown that PERFORMS accurately reflects real-life mammography reading performance, indicating that it can be a useful tool in maintaining the high reading standards of the NHS breast screening programme 1–2. Each test set consists of sixty cases that are typically enriched with challenging cancers as well as normal and benign studies and are made available twice per year.

Methods: In October 2021, an innovative change was made to the scheme with a case set designed to test and assist the readers in identifying mammographic features that do not need recall for further investigation, aimed at tackling a growing number of false positive recalls. This novel optional 'specificity set' was delivered in the same way as a traditional PERFORMS set.

Results: 409 readers across the UK examined the cases. 317 of them took part in pre- (SA15 Part1) and post- (SA16 Part1) specificity rounds. The results showed that the recall rate was significantly lower in SA16 Part1 (34.5%) than in SA15 Part1 (37.1%) amongst those who undertook the specificity set, while the correct return to screen rate was significantly higher in SA16 Part1 (88.0%) than in SA15 Part1 (83.3%) amongst those who undertook the specificity set.

Conclusion: The specificity set was shown to be a very useful exercise, highlighting that an individual’s performance can be altered by implementing targeted training programmes.

Chen Y, James JJ, Michalopoulou E, Darker TI, Jenkins J. The relationship between missed breast cancers on mammography in a test-set based assessment scheme and real-life performance in a National Breast Screening Programme. Eur J Radiol. 2021 Sept; 142:109881. https://doi.org/10.1016/j.ejrad.2021.109881

Chen Y, James JJ, Cornford E, Jenkins J. The Relationship between Mammography Readers’ Real-Life Performance and Performance in a Test Set–based Assessment Scheme in a National Breast Screening Program. Radiol Imaging Cancer. 2020 Sep 25;2(5):e200016. https://doi.org/10.1148/rycan.2020200016 .

3B.2 A comparison of contrast enhanced mammography and magnetic resonance imaging in the evaluation of breast disease: A systematic review

Bethan williams, anuerin bevan university health board, correspondence : bethan williams.

Breast Cancer Research 2023, 25 (Suppl 2) :3B.2

Design : Systematic review of quantitative studies with a narrative synthesis.

Background : Accurate assessment and timely diagnosis of breast cancer is crucial for successful treatment and good prognosis (1,2).

Previous research has shown promise of CEM being comparable to MRI as a problem-solving tool for breast disease (3). Limited systematic reviews appraising this subject. Review aims to collate English language literature regarding comparison of CEM and MRI at evaluating breast disease, determining the modalities comparability in breast disease evaluation.

Methodology : A systematic review of quantitative studies was undertaken. CINHAL, Embase, Medline, Cochrane Library, Joanna Briggs Institute, Web of Science, TRIP, Prospero and Scopus. Two reviewers independently assessed studies for methodological quality.

Results : Nine moderate to high quality prospective and retrospective comparative studies, with a total of 853 participants and 1514 lesions were located. No studies which addressed overall diagnostic accuracy or sizing accuracy noted any statistically significant difference (p-value =  > 0.05) between CEM and MRI. Varying results were noted with regards to sensitivity and specificity, some studies showed statistically significance whereas others demonstrated no difference.

Conclusion : There is consistent evidence to suggest that CEM is comparable to MRI in the evaluation of breast disease. Research suggests MRI is slightly more sensitive, however, CEM is more specific. Sizing lesion accuracy was considered comparable, although both modalities overestimated the size of lesions when compared with histopathology. The use of CEM in multi-focal breast cancer has not been addressed in this review, however, for lesion classification and preoperative staging CEM is considered suitably comparable to MRI.

Drukteinis JS, et al. Beyond Mammography: New Frontiers in Breast Cancer Screening. Am J Med. 2013;126(6):472–79

Loberg M. et al. Benefits and harms of mammography screening. Breast Ca Res. 2015;17(1)

Patel BK, et al. Contrast Enhanced Spectral Mammography: A Review. Semm in Ultrasound, CT and MRI: 2018;39(1);70–9

3B.3 Temporal enhancement features on contrasted enhanced mammography (CEM): Comparison with breast MRI

Malavika rajeev ; sarah savaridas awarded best short paper, university of dundee, correspondence : malavika rajeev.

Breast Cancer Research 2023, 25 (Suppl 2) :3B.3

Introduction : Contrast enhanced mammography (CEM) is a functional imaging technique with similar accuracy to MRI. (1,2) Time-intensity curves derived from MRI images provide additional functional information. (3) We sought to produce similar data for CEM and compare with respective MRI curves.

Methods: This retrospective image-analysis study included women with enhancing mass-lesions on CEM and comparative MRI studies. Early MLO and delayed MLO views were acquired, 3 and 9 min post-contrast administration respectively. CEM lesions were segmented using freehand and ellipsoid-ROIs on initial and delayed MLO views by a radiologist blinded to MRI. The mean, 90th and 99th centile greyscale values (GSV) were recorded, and temporal change calculated. Differences between the CEM temporal enhancement according to MRI-curve type were calculated using a Mann Whitney U test.

Results: 55 lesions were identified, 19 produced type-1 curves, one a type-2 curve and 35 type-3 curves. The solitary type-2 curve lesion was excluded from statistical analysis. Lesions with MRI type-1 curves demonstrated increasing CEM 90th and 99th centile GSVs, lesions with type 3 curves demonstrated decreasing CEM 90th and 99th centile GSVs. Whilst mean values demonstrated less variation between cohorts, all values differed significantly between cohorts, p  < 0.05. Differences in CEM temporal enhancement was greatest for Ellipsoid-ROI 99th centile: temporal GSV 4.58 vs − 9.97, p  = 0.001 and Ellipsoid-ROI 90th centile: temporal GSV 2.58 vs − 7.91, p  = 0.002, for type-1 and type-3 curves respectively.

Discussion: Significant differences in CEM temporal GSV are demonstrated between MRI curve types. Results were most promising for ellipsoid-ROIs and 99th and 90th centile GSVs.

Daniaux M, de Zordo T, Santner W, Amort B, Koppelstätter F, Jaschke W, et al. Dual-energy contrast-enhanced spectral mammography (CESM). Vol. 292, Archives of Gynecology and Obstetrics. Springer Verlag; 2015. p. 739–47.

Xiang W, Rao H, Zhou L. A meta-analysis of contrast-enhanced spectral mammography versus MRI in the diagnosis of breast cancer. Thorac Cancer. 2020 Jun 1;11(6):1423–32.

Wang LC, DeMartini WB, Partridge SC, Peacock S, Lehman CD. MRI-detected suspicious breast lesions: Predictive values of kinetic features measured by computer-aided evaluation. American Journal of Roentgenology. 2009 Sep;193(3):826–31.

3B.4 Evaluation of an AI tool to measure mammographic density for use in a future FAST MRI trial

Sandra gomes 1 ; mark halling-brown 1 ; ken young 1 ; matthew trumble 1 ; lyn jones 2 ; katherine klimczak 2 ; jan rose 3 ; tony timlin 2 ; lucy warren 1, 1 royal surrey nhsfoundation trust; 2 north bristol nhs trust; 3 independent cancer patients' voice, correspondence : sandra gomes.

Breast Cancer Research 2023, 25 (Suppl 2) :3B.4

Background: Supplemental screening trials of FAST MRI will require validated assessment of mammographic-density to identify inclusion criteria. A research AI tool has previously been developed to predict breast density from processed mammograms (1). The AI tool requires validating prior to consideration for use in future studies.

Aim: To evaluate the accuracy and reliability of a previously developed research AI tool, for use in a future FAST MRI trial.

Methods: Processed mammograms acquired on Hologic X-ray systems and their Volpara (version 1.5.4) 5th Edition BI-RADS density classifications from unprocessed images were collected for 12,627 women from two UK screening sites(2). Inclusion criteria specified mammograms from women most likely to benefit from supplemental screening (age 50–55, first screen). BI-RADS classifications from the AI tool were compared, to those from Volpara (ground truth). 95% confidence intervals, calculated using 1000 bootstrap samples were used to compare performance across age groups and ethnicity.

Results: The percentage of women in BI-RADs categories a, b, c and d respectively correctly categorised by the AI tool was 85% (95%CI: 82–88), 87% (95%CI: 86–88), 81% (95%CI: 80–82) and 83% (95%CI: 82–85).

Within each BIRADs category, the 95% confidence intervals across age and ethnicity overlapped, indicating the difference in performance was not statistically significant.

The distribution of cases was 6%, 42%, 34% and 18% for BIRADs a, b, c and d for Volpara. This compared with 9%, 42%, 32% and 17% for the AI tool.

Conclusions: These results demonstrate comparable performance of the AI tool at mammographic-density categorisation to the ground truth Volpara.

Lucy M. Warren, Peter Harris, Sandra Gomes, Matthew Trumble, Mark D. Halling-Brown, David R. Dance, Louise Wilkinson, Ros Given-Wilson, Kenneth C. Young, "Deep learning to calculate breast density from processed mammography images," Proc. SPIE 11513, 15th International Workshop on Breast Imaging (IWBI2020), 115131C (22 May 2020); https://doi.org/10.1117/12.2561278

Mark D. Halling-Brown, Lucy M. Warren, Dominic Ward, Emma Lewis, Alistair Mackenzie, Matthew G. Wallis, Louise S. Wilkinson, Rosalind M. Given-Wilson, Rita McAvinchey, and Kenneth C. Young, " OPTIMAM Mammography Image Database: A Large-Scale Resource of Mammography Images and Clinical Data ," Radiology: Artificial Intelligence 2021 3:1; https://pubs.rsna.org/doi/full/10.1148/ryai.2020200103

3B.5 Imaging and breast cancer characteristics influence mammography artificial intelligence output and detection

Sarah lewis ; ziba gandomkar; phuong dung yun trieu; seyedamir tavakoli-taba; melissa barron; zhengqiang jiang, the university of sydney, faculty of medicine and health, correspondence : sarah lewis.

Breast Cancer Research 2023, 25 (Suppl 2) :3B.5

Purpose: The value of Artificial Intelligence (AI) models for breast cancer detection are being robustly debated in professional discourse yet the quality of image input, segmentation and demographic data is often overlooked or underreported alongside performance results. This study investigates a range of image and cancer characteristics that affect the performance of mammography-based AI models (Globally-aware Multiple Instance Classifier (GMIC); Global–Local Activation Maps (GLAM)).

Methods: An Australian data set of 856 screening mammography cases with a biopsy-proven malignancy were viewed by two expert breast radiologists who segmented the cancer location, aided by the pathological report. From this data, concordance values were computed and calculated using Lin’s concordance correlation coefficient and were assessed against projection type (Medio-lateral oblique (MLO), Crandio-caudal (CC)), breast density (BD) and cancer size. The annotations and concordance levels were then matched to the saliency maps of GLAM and GMIC.

Results: Chi-squared analysis shows concordance values between radiologists were higher for the CC view compared with MLO (P = 0.0001), and higher concordance for lower BD cases (P = 0.0016). ANOVA analysis shows significantly greater concordance for larger cancers (P = 0.03). The two AI models performed strongest when ‘almost perfect’ concordance was used, as opposed to weaker levels of concordance measured by saliency map overlap between radiologists and AIs.

Conclusion: The evaluation of the performance of AI models should include a multi-factorial approach to understanding the quality of input information (segmentation, concordance, views, density and cancer sizes). Segmentation and concordance can assist in demonstrating the AI output fluctuations and trustworthiness.

3B.6 A comparison of digital mammography and phase contrast tomography for visualisation of breast cancers

Sarah lewis 1 ; sharon alexander 1 ; patrick brennan 1 ; timur gureyev 2 ; mary rickard 1 ; darren lockie 3 ; jane fox 4 ; seyedamir tavakoli-taba 1, 1 the university of sydney; 2 the university of melbourne; 3 breastscreen victoria; 4 monash health.

Breast Cancer Research 2023, 25 (Suppl 2) :3B.6

Purpose : Two-dimensional (2D) digital mammography (DM) is the current gold standard in breast cancer screening and diagnostic imaging however limitations exist with superimposition tissues and poor contrast between healthy and cancerous tissues, particularly in dense breasts. Phase-contrast computed tomography (PCT) is a novel three-dimensional (3D) imaging approach utilising both absorption properties and refraction information of X-rays. PCT has the potential to provide additional information for breast cancer diagnosis 1 . This study aims to assess the clinical usefulness of PCT imaging compared with DM via radiological subjective visualisation of excised cancers.

Methods : Thirty patients underwent mastectomies, and the excised samples were subsequently imaged with PCT. The pre-surgery DM images were obtained as well as the post-surgical histological results. The 30 cases included benign cases, 22 breast cancers of varying types and a range of breast densities. A training package to allow radiologists to interpret the PTC images was developed and after completion, 2 expert breast imaging radiologists read the DM and PCT images, giving a rating of confidence as to visualisation of the cancers.

Results : The results show that most of the lesions were adequately visualised and detectable in PCT and DM (88%, 19/22 cases). Lower confidence was expressed with visualising high-grade DCIS lesions and LCIS lesions in DM imaging, compared with PCT and lower confidence of visualisation of Invasive Lobular Carcinoma with PCT than DM. A pictorial essay of cases is included.

Conclusion : PCT subjective visualisation of excised cancers was equal to DM, with new research underway to image women pre-surgery.

1 Gureyev, TE, Nesterets, YI, Baran, PM, Taba, ST, Mayo, SC, Thompson, D, et al. "Propagation-based x-ray phase-contrast tomography of mastectomy samples using synchrotron radiation". Med Phys . 46 (12):5478–87. 2019. [ https://doi.org/10.1002/mp.13842 ]

P01 Development of phantoms for protocol optimisation and quality assurance testing for a multi-centre abbreviated magnetic resonance imaging breast study

Sian curtis 1 ; holly elbert 1 ; jonathon delve 1 ; sam stewart-maggs 1 ; anna wang 2 ; liz o'flynn 3 ; sadie mckeown-keegan 4 ; maria schmidt 5 ; mark halling-brown 6 ; lyn jones 4, 1 university hospitals bristol and weston nhs foundation trust; 2 university of oxford; 3 st george’s university hospitals foundation trust; 4 north bristol nhs trust; 5 royal marsden nhs foundation trust and institute of cancer research; 6 royal surrey county hospital nhs foundation trust, correspondence : sian curtis.

Breast Cancer Research 2023, 25 (Suppl 2) :P01

Background: Previous studies have indicated that aggressive cancers, not well visualised on mammograms, can be identified on an abbreviated magnetic resonance imaging (MRI) breast protocol called FAST MRI [1,2].

The aim of this study was to design and develop dedicated phantoms for protocol optimisation and standardised quality assurance testing for a future multi-centre FAST MRI study.

Methods : A contrast phantom was developed by testing the responsiveness of MRI contrast agents to small changes in clinical sequence parameters and assessing their stability and reproducibility (Fig.  1 a and b).

A geometric phantom was developed by investigating different construction methods and target designs with comparison to expected clinical scan parameters (Fig.  1 c).

Results: Contrast phantom: The measured T1 values agreed with the literature for Gadolinium and Nickel Chloride solutions and were found to be independent of temperature and position within the magnetic field. Signal enhancement showed strong sensitivity to changes in clinical sequence parameters (Fig.  2 a and b) and a linear relationship existed between signal enhancement and concentration for T1 values in the range 25–3000 ms.

Geometry Phantom: A design was chosen which included a range of resolution test targets to allow swift visual evaluation and in-depth analysis and performance tracking (Fig.  2 c and d).

Conclusion: A contrast and geometry phantom were designed and assessed for optimisation of FAST MRI breast sequences and quality assurance testing; both phantoms fit inside a standard breast MRI coil. The phantoms have the potential to be incorporated into NHSBSP technical guidance for MRI equipment quality assurance testing.

Geach R, Jones LI, Harding SA, Marshall A, Taylor-Phllips S, McKeown-Keegan S, Dunn JA. The potential utility of abbreviated breast MRI (FAST MRI) as a tool for breast cancer screening: a systematic review and meta-analysis. Clinical Radiology. 2021; 76(2): 154.e11–154.e22

Vinnicombe S, Harvey H, Healy NA, Papalouka V, Schiller A, Moyle P, Kilburn-Toppin F, Allajbeu I, Sharma N, Maxwell AJ, Payne N, Graves M, Gilbert FJ. Introduction of an abbreviated breast MRI service in the UK as part of the BRAID trial: practicalities, challenges, and future directions. Clinical Radiology. 2021; 76(6): 427–433

P02 Learning to read FAST MRI: Qualitative interviews with groups experienced reading mammograms

Rebecca geach ; lyn jones; sam harding, north bristol nhs trust, correspondence : rebecca geach.

Breast Cancer Research 2023, 25 (Suppl 2) :P02

Purpose: Abbreviated breast MRI (abMRI) is being introduced in breast screening trials and clinical practice, particularly for women with dense breasts. Upscaling abMRI provision requires the workforce of mammogram readers to be able both learn and subsequently implement the reading of the abMRI images. The present study explores the acceptability of the implementation of developed reader training, and the barriers and facilitators to participating in the training programme and subsequently reading the study training images in a work/NHS context familiar to the individual participants.

Methods: Fourteen mammogram readers participated in semi-structured interviews. Template analysis using the a priori implementation framework, COM-B was undertaken.

Results: The training day was well received. Participants identified that their varying ranges of knowledge and experience (capability) was accounted for, whilst feeling included. Participation in the research was appreciated by all, but especially those new to reading MRI.

Radiographers commented that learning to read and understand the FAST MRI images was motivational, and this helped drive implementation. It was noted that organisational leadership is needed to fully enable change in practice. COVID-19 was commented on in relation to its impact on image reading.

Conclusions: The project demonstrates that production of training for reading abMRI images and subsequent implementation of changes to practice needs to be carefully planned. Changes must be led by the needs of staff undertaking the tasks. When this is achieved the engagement in training is positive and the barriers are more readily removed or mitigated for both individuals and organisations.

P03 Take a break: Should we be implementing breaks in DBT reporting sessions?

Adnan taib 1 ; george partridge 1 ; michael michell 2 ; yan chen 1, 1 university of nottingham; 2 king's college hospital nhs foundation trust, correspondence : adnan taib.

Breast Cancer Research 2023, 25 (Suppl 2) :P03

Purpose: We compared changes in diagnostic accuracy and fatigue levels over a Digital Breast Tomosynthesis (DBT) reporting session, with and without breaks.

Materials: 45 National Health Service breast screeners, from 6 breast screening centres, who participated in the UK PROSPECTS trial (NCT03733106) from December 2020 to April 2022, read a malignant-loaded set of 40 DBT cases while eye tracked in this prospective cohort study: 21 screeners had a break in their reporting session, 24 screeners did not. The eye tracker recorded eye-blink duration, assessed as an objective fatigue measure. Subjective fatigue questionnaires were completed before and after the session (unit: %). Changes in diagnostic accuracy, objective and subjective fatigue measures overtime and between cohorts were analysed (α-level was set at 0.05).

Results: Participant screeners had a median of 10 years post-training breast screening experience and the mean time to report all 40 cases was 105.8 min. Screeners in the no break cohort reported greater levels of mean subjective fatigue (no break: 44% vs. break: 33%; p = 0.04) which was related to a greater average blink duration (no break: 296 ms vs. break: 286 ms; p < 0.001). Blink duration also increased as the trial progressed for the no break cohort only (p < 0.001). No evidence of a difference was identified in diagnostic performance between the groups (p = 0.92).

Conclusions: Implementing a break during a 2-h DBT reporting session resulted in lower levels of subjective and objective fatigue. Breaks did not impact diagnostic accuracy; but this may be related to the extensive experience of the screeners.

P04 Developing QA and QC protocols for 3D automated breast ultrasound (ABUS)

Clara márquez moreno 1 ; nicholas payne 2 ; oliver morrish 1 ; fiona gilbert 2, 1 cambridge university hospitals nhs foundation trust; 2 university of cambridge, correspondence : clara márquez moreno.

Breast Cancer Research 2023, 25 (Suppl 2) :P04

Introduction : The B reast Screening— R isk A daptive I maging for D ensity (BRAID) trial is a multicentre study focused on women within the NHS breast screening programme (NHSBSP) who have radiographically dense breast tissue. BRAID is investigating the potential benefit of supplemental imaging techniques to improve cancer detection. One of the modalities used in BRAID is 3D Automated Breast Ultrasound (ABUS).

Method : Ultrasound systems used clinically within the NHSBSP are tested following NHSBSP Publication No 70 however, this publication only covers quality assurance of 2D ultrasound systems. Therefore, we are developing a testing procedure for physicists and users using 3D ABUS systems, building on the guidance provided by national standards [1,2] and advice from the manufacturer of the equipment [3].

Results : The three Invenia ABUS 2.0 scanners (GE Healthcare) used within the BRAID trial are checked by physics on a six-monthly basis while user testing is carried out on a weekly and monthly basis. We are collecting, analysing, and assessing the utility of the data obtained and the tests performed during these visits. An outline of the current protocol and example results from this testing will be presented.

Conclusions : Initial physics and users written procedures are working documents. They are reviewed and updated based on physics and local data and feedback obtained from clinical users. The aim is that, by the end of the trial, this work will produce quality assurance and quality control protocols that could be adopted nationally to test ABUS systems.

Dall B, Dudley N, Hanson M, Moore S, Seddon D, Thompson W, Prashant V. Guidance Notes for the Acquisition and testing of Ultrasound Scanners for Use in the NHS Breast Screening Programme (NHSBSP Publication No 70). NHS Cancer Screening Programmes 2011.

Dudley N, Evans T, Hoskins P, Watson A, Starritt H. Quality Assurance of Ultrasound Imaging Systems (IPEM Report No 102). Institute of Physics and Engineering in Medicine 2010.

Model UC-551 m Instruction Manual, ATS Laboratories, A CIRS Company Norfolk, VA).

P05 Enabling AI research, development and validation using the OPTIMAM mammography imaging database (OMI-DB)

Dominic ward; lucy warren ; zahida zahoor; andrew joiner; alistair mackenzie; emma lewis; ken young; mark halling-brown, royal surrey nhs foundation trust, correspondence : lucy warren.

Breast Cancer Research 2023, 25 (Suppl 2) :P05

Background: The development and validation of Artificial Intelligence (AI) to improve the outcomes of breast screening depends on the availability of well-curated, representative databases (1). OMI-DB (2) was created to provide an annotated dataset to facilitate R&D. Screening mammograms and associated clinical data were collected for screen-detected cancers, interval cancers and large samples of routine-recall cases from UK screening centres since 2011. The collection is continuous.

Results/Usage: OMI-DB comprises 6,441,765 mammograms from 426,629 cases; a breakdown of screening cases is presented in Table 1 .

OMI-DB is used in virtual clinical trials investigating the effect of factors on breast cancer detection and evaluating cancer characteristics and breast density. More recently, several studies have evaluated algorithms at different stages of development, from prototypes to commercial products. Unseen validation subsets have been retained for independent model validation. OMI-DB and its associated infrastructure are currently supporting multiple AI trials, evaluations and deployments (e.g. the AIMS project; (3)). OMI-DB has been shared with 70 groups, primarily for the development of machine learning.

Discussion : A national-scale research database has been developed. The provision of processed/unprocessed images, its large size, the availability of NBSS data and expert-determined ground truth are essential for the safe development and validation of AI.

The availability of sequential-screening events and interval cancers presents many research opportunities, including whether an abnormality could have been detected earlier. The database is continuously expanding to ensure data are representative of screening centres across the NHSBSP.

Debelee TG, Schwenker F, Ibenthal A, Yohannes D. Survey of deep learning in breast cancer image analysis. Evol Syst. 2020 Mar; 11:143–163. Available from: https://doi.org/10.1007/s12530-019-09297-2

Halling-Brown MD, Warren LM, Ward D, Lewis E, Mackenzie A, Wallis MG, Wilkinson LS, Given-Wilson RM, McAvinchey R, Young KC. OPTIMAM mammography image database: a large-scale resource of mammography images and clinical data. Radiol Artif Intell. 2020 Nov 25;3(1):e200103. Available from: https://doi.org/10.1148/ryai.2020200103

Imperial College London. AI in Mammography Screening (AIMS) [internet]. 2023 [cited 2023 Jan 10]. Available from: https://www.imperial.ac.uk/global-health-innovation/what-we-do/research/data-science-and-analytics/artificial-intelligence/ai-in-mammography-screening-aims/

P06 Diagnostic performance of synthetic mammogram alone or with digital breast tomosynthesis Vs full-field digital mammogram in breast cancer screening: A systematic review

Wasim hamad 1 ; jonathan myles 1 ; michael j michell 2 ; fiona gilbert 3 ; john loveland 4 ; stephen w duffy 1, 1 queen mary university of london; 2 king’s college hospital; 3 university of cambridge; 4 royal surrey county hospital, correspondence : wasim hamad.

Breast Cancer Research 2023, 25 (Suppl 2) :P06

Background: Digital Breast Tomosynthesis (DBT) has been shown to be effective in breast cancer screening. However, the use of DBT and full field digital mammography (FFDM) together exposes the screenee to increased radiation. A synthetic mammogram (S2D) is a two-dimensional image that can be constructed from DBT. In this review, we evaluated the performance of S2D alone or in conjunction with DBT compared to FFDM alone or with DBT.

Methods: A systematic search was conducted on Embase and Medline up to January 2023. Screening was conducted by two reviewers, with disagreement resolved by consensus. Studies were included if they included only screening participants and reported on the performance of S2D either alone or in combination with DBT. Studies were excluded if they included symptomatic patients, imaging was diagnostic, or if they included patients with a history of breast cancer.

Results: We identified 3241 records, of which 93 underwent full-text screening, and 16 were finally included. In studies reporting comparisons of cancer detection rates (CDR) between DBT + S2D and FFDM, CDRs ranged from 5.9 to 13.5/1000 for DBT + S2D. The range for FFDM was 3.5 to 9.1/1000. In studies reporting comparisons of sensitivity, the sensitivities for DBT + S2D were 69–94%, and those for FFDM 45–92%. Specificities ranged from 68 to 98% for DBT + S2D, and from 60 to 98% for FFDM. Comparison of DBT + S2D with DBT + FFDM and comparison of S2D with FFDM were consistent with these.

Conclusion: S2D showed similar or better performance when used with DBT compared to FFDM in breast cancer screening.

P07 Sub-lesion level temporal enhancement characteristics of lesions on CEM: A comparison with MRI

Calum gray 1 ; tom macgillivray 1 ; sarah savaridas 2, 1 university of edinburgh; 2 university of dundee, correspondence : sarah savaridas.

Breast Cancer Research 2023, 25 (Suppl 2) :P07

Introduction : Contrast enhanced mammography (CEM) is a functional imaging technique with similar accuracy to MRI (1). However, additional functional data can be derived from MRI images using time-intensity curves, and due to the heterogeneity of breast cancers, analysis is performed at sub-lesion level to identify the most aggressive features. It may be possible to assess temporal enhancement on CEM. Initial publications compared the enhancement level of initial view (invariably CC) with subsequent view (invariably MLO). (2, 3) Results were promising but limited by the compound effect caused by assessing the greyscale levels of three-dimensional lesions using differing two-dimensional views. Subsequent work has successfully quantified change in enhancement using an early and delayed MLO views. (4) However, to date all research has been limited to assessing the change in enhancement of an entire lesion.

Rationale: In a proof-of-principle study of 15 cases, we demonstrated that it was possible to achieve registration with good agreement between early and delayed MLO views. This study will progress that work and perform assessment of temporal enhancement of CEM images at a sub-lesion level and compare this to respective MRI curves.

Methods: CEM images were performed as part of prospective imaging studies, all patients had contemporaneous MRIs. MLO views were acquired 3 and 9 min after contrast injection. Rigid and non-rigid registration techniques will be applied to spatially align the images. Subtraction images with colour maps will be produced. Foci demonstrating the most aggressive temporal enhancement features will be segmented. CEM and MRI temporal enhancement features will be compared.

Xiang W, Rao H, Zhou L. A meta‐analysis of contrast‐enhanced spectral mammography versus MRI in the diagnosis of breast cancer. Thoracic Cancer. 2020;11(6):1423–32.

Deng C-Y, Juan Y-H, Cheung Y-C, Lin Y-C, Lo Y-F, Lin G, et al. Quantitative analysis of enhanced malignant and benign lesions on contrast-enhanced spectral mammography. The British Journal of Radiology. 2018:20170605.

Liu Y, Zhao S, Huang J, Zhang X, Qin Y, Zhong H, et al. Quantitative Analysis of Enhancement Intensity and Patterns on Contrast-enhanced Spectral Mammography. Scientific Reports. 2020;10(1).

Xu W, Zheng B, Chen W, Wen C, Zeng H, He Z, et al. Can the delayed phase of quantitative contrast-enhanced mammography improve the diagnostic performance on breast masses? Quant Imaging Med Surg. 2021;11(8):3684–97.

P08 FAST MRI interpretation-training: Using formative assessment to map the learning curve of multi-professional NHS breast screening programme (NHSBSP) mammogram-readers and to optimise diagnostic accuracy for FAST MRI (grant-funded by the National Breast Imaging Academy)

Lyn jones 1 ; andrea marshall 2 ; rebecca geach 1 ; tony timlin 1 ; elizabeth o'flynn 3 ; sadie mckeown-keegan 1 ; sarah vinnicombe 4 ; sian taylor-phillips 5 ; mark halling-brown 6 ; janet dunn 2, 1 north bristol nhs trust; 2 warwick clinical trials unit; 3 st george's university hospitals nhs foundation trust; 4 gloucestershire hospitals nhs foundation trust; 5 university of warwick; 6 royal surrey nhs foundation trust, correspondence : lyn jones.

Breast Cancer Research 2023, 25 (Suppl 2) :P08

Background : A FAST MRI interpretation-training programme was adapted for remote e-learning delivery and used to train multi-professional NHSBSP mammogram-readers. The training (current iteration) included formative assessment through interpretation of an enriched dataset (ground-truth feedback provided immediately following participants’ reading of each scan).

Methods : Per-breast analysis was obtained overall and for each reader. Differences in accuracy, sensitivity and specificity across reader groups were analysed using a multilevel generalised mixed model to account for multiple readers per case and restricted cubic splines (4 knots to the number of cases read) to plot participants’ learning curves.

Results : 43 NHSBSP mammogram-readers completed the training. 22 interpret breast MRI in their clinical role (Group 1) and 21 do not (Group 2). 7/22 in Group 1 had previously undertaken FAST MRI training as a research participant and 13/22 had not, whilst 7/21 in Group 2 had previously undertaken FAST MRI training and 14/21 had not.

Overall sensitivity was 83% (95%CI 81–84%; 1994/2408), specificity 94% (95%CI 93–94%; 7806/8338) and readers’ agreement with the true outcome kappa = 0.75 (95%CI 0.74–0.77).

Group 1 readers showed similar sensitivity (84%) to Group 2 (82% p = 0.14), but higher specificity (94% v. 93%, p = 0.001).

Specificity (p < 0.001) and accuracy (p = 0.003) improved during formative assessment for all groups of readers, but sensitivity did not (p = 0.24).

Conclusions : Two days’ remote e-learning enabled multi-professional mammogram-readers, including those new to FAST MRI interpretation (Group 2), to achieve sensitivity and specificity within benchmarks published for full-protocol breast MRI (1).

Sickles E, D’Orsi C. ACR BI‐RADSâ Follow‐up and Outcome Monitoring. In ACR BI-RADSâ Atlas, Breast Imaging Reporting and Data System. 5th ed. Reston, VA: American College of Radiology; 2013. Available from: https://www.acr.org/Clinical‐Resources/Reporting‐and‐Data‐Systems/Bi‐Rads/Permissions

P09 How long does it take to read a mammogram?

George partridge 1 ; iain darker 1 ; jonathan james 2 ; michael michell 3 ; yan chen 1, 1 university of nottingham; 2 nottingham breast institute, nottingham university hospitals (nuh); 3 kings college hospital, correspondence : george partridge.

Breast Cancer Research 2023, 25 (Suppl 2) :P09

Background : Research shows that use of digital breast tomosynthesis (DBT) can improve diagnostic accuracy compared to digital mammography (2DDM) alone, however, DBT images are more complex and the reporting time is longer.

Purpose : To investigate differences in screening reporting time using 2DDM compared to DBT + 2DDM and DBT + S2D (synthetic 2D), and the effect of screener experience level by employing a large-scale dataset. Additionally, to investigate how DBT reporting time changes over a three-year period as the readers' screening experience with DBT increases.

Methods: PROSPECTS is a national UK prospective trial (NCT03733106) investigating the efficacy and cost-effectiveness of DBT. From January 2019-November 2022, 63 NHS breast screeners from 6 participating breast screening centres double read these clinics, equating to 41,324 2DDM and 12,084 DBT + 2D images, and recorded their reporting session durations. T-tests, ANOVAs and regression are employed to determine statistical significance, as appropriate (α-level was set at 0.05).

Results : All data has been collected and results show that the mean time to report a DBT case is double that of a 2DDM case (2.78 min vs. 1.27 min, respectively; p = 0.002). The time to report DBT + S2D cases was statistically equivalent to DBT + 2DDM cases (2.88 min vs. 2.68 min, respectively; p = 0.08). The experience data will be included in the conference presentation.

Conclusions : Analysis of this large-scale dataset shows that DBT reporting time is greater than 2DDM alone and that DBT + S2D and DBT + 2DDM reporting time is equivalent. We hypothesise that the reporting time will reduce with accrued experience using DBT as a screening tool.

P10 Radiologists performance in DBT using online and PACS-based education tools for breast cancer detection

Sarah lewis ; melissa barron; phuong dung yun trieu.

Breast Cancer Research 2023, 25 (Suppl 2) :P10

Background: Digital Breast Tomosynthesis (DBT) is a mainstream imaging method for early breast cancer detection and ongoing education is vital for strong diagnostic performance. This study investigated the diagnostic performance of readers interpreting a DBT test set in two modes: through PACS (Picture Archiving and Communication System) or online directly through the BREAST (Breast Screen Reader Assessment Strategy) cloud-based platform.

Methods: A DBT test set consisting of 10 biopsy-proven cancer and 20 normal case was read by Group 1: 30 readers (23 radiologists, 7 trainees) using PACS and entering their results on the BREAST platform; and Group 2: 23 readers (17 radiologists, 6 trainees) readers without PACS and direct annotation onto BREAST. Readers marked any suspicious lesions on the best corresponding DBT slice and rated the lesions for levels of malignancy suspicion. Readers’ performances were compared with truth data and evaluated in specificity, sensitivity, ROC AUC and JAFROC FOM. Both had the average experience of 5 years reading DBT cases.

Results: There was no significant difference between two reading modes between Group 1 and 2 for any metric (P > 0.05). Radiologists performed slightly better without PACS in all metrics, with a significant result in ROC AUC (0.79-vs-0.74; P = 0.027).

Conclusion: Readers demonstrated equivalent performance when reading DBT cases via PACS and without PACS, with an improved ROC AUC performance for radiologists. Online education platforms such as BREAST that have evolved past PACS technology can be very effective for training and self-assessment and can provide greater access for learning.

P11 Self-assessment modules in mammography, lessons learned and future innovations

Patrick brennan 1 ; moe suleiman 2 ; ziba gandomkar 2 ; mary rickard 2 ; noelle clerkin 3, 1 detectedx & university of sydney; 2 detectedx; 3 belfast breast unit, correspondence : patrick brennan.

Breast Cancer Research 2023, 25 (Suppl 2) :P11

Background: Self-assessment modules (SAMs), have educated expert breast radiologists for three decades. Following millions of user test set interactions we can now document what SAMs have achieved and outline where future innovations should be focussed.

Methods: BREAST and DetectedX test sets which provide a variety of mammographic SAMs have been used by clinicians in Australasia, Asia, Europe and the US as a method to improve early detection of breast cancer whilst cultivating abilities to recognise normality. Whilst it is generally agreed that SAMs have provided an essential clinical service, it is also recognised that evolution is required to embrace modern day innovations such as artificial intelligence (AI).

Results: Clinical performance significantly improves with the use of SAMs regardless of experience and training of the user, with particular benefits shown for cancer detection. In addition the multiple interactions of clinicians with SAMs has yielded valuable insights [1,2] resulting in more than 100 publications and multiple research student theses. New knowledge on radiologist behaviours and characteristics that affect image interpretation has been provided. However, it is now timely for SAMs to reassess their place in the modern educational arena in terms of access, duration, accreditation, interactivity and AI. The data presented summarises achievements and describes potential future pathways.

Conclusions: Much has been achieved with SAMs, however with the emergence of new technologies and user expectations they must now evolve and embrace new opportunities that will help optimise and tailor educational deliveries.

P12 Breast screening for transgender people: How confident are we? Awarded Caroline Roney Prize

Emily gilbert, nottingham breast institute, correspondence : emily gilbert.

Breast Cancer Research 2023, 25 (Suppl 2) :P12

Purpose: Many transgender people are invited for breast screening in the UK (1), yet there is limited research on how we can support this community. NHS England provides guidance on service adjustments to accommodate transgender individuals (2), but there is currently no specific training advised for mammographers. This study aims to explore how confident mammographers are in screening transgender people. This includes confidence in their knowledge, using appropriate terminology, and understanding how the service could adapt. The aim is to also explore whether mammographers have had training around this topic, and if they feel they require any.

Methods: A quasi-structured questionnaire was carried out by a volunteer sample of mammographers (N = 10). Some questions were presented as a Likert scale (3), and were analysed as ordinal data using a measure of central tendency (mean). Other questions were open, and were analysed thematically.

Results: Mammographers had low confidence levels in using appropriate terminology (mean = 4.4, whereby 0 = not confident at all and 10 = very confident). Mammographers also had fairly low confidence in understanding why transgender people may or may not be invited for screening (mean = 5.6). Emerging themes included feeling anxious about getting things wrong, and feeling unsure about adaptations. None of the mammographers had received training around the topic, and 80% said they would like training.

Conclusions: Improvements should be made in teaching mammographers about the transgender community in relation to breast screening. Increasing mammographers' knowledge and confidence could lead to service improvements for transgender people. The author has produced a pilot information leaflet for existing mammographers and trainees.

Public Health England. Breast screening: Guidance for breast screening mammographers [Internet]. gov.uk. [cited 2022 Dec 22]. Available from: https://www.gov.uk/government/publications/breast-screening-quality-assurance-for-mammography-and-radiography

NHS England. NHS Population Screening: Information for trans and non-binary people [Internet]. gov.uk. [cited 2022 Dec 22]. Available from: https://www.gov.uk/government/publications/nhs-population-screening-information-for-transgender-people/nhs-population-screening-information-for-trans-people

McLeod SA. Likert scale [Internet]. Simply Psychology. [cited 2022 Dec 22]. Available from: https://www.simplypsychology.org/likert-scale.html

P13 Can we de-escalate surgical treatment for DCIS?

Aisling eves 1 ; andrew pieri 2 ; ross mclean 2 ; nerys forester 2, 1 newcastle university; 2 royal victoria infirmary, correspondence : aisling eves.

Breast Cancer Research 2023, 25 (Suppl 2) :P13

Background: DCIS accounts for 20% of malignancies diagnosed by the breast screening programme and is primarily managed by surgical excision. This study aims to investigate how often DCIS is fully removed via core biopsy, thereby negating the need for surgery .

Methods: This was a single-centre retrospective cohort study of 101 consecutive breast screened patients diagnosed with DCIS who underwent surgical excision. All patients diagnosed with DCIS had radiological abnormalities < 15 mm. Clinical, radiological, and histological data were collected from patients who had been diagnosed within a 5-year period, and a complete excision by core biopsy was defined as 0 mm of DCIS found in the surgical specimen.

Results: Complete DCIS excision following core biopsy was 21.8% (n = 22). The median mammographic size of DCIS was 8 mm (range: 4–14 mm), median number of cores was 8 (3–16) and median biopsy weight was 1.82 g (1.1–7.5 g). There were no significant differences in mammographic size (10 mm, p = 0.06), number of cores (9, p = 0.14), or biopsy weight (2.73, p = 0.26) for those who had incomplete excision. Complete excision was seen in 40% of low-grade, 29% of intermediate-grade, and 16% of high-grade DCIS cases (p = 0.19).

Conclusion: There are no clear factors which predict complete excision by core biopsy in screen-detected DCIS. It is possible that DCIS < 15 mm could be excised with VAE techniques but further investigations are needed to determine this. In low-grade DCIS further work could be considered due to higher rates of complete excision with core-biopsy. We would recommend following relevant guidelines to proceed to surgical excision where appropriate.

P14 Clinical outcomes for patients diagnosed with DCIS through the breast screening programme

Breast Cancer Research 2023, 25 (Suppl 2) :P14

Background: This study investigated the clinical outcomes (re-excision rates, radiotherapy usage, and presence of invasive cancer) for patients following surgical excision of small-volume DCIS.

Methods: This was a single-centre retrospective cohort study of 101 consecutive breast-screened patients diagnosed with DCIS who underwent surgical excision. All DCIS patients had radiological abnormalities < 15 mm. Clinical, radiological, and histological data were collected from patients diagnosed within 5-years, and ASCO guidelines for margin involvement < 2 mm was used to guide the need for re-excision.

Results: Breast conservation surgery was performed in 94.1% (n = 95). Following surgical excision, 74 (73.27%) patients had complete DCIS excision (> 2 mm margin), 4 (4.0%) had margins 1–2 mm, and 17 (16.84%) had margins < 1 mm. The median size of DCIS in the specimen sample was 4 mm. In 86% of patients with involved margins (n = 18), the mammogram underestimated DCIS size by a median of 12.5 mm (range: 1–42 mm). Of the patients with involved margins, 11 (10.9%) had a re-excision, with 6 (50%) requiring two re-excisions to achieve complete DCIS excision. Post-operative radiotherapy was provided to 53 (52.48%). Four (3.97%) patients had invasive ductal carcinoma on surgical excision which was not present on core biopsy. Recurrence of DCIS in the same site occurred in 1 patient (1%), 1-year after first DCIS diagnosis.

Conclusion: Breast conservation surgery is safe in DCIS patients, with low rates of re-excision, recurrence and upstaging to invasive cancer. Furthermore, the median size of DCIS found in the specimens of patients with total DCIS removal was small suggesting that VAE could be used to totally remove DCIS in these patients.

P16 Radiography advanced practitioners' clinical background: Impact upon interpretation performance

Noelle clerkin 1 ; patrick brennan 2 ; chantal ski 1 ; ruth strudwick 1, 1 university of suffolk; 2 university of sydney, correspondence : noelle clerkin.

Breast Cancer Research 2023, 25 (Suppl 2) :P16

Purpose: The efficacy of a breast cancer screening programme relies on efficient analysis of mammograms. Readers that interpret mammograms must meet the high standards of their peers (1,2). This study will for the first time identify the clinical background implications that impact the performance of UK Radiography Advanced Practitioners (RAP). This data will assist in identifying norms for the assessment of diagnostic efficacy.

Methods : The performance of 22 UK-based RAPs reading a cloud-based test set of 60 mammographic cases with known truth was assessed using the software platform DetectedX. Sensitivity and specificity values were established for each RAP, T or Mann–Whitney tests were used to explore the impact of clinical background on image interpretation accuracy.

Results: Reader sensitivity was significantly affected by the weekly volume of reads undertaken (P ≤ 0.0001), number of annual readings (P ≤ 0.0001), average reading session length (P ≤ 0.0001), type of cancer presented on imaging (P ≤ 0.0001), breast speciality (P ≤ 0.0001) and years in the role (P ≤ 0.0001). Specialists in breast imaging (P ≤ 0.04) and their preferred time of day to read (P ≤ 0.04) impacted their specificity. Normative performance values were indicated.

Conclusions: For the first time this work has identified specific features that impact the performance of UK RAPs interpreting mammograms. Through identified causal agents for varying performance suggested are ways in which future diagnostic activity can be optimised. These findings provide a framework for the assessment of standards, available to all RAPs.

Kundel, H., Nodine, C. and Carmody, D., 1978. Visual Scanning, Pattern Recognition and Decision-making in Pulmonary Nodule Detection. Investigative Radiology , 13(3), pp.175–181.

Rawashdeh MA, Lee WB, Bourne RM, Ryan EA, Pietrzyk MW, Reed WM, et al. Markers of good performance in mammography depend on number of annual readings. Radiology. 2013;269(1):61–7

P17 Experience as an international mammographer working in the UK- comparing practice between Nigeria and UK

Chizoba rita okeke; ginikanwa njoku, royal shrewsbury and telford hospital nhs trust, correspondence : ginikanwa njoku.

Breast Cancer Research 2023, 25 (Suppl 2) :P17

Breast cancer affects women of all races without exception even though severity and survival rate are often diverse. In Nigeria about two thirds of women with breast cancer are diagnosed at an advanced stage, with the possibility of metastatic spread (Akaro-Anthony et al., 2010).

A mammographer performs breast imaging techniques that produce mammographic radiographs for diagnosis (American Society of Radiologic Technologist, 2017).

In Nigeria, the breast screening programme is performed by radiographers with the additional mammogram-specific training which is comparable to what is found in the United Kingdom; however, the UK screening programme also makes use of trained assistant practitioners which is not obtainable in Nigeria (Lawal et al., 2015).

The breast screening programme in Nigeria invites women between the ages of 40 to 70 years, and this is justified by the fear that in Nigeria, a higher percentage of breast cancer cases are seen in younger age groups than in developed world ((Jedy-Agba et al., 2012). The mode of invitation is through public awareness campaigns, but majority of the women in the population do not frequently participate in mammography screening due to high cost and religious belief. The screening programme in Nigeria encourages women to get screened every two years (Lawal et al., 2012).

However, the UK breast screening programme advice women to have breast screening mammogram, once every 3 years and is currently inviting women between the ages of 50 and 70 years for breast screening.

Akarolo-Anthony SN, Ogundiran TO, Adebamowo CA (2010) Emerging breast cancer epidemic: evidence from Africa. Breast Cancer Res. 12 Suppl 4:S8.

American Society of Radiologic Technologists (ASRT). The Practice Standards for Medical Imaging and Radiation Therapy US: American Society of Radiologic Technologists; 2017:1–29.

Jedy-Agba, E. et al . (2012) "Cancer incidence in Nigeria: A report from population-based cancer registries," Cancer Epidemiology , 36(5).

Lawal, O., Murphy, F.J., Hogg, P., Irurhe, N. and Nightingale, J. (2015). Mammography screening in Nigeria—A critical comparison to other countries. Radiography , 21(4), pp.348–351. https://doi.org/10.1016/j.radi.2015.03.015 .

Maroni, R., Massat, N.J., Parmar, D., Dibden, A., Cuzick, J., Sasieni, P.D. and Duffy, S.W. (2020). A case–control study to evaluate the impact of the breast screening programme on mortality in England. British Journal of Cancer . https://doi.org/10.1038/s41416-020-01163-2 .

Pittathankal, A. and Davidson, T. (2010). Care pathways for patients with breast cancer. Trends in Urology, Gynaecology & Sexual Health , 15(2), pp. 10–13. https://doi.org/10.1002/tre.144 .

P18 Women's perspectives of molecular breast imaging

Helen elliott 1 ; alison bray 1 ; nerys forester 1 ; will jones 2 ; clare lendrem 2 ; timothy powell 1 ; jason scott 3, 1 newcastle upon tyne hospitals nhs foundation trust, university of newcastle; 2 nihr newcastle in vitro diagnostics co-operative; 3 northumbria university, correspondence : helen elliott.

Breast Cancer Research 2023, 25 (Suppl 2) :P18

Background : Mammography used for breast screening has poor sensitivity in dense tissue (1) . Retrospective studies suggest that Molecular Breast Imaging (MBI), used for screening in the USA but not the UK, has superior diagnostic accuracy (2,3) . Patient perspectives of MBI are unknown and crucial to understand feasibility of adoption into the NHS.

Method: Semi-structured interviews with screened and unscreened women exploring the acceptability of MBI. Data were analysed thematically.

Results: Five themes were generated from 19 interviews: (1) scan duration, (2) radiation dose, (3) equity of access, (4) comfort in familiarity and (5) need for shared decisions relating to risk. Participants found the 40-min scan duration to be acceptable. Radiation dose was also acceptable, especially once participants understood that higher breast density was linked to cancer risk. Some participants were concerned about access issues such as parking if MBI scans were hospital-based, raising issues around equitable access. Participants expressed obtaining comfort in existing screening processes with which they were familiar, and participants with experience of nuclear medicine tests were less concerned about radiation dose. Finally, participants placed considerable trust in the NHS to evaluate tests, pointing to a need for uncertainty in screening decisions to be more effectively discussed to support shared decision making.

Conclusion: MBI is an acceptable breast imaging modality for UK women. Women wish to be offered personalised, risk-based screening, with tests that offer favourable risk–benefit ratios. High-quality patient information enabling informed decision-making is essential. Further work is needed to understand how MBI will fit into existing screening pathways.

Kolb TM, Lichy J, Newhouse JH. Comparison of the Performance of Screening Mammography, Physical Examination, and Breast US and Evaluation of Factors that Influence Them: An Analysis of 27,825 Patient Evaluations. Radiology. 2002;225(1):165–75.

Kim BS, Moon BI, Cha ES. A comparative study of breast-specific gamma imaging with the conventional imaging modality in breast cancer patients with dense breasts. Ann Nucl Med. 2012;26(10):823–9.

Rhodes DJ, Hruska CB, Conners AL, Tortorelli CL, Maxwell RW, Jones KN, et al. Journal club: molecular breast imaging at reduced radiation dose for supplemental screening in mammographically dense breasts. AJR Am J Roentgenol. 2015;204(2):241–51.

P20 Evaluating the radiological features and characteristics of interval breast cancers in a UK breast screening programme

Cheryl stubbs 1 ; amy symons 2 ; elizabeth muscat 1 ; elizabeth o' flynn 1 ; cathie morris 1, 1 st george's healthcare nhs trust; 2 kingston university, correspondence : cheryl stubbs.

Breast Cancer Research 2023, 25 (Suppl 2) :P20

Background : Every year approximately 6000 women have an interval cancer diagnosed 1. 80% of interval cancers have no sign of the subsequent cancer on the screening mammogram, however 20% do, representing a false negative interval cancer (FNIC). We have evaluated the radiological features and characteristics of FNIC’s in an NHSBSP breast unit.

Methods : A retrospective service evaluation of all FNIC was performed between 1/1/2016 and 1/1/2022. For each FNIC anatomical position, breast density, mammographic appearance and image quality were evaluated.

Results : 33% of FNIC underwent paired arbitration: 87% were not recalled for assessment and 13% were which were subsequently discharged to routine screening. 3% had clinical symptoms.

Anatomical position: 64% the abnormality was seen on both views in the upper outer quadrant, 17.5% in the lower inner quadrant, 16% posteriorly, 10% retroareolar and 6% at the site of post-surgical change.

Breast density: 14% (BI-RADS A), 46% (BI-RADS B), 36% (BI-RADS C) and 4% (BI-RADS D).

Mammographic appearance: 61% asymmetry: 28.5% slowly developing asymmetry, 74% focal asymmetry, 26% only seen on one view, 6% associated with calcification. Figure 2 demonstrates the distribution of tumour characteristics within each breast density.

Image quality: 11.5% were impacted by image quality at the site of the abnormality.

Conclusions : Review of screen detected cancers may yield additional cases which can facilitate further learning. Training in recognition of significant clinical symptoms and a review of the clinical symptoms protocol could prevent further cases.

Public Health England (2021) NHS screening: helping you decide: London: Public Health England

P21 When clips migrate following a vacuum-assisted procedure, does the technique affect the distance of migration?

Hannah giles ; andrea da silva; geetanjali kakar; neil upadhyay, imperial college healthcare nhs trust, correspondence : hannah giles.

Breast Cancer Research 2023, 25 (Suppl 2) :P21

Learning objective: Assess the difference in the distance of clip migration between lateral arm biopsy approach (LABA) and vertical conventional biopsy approach (CBA) when performing vacuum assisted procedures.

Background: Vacuum-assisted procedures under stereotactic or tomosynthesis guidance allows sampling of mammographically detected abnormalities.

Clip migration occurs in up to 44% of cases [1]. There are several potential contributary factors, such as the accordion effect. It is hypothesised that approach, LABA or CBA, may affect migration.

The poster aims to compare the mean distance of clip migration in CBA and LABA procedures using the T-test, to ascertain whether the degree of clip migration is affected.

Results: The Radiology Information System was searched with key term “migr” to account for “migration” or “migrated”, yielding 70 results between 2015 and 2022.

55 were CBA, 11 were LABA and 4 were excluded.

Breast density (BIRADS classification), age, approach and clip migration distance were recorded. The mean distance of migration for CBA was 28 mm and 24 mm for LABA (p = 0.49).

Conclusion: There was no statistically significant difference in the mean distance of migration between CBA and LBA approaches, suggesting that technique does not affect the extent of clip migration.

Limitations: The search used the term “migr” and therefore reports using alternative vocabulary to describe migration would not have been captured. As this is likely to affect cases of CBA and LABA equally, it would be unlikely to introduce bias.

Weaver et al. Insights into Imaging (2021) 12:193 https://doi.org/10.1186/s13244-021-01136-w

P22 What lies outside the breast- incidental extra-mammary findings on MRI

Lauragh mc carthy ; elisabetta giannotti, addenbrookes hospital, cambridge, correspondence : lauragh mc carthy.

Breast Cancer Research 2023, 25 (Suppl 2) :P22

Background: Breast MRI has superior anatomical resolution and larger field of view than other breast imaging techniques and is the only one to include extramammary structures.

According to previous studies 16.8%–34% of breast MRI examinations demonstrate incidental extramammary findings. Benign lesions are the most common findings. Malignant lesions need to be excluded especially as many breast MRI patients have newly diagnosed breast cancer and such significant findings would influence patient management.

The aim of this study was to determine the prevalence and site of extramammary findings on breast MRI.

Method: Retrospective review of all Breast MRI’s over a 12 month period from January to December 2022 in a single institution was performed.

929 examinations were reviewed.

Results: Extramammary incidental findings were identified in 98 of the 929 examinations (10.5%).

6.1% were malignant findings (3 lung, 2 bone, 1 chest wall); one was a new diagnosis of sarcoidosis (1/98 1%) and one a deep venous thrombosis (1/98 1%).

The most common incidental finding was hepatic cysts 61.2% (60/98). The next most common findings were retrosternal goitre, hepatic haemangioma and cardiovascular findings each identified in 6/98 6.1%.

Conclusion: When reporting breast MRI it is essential to examine and review extra-mammary structures to exclude the presence of findings which might have a significant clinical impact on patient management and care.

Niell BL, Bennett D, Sharma A, Gazelle GS. Extramammary findings on breast MR examinations: frequency, clinical relevance, and patient outcomes. Radiology 2015;276(1):56–64

Rinaldi P, Costantini M, Belli P, et al. Extra-mammary findings in breast MRI. Eur Radiol 2011;21(11):2268–2276.

P24 Contrast enhanced mammography guided biopsy (CEMGB) to the rescue: A case-based step by step guide to this versatile technique for biopsy of lesions occult on standard imaging Awarded Best Poster

Rachel sun ; ramona menezes, nottingham university hospitals, correspondence : rachel sun.

Breast Cancer Research 2023, 25 (Suppl 2) :P24

Background: Contrast Enhanced Mammography (CEM) is a dual energy acquisition technique using a single compression. It relies on tumour neo-angiogenesis, highlighted by intravenous iodinated contrast. A low energy exposure is performed followed by a high energy exposure (above the k-edge of iodine) using copper filtration. These images are processed to generate a recombined image that supresses background tissue and highlights areas of tumour enhancement.

Our unit introduced CEM in 2013 and recently implemented CEM guided biopsy—CEMGB. CEMGB utilises CEM principles alongside conventional stereotactic guidance. It allows targeting of lesions that are occult on conventional imaging but visible on recombined images.

The procedure is performed using standard stereotactic techniques that most radiographers will be familiar with. The process is straight-forward when staff have been trained appropriately and are familiar with CEM. It can be performed in breast clinic with minimal preparation, and the potential for diagnosis at first patient attendance.

Objectives: To present a CEM case and provide a step-by-step guide to performing a CEMGB with the General Electric (GE) Pristina mammography machine. We provide tips and tricks and potential pitfalls.

Conclusion: CEMGB is a promising technique to biopsy lesions occult on conventional imaging. It has the potential to be a cheaper, faster and more widely available alternative to MRI guided breast biopsy.

P25 Percutaneous vacuum-assisted excision (VAE) of breast lesions of uncertain malignant potential (B3) as an alternative to diagnostic surgical excision. Experience of a large screening service

Maria carrillo ; heba hussein; marianna telesca, worcestershire acute hospitals, correspondence : maria carrillo.

Breast Cancer Research 2023, 25 (Suppl 2) :P25

Objective: Standard treatment for B3 lesions has been surgical excision. The benign post-surgical outcome of majority of B3 lesions called for a less invasive approach such as VAE. This retrospective study aims to assess the impact of VAE as alternative to diagnostic surgical excision in the management of screen detected B3 lesions in a large screening service (population 150,000).

Method: 82 B3 lesions on 14 g core biopsy were referred for VAE between 2018 and 2021. Pathological information on initial 14 g biopsy and final VAE/surgical histology were obtained. VAE data collection included: image guidance (mammography/ultrasound), needle size (7/10 g), number and weight of samples.

Results: On VAEs 33/82 lesions had no atypia and 49/82 had atypia. VAE was performed under mammography (48/82) or ultrasound (34/82). 44 VAEs performed with 10 g needle with an average of 11.8 samples (mean sample weight 3.75 gr). 38 VAEs performed with a 7 g needle with an average of 11.4 samples (mean sample weight 5.12 gr).

On final histology, 11/82 cases (13.4%) were upgraded to malignancy requiring surgical management. 61/82 (74.4%) cases did not require further treatment and returned to routine screening. 10/82 (12.1%) cases were offered increased annual surveillance for 5 years as per NHSBSP guidelines. Up to the time of the abstract, no new malignancy has occurred at site of VAE.

Conclusion: 71/82 (86.5%) cases had VAE as final treatment and did not require any further surgical management demonstrating VAE is an effective method to treat screen detected B3 breast lesions.

Elisabetta Giannotti, Jonathan J. James, Yan Chen, Rachel Sun, Amanjot Karuppiah, Julia Yemm, Andrew H. S. Lee. Effectiveness of percutaneous vacuum-assisted excision (VAE) of breast lesions of uncertain malignant potential (B3 lesions) as an alternative to open surgical biopsy. European Radiology. 2021 Dec;31(12):9540–9547.

P27 Is the 3 mm tolerance for axillary node biopsy still adequate for indication of axillary disease? Retrospective audit

Linda deane ; lucy cielecki; sue williams; marie metelko; mahmoud alkouly; umit aksoy; jayne vaughan; sian burley; elizabeth barlow; ellen cobby, shrewsbury and telford hospital nhs trust, correspondence : linda deane.

Breast Cancer Research 2023, 25 (Suppl 2) :P27

Background: A 3 mm tolerance for cortical thickness on axillary lymph nodes is a standard measurement used as one of the thresholds to decide if potentially suspicious for disease. Our department conducted an audit of the ultrasound outcomes for lymph node involvement in the axilla after several unexpected positive post-surgical cases with previously negative axillae on ultrasound, were obtained. This could impact the patient directly if further axillary surgery was required.

Method: 12 months of ultrasound results were compared to the pathology results for surgical axillary biopsy, lymph node sampling and surgical axillary clearance.

Results: Forty-seven cases out of 388 cases were false negative. Sensitivity was 41.25% and specificity was 91.56%.

Analysis: Nineteen cases were excluded due to morphological data unavailable at the time of the audit. Twenty-eight cases analysed either revealed disease too small to be visualised, positive nodes not in the axilla, not biopsied by a second consultant when returning for biopsy procedure and learning difficulties. All these cases were conducted by different consultants on different ultrasound units. No identifiable trend was seen.

Conclusion: The sensitivity is in keeping with peer review investigations and therefore the 3 mm threshold for identifying possible disease is still adequate. Any learning points from individual cases were taken forward to aid with service improvement.

Saffar, B., Bennett, M., Metcalf, C., & Burrows, S. Retrospective preoperative assessment of the axillary lymph nodes in patients with breast cancer and literature review. Clinical Radiology. 2015. 70 (9), 954–959. https://doi.org/10.1016/j.crad.2015.04.019

Bedi, D. G., Krishnamurthy, R., Krishnamurthy, S., Edeiken, B. S., Le-Petross, H., Fornage, B. D., Bassett, R. L., & Hunt, K. K. Cortical Morphologic Features of Axillary Lymph Nodes as a Predictor of Metastasis in Breast Cancer: In Vitro Sonographic Study. American Journal of Roentgenology. 2008. 191 (3), 646–652. https://doi.org/10.2214/AJR.07.2460

Luparia, A., Campanino, P., Cotti, R., Lucarelli, D., Durando, M., Mariscotti, G., & Gandini, G. Role of axillary ultrasound in the preoperative diagnosis of lymph node metastases in patients affected by breast carcinoma. Radiologia Medica. 2010. 115 (2), 225–237. https://doi.org/10.1007/s11547-009-0465-8

Elmore, L. C., Appleton, C. M., Zhou, G., & Margenthaler, J. A. Axillary ultrasound in patients with clinically node-negative breast cancer: which features are predictive of disease? The Journal of Surgical Research. 2013. 184 (1), 234–240. https://doi.org/10.1016/j.jss.2013.03.068

Deurloo, E.., Tanis, P.., Gilhuijs, K. G.., Muller, S.., Kröger, R., Peterse, J.., Rutgers, E. J. T., Valdés Olmos, R., & Schultze Kool, L. Reduction in the number of sentinel lymph node procedures by preoperative ultrasonography of the axilla in breast cancer. European Journal of Cancer. 2003. 39 (8), 1068–1073. https://doi.org/10.1016/S0959-8049(02)00748-7

Sanders, M. M., Waheed, S., Joshi, S., Pogson, C., & Ebbs, S. R. The importance of pre-operative axillary ultrasound and intra-operative sentinel lymph node frozen section analysis in patients with early breast cancer—A 3-year study. Annals of the Royal College of Surgeons of England. 2011. 93 (2), 103–105. https://doi.org/10.1308/003588411X12851639108196

Rooney, E. G., Fleming, M. M., Patel, J. G., Clifford, K., Kim, C., Chen, Z., Gillespie, T. W., Arciero, C. A., & Subhedar, P. D. Are Lymph Node Characteristics on Axillary Ultrasound Associated with ≥ 3 Positive Lymph Nodes in Patients Managed by the American College of Surgeons Oncology Group Z0011 Trial Criteria? The American Surgeon. 2018. 84 (7), 1133–1137. https://doi.org/10.1177/000313481808400726

P28 Complications of image guided breast biopsies at a breast screening hospital: A prospective review

Sharmeen jaffer ; janet sedgwick; gillian bowman; lucy diss; michael michell; rema wasan; charlotte longman; adam brown; clare peacock; nikhil patel; bhavana batohi; keshthra satchithananda; juliet morel, king's college hospital, correspondence : sharmeen jaffer.

Breast Cancer Research 2023, 25 (Suppl 2) :P28

Background: Core biopsies are the gold standard technique for diagnostic breast biopsies in the United Kingdom.1 There are a plethora of techniques for sampling including stereotaxis, tomosynthesis, ultrasound and MRI guided vacuum assisted/core biopsies. While procedural optimisation is key, complications do arise including haematoma with/without evolution to fat necrosis, scarring or seroma(2–14.4%), infection ± abscess formation(4–6%), bruising and pain.2–5 A prospective review was performed to evaluate complication rates for x-ray guided vacuum assisted biopsies (VAB), x-ray and ultrasound guided vacuum assisted excisions(VAE).

Methodology: Data was collated in the form of a questionnaire for 79 patients (n = 79) who underwent a stereotactic prone or ultrasound breast VAB or VAE between February-June 2022; including bruising, haematoma and infection. Additionally a subjective pain score was recorded (1–10) immediately after the biopsy (post-biopsy) and on follow-up appointment 7–14 days post biopsy (follow-up).

Results: The majority of patients experienced no pain (27/79) or mild pain (24/79) with 34% and 44% recording a pain scale of 0 (post-biopsy and at follow-up respectively). On follow-up 68% (n = 52) of patients exhibited bruising and 25% (n = 19) haematoma formation. No patients presented with infection. Data for 9G VAB with 12 cores (n = 51) was further analysed, no correlation was demonstrated between pain score and haematoma formation based on breast density (A-D) and lesion location.

Conclusion: Post procedural haematoma formation and pain scores are higher than desirable relative to international literature.6 Implementation of post procedural compression for 10 min with the intention to reassess haematoma rates in 6 months. Infection rates are comparable to recent literature.

Mahoney MC, Newell MS. Jul 1 2013. Breast Intervention: How I Do It. https://doi.org/10.1148/radiol.13120985 . RSNA. Radiology Vol. 268, No. 1

Chetlen AL, Kasales C, Mack J, Schetter S, Zhu J. Hematoma formation during breast core needle biopsy in women taking antithrombotic therapy. AJR Am J Roentgenol. 2013 Jul;201(1):215–22. https://doi.org/10.2214/AJR.12.9930 . PMID: 23789678.

Somerville P, Seifert PJ, Destounis SV, Murphy PF, Young W. Anticoagulation and bleeding risk after core needle biopsy. AJR Am J Roentgenol. 2008 Oct;191(4):1194–7. https://doi.org/10.2214/AJR.07.3537 . PMID: 18806164.

Bick U, Trimboli RM, Athanasiou A, Balleyguier C, Baltzer PAT, Bernathova M, Borbély K, et al.; European Society of Breast Imaging (EUSOBI), with language review by Europa Donna–The European Breast Cancer Coalition. Image-guided breast biopsy and localisation: recommendations for information to women and referring physicians by the European Society of Breast Imaging. Insights Imaging. 2020 Feb 5;11(1):12. https://doi.org/10.1186/s13244-019-0803-x . PMID: 32025985; PMCID: PMC7002629.

AH Lee (2021) G150. Guidelines for non-operative diagnostic procedures and reporting in breast cancer screening. Royal College of Pathologists

Fang M, Liu G. Feasibility and safety of image-guided vacuum-assisted breast biopsy: A PRISMA-compliant systematic review and meta-analysis of 20 000 population from 36 longitudinal studies. Int Wound J 2019; 16 (6):1506–1512

P29 In the context of a benign or normal ultrasound biopsy result, what prompts repeat biopsy to prove benignity?

Laura ward; delara khodabakhshi ; elizabeth o'flynn; lisanne khoo, st george's hospital, correspondence : delara khodabakhshi.

Breast Cancer Research 2023, 25 (Suppl 2) :P29

Background: NHS Breast Screening Programme (NHSBSP) guidance recommends repeat biopsy if a result is equivocal (1), although ‘equivocal’ is not defined. Practice regarding re-biopsy for lesions yielding B1, B1/2 and B2 (i.e. benign/normal) pathology is therefore variable.

Objectives: Determine the re-biopsy rate for lesions biopsied under ultrasound with a benign/normal result. Assess the patient and imaging factors influencing the decision to re-biopsy vs accepting the benign/normal result and review final pathology.

Methods: Ultrasound guided biopsies from a 1- year period from a single screening/symptomatic unit, yielding benign/normal outcomes, were retrospectively obtained from the Pathology database. Screening vs symptomatic, age, M/U grade, lesion size and reported needle position relative to lesion were obtained from the Picture Archiving Service, Radiology Information Service, NHSBSP database and Breast Screening clinic notes.

Results: 765 biopsies were benign/normal. Of these, 46 (6%) underwent a re-biopsy, with rates of 9.8% (24/245) in screening and 4.2% (22/520) in symptomatic. Likelihood of re-biopsy increased with higher M and U gradings and with lower B grading (Tables 1 & 2 ). 14 high M/U grade lesions did not undergo re-biopsy under ultrasound. These cases were reviewed. Patient age, lesion size and documentation of needle position did not affect decision to re-biopsy.

Of the 46 repeat biopsies, 6 yielded B1 (13%), 10 B1/B2 (21.7%), 28 B2 (60.9%), 1 B3 (2.2%) and 1 yielded B5b (2.2%).

Conclusions: This study has highlighted the importance of radiological and pathological concordance in determining whether a re-biopsy is required and the key role therefore of the MDM in reaching these decisions.

NHS BSP Publication no 49: Clinical Guidance for Breast Cancer Screening Assessment. Fourth edition, 15th November 2016

P30 B3 lesions managed with vacuum assisted excision (VAE): Are 12 × 7G cores equivalent to 4 g of tissue?

Rebecca watson; chin lian ng; mags akigbogun; joan butt; vaishali gada ; rosie browning; ozan asmakutlu; vivian chiu; briony bishop, buckinghamshire nhs trust, correspondence : vaishali gada.

Breast Cancer Research 2023, 25 (Suppl 2) :P30

Purpose/Objectives: NHS Breast Screening Programme (NHSBSP) Publication 49 1 states that following a diagnosis of a B3 lesion vacuum assisted excision (VAE) is the procedure of choice to excise approximately 4 g (12 × 7G) of breast tissue for further evaluation. The breast imaging team wanted to assess whether 12 × 7G full notch cores yielded 4 g of tissue.

Methods: A prospective audit was undertaken of consecutive VAE cases, performed under ultrasound or stereotactic guidance from both NHSBSP and two week wait symptomatic sources over a 12 month period. Tissue samples retrieved were weighed and the number of core samples and needle gauge was recorded. For ultrasound guided procedures extent of lesion excision was documented. Post VAE histology was reviewed and compared to the histology yielding a B3 diagnosis.

Results: A total of 59 cases were recorded, 32 ultrasound guided and 27 under stereotactic guidance. There was a greater variation of cores obtained under ultrasound guidance thus a wider specimen weight range averaging 3.6 g. A minimum of 12 cores were always obtained for stereotactic guided procedures eliciting an average of 5 g.

Conclusions: Ultrasound guided VAE’s were performed for complete lesion excision and in some cases this was achieved in less than 12 cores, thus lowering the average specimen weight. A minimum of 4 g of tissue was consistently yielded from 12 × 7G conforming to current guidance.

Public Health England. NHS Breast Screening Programme: Clinical guidelines for breast cancer screening assessment. NHSBSP publication number 49 [Internet]. 2016 [cited 2023 Jan 10]. Available from: Clinical guidance for breast cancer screening assessment (publishing.service.gov.uk)

P31 Evaluating the effectiveness of a breast abscess pathway at a South West London NHS tertiary centre

Abhinav jha ; sharon koo; karis mcfeely; shahrooz mohammadi, st george's university hospital, london, correspondence : abhinav jha.

Breast Cancer Research 2023, 25 (Suppl 2) :P31

Introduction : Breast abscesses are a common breast pathology presenting to the emergency department (ED). A breast abscess pathway was implemented at this London NHS tertiary centre in September 2019 to facilitate imaging of suspected abscesses from ED. We audited referrals and patient outcomes to improve workflow and use of radiology resources.

Method : Retrospective audit of all breast abscess pathway referrals from September 2019 to September 2022. Radiology/clinical documentation on Powerchart and PACS was reviewed by two radiology trainees. Presenting symptoms, antibiotic prescribing, referral documentation, imaging and clinical outcomes were documented on Excel.

Results : 284 patients were referred, excluding 7 due to incomplete documentation.

200 (70%) patients were correctly referred with signs of abscess, 24 (8%) patients were referred with no documented clinical findings of abscess, and 60 (22%) partially fulfilled the referral criteria. 72 (36%), 0 and 8 (13%) had an abscess on imaging respectively.

Of the 25 (9%) of patients not on antibiotics at the time of imaging, 2 (10%) had abscess on imaging versus 76 (30%) of the 256 patients on antibiotics.

63 (79%) patients with abscess underwent ultrasound guided aspiration. 94 (34%) and 21(7%) had ultrasound guided and surgical procedures respectively. 4 (1%) had inflammatory cancers.

Discussion : 30% of referrals are inappropriately completed. Imaging findings of abscess are higher with appropriate referrals, and patients on antibiotics. Most abscesses required aspiration.

Compliance can be improved by ED teaching, and imaging request checklists. This will streamline patient care and use of radiology resources.

https://cks.nice.org.uk/topics/mastitis-breast-abscess/background-information/prevalence/

P32 Breast ultrasound imaging in adult male patients presenting at a London NHS tertiary centre

Abhinav jha ; isabel cornell; sarah mcwilliams.

Breast Cancer Research 2023, 25 (Suppl 2) :P32

Male breast masses are uncommon, with detection often surprising for patients and clinicians. The clinician’s understanding of imaging features of normal, common benign, and rarer malignant findings is crucial. All patients at our institution undergo a triple assessment with clinical history and examination and ultrasound initially. Mammography is a useful troubleshooting tool to downgrade gynaecomastia which is indeterminate on ultrasound. Core biopsies are performed on indeterminate lesions and lesions with sinister features.

We reviewed adult breast ultrasound at our institution in the year 2022. Male breast ultrasound formed a small number (4%) of all breast ultrasound conducted, with the most common indication being gynaecomastia. The majority of examinations (97%) revealed U2 findings, with the majority being gynaecomastia (65%). Other U2, U1 and U5 findings comprised 18%, 14% and 3% respectively.

We discuss tools for the recognition and differentiation on ultrasound of gynaecomastia and its nodular, dendritic and diffuse patterns; mastitis and breast abscesses; lipomas; primary breast and metastatic malignancies; axillary pathologies; fibroadenomas and pathologies more commonly encountered in female patients. We also discuss how mammography can aid in downgrading gynaecomastia with indeterminate findings to avoid unnecessary core biopsy. Finally, core biopsy should be used for indeterminate and more sinister lesions.

Whilst the majority of breast ultrasound examinations in the male breast show gynaecomastia, it is crucial to diagnose this in indeterminate cases to avoid core biopsies, with mammography a key tool for this. Furthermore, it is important to recognise other benign findings, and critically the rare malignancies.

P33 CT detected breast lesions. What to do and how to report them

Maria carrillo ; farah sadrudin.

Breast Cancer Research 2023, 25 (Suppl 2) :P33

Objective: In the past 10 years there has been an exponential use on CT resulting in the identification of incidental breast lesions. Due to its good contrast resolution and larger field of view than mammography breast lesions can be easily detected.

Aim: To familiarize Radiologist and Radiographers with the appearances of benign and malignant breast lesions depicted by CT.

Method: Through this poster we will show cases of beging, indeterminate and suspicious lesions on CT, post operative changes and differentiation with recurrence and some incidental findings on PET CT.

Results: After reading this poster there will be clarity on how to interpret incidental Breast lesions, how to manage them and how to report them appropriately.

Harish M, Konda S, MacMahon H, Newstead G. Breast Lesions Incidentally Detected with CT: What the General Radiologist Needs to Know. Radiographics 2007; Octo 27 Suppl 1: S37–51

Saeedan M, Mobara M, Arafah M,Mohammed T. Breast lesions on chest computed tomography: pictorial review with mammography and ultrasound correlation Curr Probl Diagn Radiol. 2015 Mar-Apr;44 (2):144–54.

Georgieva M, Rennert J, Brochhausen C, Stroszczynski C, Jun E. Suspicious breast lesions incidentally detected on chest computer tomography with histopathological correlation. Breast J. 2021;27:715–722.

Kim S, Park J. Computed tomography of the breast. Abnormal findings with mammographic and sonographic correlation. J Comput Assist Tomogr 2003 Sep-Oct;27(5):761–70.

P34 Correlation of clinical examination, MRI, ultrasound and mammography with pathological sizes

Mei chan chin 1 ; sarah al-ani 2 ; karen gray 1, 1 nhs lanarkshire; 2 nhs greater glasgow and clyde, correspondence : mei chan chin.

Breast Cancer Research 2023, 25 (Suppl 2) :P34

Objective: To determine how accurately the different radiological modalities and clinical examination correlated with true tumour size.

Methods: 96 MRI breasts with contrast performed between January 2019 and October 2020 which had preceding breast ultrasound and mammograms were obtained. PACS and Clinical Portal were used to obtain the relevant measurements.

Reported pathological sizes were presumed to be true tumour sizes. Where available, the clinical examination measurements and reported radiological measurements were obtained. We excluded any entries which did not yield malignancies with comparable measurements. We employed the Pearson correlation coefficient to determine how well clinical examination and each of the different modalities correlated with the pathological measurements.

Results: 41 patients with 42 tumours had reported pathological sizes post-surgical excision. There were 41 correlating available ultrasound, 39 MRI and 24 mammographic measurements. There were only 18 correlating clinical examination measurements. Average tumour size was 29.3 mm. The distribution of malignancy types were 20 lobular, 17 ductal, 4 mixed lobular and ductal and 1 mucinous in our sample. Our results were that MRI correlated the strongest with pathological size at 93%. Mammogram, ultrasound and clinical examination correlation with pathology tumour size were lower at 84%, 70% and 69% respectively.

Conclusion: Our sample mirrors that of published literature which indicate that MRI is more accurate than mammography or ultrasound at predicting pathologic tumour size. In our sample, ultrasound has the lowest correlation with true tumour size probably because of the relatively high number of lobular cancers which are known to be morphologically more diffuse, less-circumscribed and hence more difficult to measure.

Hieken TJ, Harrison J, Herreros J, et al. Correlating sonography, mammography, and pathology in the assessment of breast cancer size. Am J Surg 2001;182:351–4.

Lehman CD, Gatsonis C, Kuhl CK, et al. MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. N Engl J Med 2007;356:1295–303.

Boetes C, Mus RD, Holland R, et al. Breast tumors: comparative accuracy of MR imaging relative to mammography and US for determining extent. Radiology 1995; 197 :743–747.

Leddy R, Irshad A, Metcalfe A, et al. Comparative accuracy of preoperative tumor size assessment on mammography, sonography, and MRI: Is the accuracy affected by breast density or cancer subtype? J Clin Ultrasound 2016;44:17–25.

Madjar H, Ladner HA, Sauerbrei W, et al. Preoperative staging of breast cancer by palpation, mammography and high-resolution ultrasound. Ultrasound Obstet Gynecol 1993;3:185–90.

Davis PL, Staiger MJ, Harris KB, et al. Breast cancer measurements with magnetic resonance imaging, ultrasonography, and mammography. Breast Cancer Res Treat 1996; 37 :1–9.

Pritt B, Ashikaga T, Oppenhemier RG, et al. Influence of breast cancer histology on the relationship between ultrasound and pathology tumor size measurements. Modern Pathology 2004; 905–910

P35 Implementation of preoperative upfront magnetic seed (magseed) localization for impalpable screen detected breast cancer

Vrinda sukumaran ; zoe goldthorpe, somerset nhs foundation trust, correspondence : vrinda sukumaran.

Breast Cancer Research 2023, 25 (Suppl 2) :P35

Background: Magseed is an effective non-inferior alternative to wire guided localisation of impalpable breast lesions. The aim of this audit was to evaluate the effectiveness in placing Magseed at the time of biopsy in screen detected breast lesions.

Methods: An audit was undertaken of a prospectively maintained database of patients who attended assessment for screen detected breast lesions. Patients were selected for upfront Magseed localisation based on a protocol that defined parameters including breast density, radiological features, size and nodal status. Magseed was placed under Ultrasound guidance during their initial visit to the assessment clinic. Data was collected on biopsy findings, MDT outcome and final surgical pathology.

Results: A total of 20 patients were identified and audited against the criteria set out in the protocol.

All lesions in which Magseed was placed were shown to be biopsy proven malignancy. Invasive ductal carcinoma being the predominant pathology (85%). Of the 3 lesions diagnosed as lobular carcinoma no disruption to their diagnostic pathway or surgical pathology were found.

Conclusions: Upfront Magseed localisation is a safe, easy procedure and may improve workflow for radiology services under pressure.

Zacharioudakis, K. (2019, November 1). Is the future magnetic? Magseed localisation for non palpable breast cancer. A multi-centre non randomised control study . European Journal of Surgical Oncology. https://www.ejso.com/article/S0748-7983(19)30529-3/fulltext

Overview | Magseed for locating impalpable breast cancer lesions | Advice | NICE . (2020, November 17). https://www.nice.org.uk/advice/mib236

Thekkinkattil,D.(2019, September 25). A prospective,single-arm,multicentre clinical evaluation of anew localisation technique using non-radioactive magseeds for surgery of clinically occult breast lesions. https://doi.org/10.1016/j.crad.2019.08.018

P36 Imaging of male breast disease—a pictorial review demonstrating a spectrum of male breast disease with radio-pathological correlation

Joan butt; ozan asmakutlu; rosie browning; vivian chiu; vaishali gada ; chin lian ng; rebecca watson, bucks breast unit.

Breast Cancer Research 2023, 25 (Suppl 2) :P36

The male breast can be affected by a wide range of conditions. Most cases of male patients presenting with breast lumps are due to benign causes—only 1% of cases are due to a malignant process 1 . Breast lobular development is not common in men; therefore, breast conditions related to lobular proliferation, such as fibroadenoma and invasive lobular carcinoma are extremely rare in men 2 .

Correct interpretation of imaging findings can guide clinical management by differentiating between benign and malignant processes and is critical because it alleviates patient anxiety and can avoid unnecessary procedures 2 .

The poster is a pictorial review including a variety of interesting male breast conditions which have all presented at a 2WW breast clinic within a district general hospital over a four-year period. Cases range from the benign pathologies of breast abscess and gynaecomastia to various malignant cases of invasive and non-invasive breast cancer. A very rare and unusual case of a metastatic deposit of oesophageal origin presenting as a lump within the breast will also be presented 3,4 .

A broad range of imaging modalities are included ranging from mammography and ultrasound to CT and MRI.

Clinical findings and key imaging features will be shown along with pathological correlation, demonstrating the importance of robust triple assessment in the accurate diagnosis of male breast disease.

Chesebro, A. Male Breast Disease: What the Radiologist needs to know. Curr Probl Diagn Radiol. 2019 Sep-Oct;48(5):482–493.Available from: https://doi.org/10.1067/j.cpradiol.2018.07.003 . Epub 2018 Jul 29

Viana, M. Imaging of male breast disease: the good, the bad and the ugly – A pictorial Review. Breast Imaging. 2020 December 1; Volume 68: P45–56. Available from: https://doi.org/10.1016/j.clinimag.2020.06.025

Genç, B. Metastasis to the Male Breast from Squamous Cell Lung Carcinoma. Case Reports in Oncological Medicine Volume 2013, Article ID 593970, 4 pages. Available from: http://dx.doi.org/10.1155/2013/593970

Wu, S-G, Zhang. Sites of metastasis and overall survival in esophageal cancer: a population-based study. Cancer Manag Res.2017; 9: 781–788. Published online 2017 Dec 6. Available from: https://doi.org/10.2147/CMAR.S150350

P37 Managing anxiety in mammography: The client and the practitioner

Johanna mercer 1 ; claire mercer 2, 1 vita health group: newcastle; 2 university of salford, correspondence : claire mercer.

Breast Cancer Research 2023, 25 (Suppl 2) :P37

Background: Being responsible for providing the best possible care to those attending mammography and promoting wellbeing is important (1). Anxiety plays a large role in maintaining negative well-being; an emotion individuals experience when they are worried, afraid, or tense (2).

Client anxiety contributes to factors such as pain (3–5) and reattendance rates (6–8). Educating practitioners in client wellbeing, utilising strategies to enforce this in practice, can ensure they are providing good care whilst improving wellbeing, attendance rates and a reduction in pain.

Practitioner wellbeing is equally important. Low wellbeing can lead to staff sickness (9), increasing NHS cost, and is also correlated with medical errors and decreased patient safety (10). Educating practitioners on strategies to manage anxiety, whilst adapting the workplace to help reduce anxiety, can aid in improving practitioner wellbeing and reducing sickness and errors.

Methods: To identify and explain the common causes of anxiety in clients and practitioners, and demonstrate knowledge to implement solutions for reducing client and practitioner anxiety.

Results: Incorporating relaxation techniques and procedural knowledge into client leaflets, improving practitioner communication, and adapting the mammography environment can help reduce client anxiety and increase attendance rates. For practitioners, using mindfulness and stress management techniques, communicating regularly with peers and managers, and having access to a serenity room can help reduce anxiety.

Conclusions: A focus on anxiety management can have positive benefits to both staff and clients within mammography services.

Public Health England. Guidance for breast screening mammographers . Available from: https://www.gov.uk/government/publications/breast-screening-quality-assurance-for-mammography-and-radiography/guidance-for-breast-screening-mammographers . [Accessed 15th August 2021].

Department of Health. The relationship between wellbeing and health . Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/295474/The_relationship_between_wellbeing_and_health.pdf . [Accessed 10th August 2021].

Brunton M, Jordan C, Campbell I. Anxiety before, during, and after participation in a population-based screening mammography programme in Waikato Province, New Zealand. NZMJ. 2005;118(1209):1–10.

Jackson V. Pain psychology: An overview of concepts and methods. In: Hogans BB, Barreveld AM. (eds.). Pain care essentials . USA: Oxford University Press; 2019. p. 75–89.

Maimone S, Morozov AP, Wilhelm A, Robrahn I, Whitcomb TD, Lin KY, Maxwell RW. Understanding patient anxiety and pain during initial image-guided breast biopsy. Journal of Breast Imaging. 2020 Nov;2(6):583–89.

Aro AR, De Koning HJ, Absetz P, Schreck M. Two distinct groups of non-attenders in an organized mammography screening program. Breast Cancer Research and Treatment. 2001 Nov;70(2):145–53.

Consedine NS, Magai C, Krivoshekova YS, Ryzewicz L, Neugut AI. Fear, anxiety, worry, and breast cancer screening behavior: a critical review. Cancer Epidemiology and Prevention Biomarkers. 2004 Apr 1;13(4):501–10.

Lagerlund M. Factors affecting attendance at population-based mammography screening. Department of Medical Epidemiology and Biostatistics; 2002.

Montgomery M, McCrone SH. Psychological distress associated with the diagnostic phase for suspected breast cancer: systematic review. Journal of Advanced Nursing. 2010 Nov;66(11):2372–90.

Hu W, Wang G, Huang D, Sui M, Xu Y. Cancer immunotherapy based on natural killer cells: current progress and new opportunities. Frontiers in Immunology. 2019 May 31;10(1):1205.

P38 Compress with me

Uju olakunle, doncaster and bassetlaw teaching hospitals nhs foundation trust, correspondence : uju olakunle.

Breast Cancer Research 2023, 25 (Suppl 2) :P38

Background: Compress with me technique has shown to be a technique that could reduce compression pain and anxiety experienced by patients during mammography examination. The discomfort of the mammographic examination can be linked to the decision to attend for screening. Therefore, interventions to reduce the discomfort caused by the mammogram are key to improve women’s adherence, whilst assuring the technical quality of the image1. This study aims to evaluate the value of targeted communication (Mammographer-patient interaction) during compression in mammography (especially in women whose breasts are particularly sensitive) and its effect in the improvement of low uptake of screening appointments.

Method: Data was collected from two clinical training centres between April to July 2022, using non-probability, convenience sampling method. Questionnaire was administered before the examination to 296 mammogram patients. Participants were women aged 50 to 75 years, without a history of recent breast surgical procedure or treatment, and who could perform breast self-examination. After positioning the patient, using the foot pedal, the compression was brought down until 35N, then the mammographer together with the patient manually completes the compression.

Results: 78% (230.88/296) of the women preferred the compress with me technique over the foot pedal controlled compression technique due to reduced pain and anxiety, 14% (41.44/296) still felt pain and discomfort but due to other various reasons, whilst 8% (23.68/296) felt indifferent about the technique.

Conclusion: Results suggest that under the same amount of compression force, compress with me technique gave much reduced pain and anxiety compared to foot pedal compression.

Perez-Leon D, Posso M, Louro J, Ejarque B, Arranz M, Arenas N, Maiques J, Martínez J, Maciá F, Román M, Rodríguez-Arana A, Castells X, Alcántara R. Does the patient-assisted compression mode affect the mammography quality? A within-woman randomized controlled trial. Eur Radiol. 2022 Nov; 32(11):7470–7479. https://doi.org/10.1007/s00330-022-08834-z . Epub 2022 May 10. PMID: 35536391

P39 Trends in equipment faults, downtime, and cancellations in the UK breast screening programmes

John loveland ; alistair mackenzie, correspondence : john loveland.

Breast Cancer Research 2023, 25 (Suppl 2) :P39

Background: To evaluate trends with time for x-ray fault rates, downtime, and equipment related cancellations in breast screening.

Methods: The National Coordinating Centre for Physics in Mammography (NCCPM) has created and maintained a database of mammography equipment faults for more than 30 years. Data were analysed over the period 1993 to 2021.

Results: The number of faults reported per x-ray set has increased from about 1.1 to a peak of 4.4 faults/unit but average downtime per fault has remained stable. Total downtime has increased from around 250 days to a peak of 1400 days. Average age of screening equipment has also increased but despite a proven link between age and fault rate this does not fully explain the change.

Digital systems have a higher fault rate than film-screen systems t(8) = 6.76, p < 0.001 and this difference is independent of equipment age. Most fault types have remained relatively constant over time such as cracked paddles but new faults such as software faults have risen rapidly over the last 15 years. This suggests that the increased number of faults are not due to better reporting rates.

Conclusions: From the fault database, we have been able to show trends in faults and their effect on the screening programme. It has proven to be a useful tool and has had important implications for planning in the UK breast screening programmes.

Stuffins M, Loveland J, Halling-Brown M, Mackenzie A. The relationship between age of digital mammography systems and number of reported faults and downtime. Phys Med. 2022 Jun;98:113–121. https://doi.org/10.1016/j.ejmp.2022.04.015 . Epub 2022 May 6. PMID: 35526372.

P40 A service evaluation of a symptomatic breast one-stop clinic

Devakie sookdeo, university college london hospital and kingston university, correspondence : devakie sookdeo.

Breast Cancer Research 2023, 25 (Suppl 2) :P40

Background: 60% of women diagnosed with breast cancer present symptomatically via One-Stop Clinics (OSCs) 1 . OSCs facilitate a two-week wait referral-to-diagnosis pathway which utilises triple assessment (TA) to ensure 97% accuracy of non-operative diagnosis 2 . OSCs have been repeatedly reviewed to improve access for urgent referrals 3 .

Aim: Perform a service evaluation of a symptomatic breast OSC evaluating: structure, process, and output.

Methodology: A cross-sectional, cohort design, using quantitative, retrospective data from a convenience sample of 1157 patients attending a Central London NHS Hospital, over four-months (September-December 2019 and Tuesdays in May 2020). Permission from the Clinical Governance Committee was obtained. Data from EPIC and Carestream Vue PACS were recorded anonymously in a Microsoft Excel spreadsheet, including:

Structure: compared three OSCs: routine (SOSC) (single-radiologist), double-OSC (DOSC) (double clinic and radiologists) and Covid-OSC (COSC) (triaged appointments) to assess appointment capacity, time-efficiency, and workflow.

Process: assessed use of resources [digital breast tomosynthesis (DBT), needle-tests].

Output: evaluated the impact of triaging referrals versus outcomes.

Results: 104 appointment weekly capacity across 77 OSCs were assessed.

1125(97%) patients completed TA appointments within two visits. 923(80%) received same-day diagnosis.

162(14%) of 992(86%) TA patients followed radiology-led discharge pathway which saved average 51-min per appointment.

Average appointment was 140-min (8–360-min). Average waiting time for surgical consult was 39-min, and ultrasound 42–51 min.

52/85 DBTs downgraded mammograms. 4/85 were upgraded.

DBT prevented 80% overdiagnosis and could save average 27–52 min per appointment.

95(10%) patients experienced diagnostic delays (1–55 days). 59% due to radiology time constraints, 12% patient choice.

557(48%) referrals required GP management, 344(30%) were non-urgent.

Conclusion: This unit met OSC capacity demands and diagnostic targets.

Ramzi, S. and Cant, P. J. (2021) ‘Comparison of the urgent referral for suspected breast cancer process with patient age and a predictive multivariable model’, British Journal of Surgery Open, 5(2). https://doi.org/10.1093/bjsopen/zraa023 .

Batt, J., Ainsworth, R., Rayter, Z., Nickells, J. and Valencia, A. (2021) ‘Sensitivity and missed cancer rate in the symptomatic breast clinic—A retrospective cohort study of 40 323 patients’, The Breast Journal , 27(3), pp. 248–251. https://doi.org/10.1111/tbj.14134 .

Rao, A., Razzaq, H., Panamarenko, B., Bottle, A., Majeed, A. and Gray, E. (2021) ‘Online application for self-referral of the patients with breast symptoms’, Annals of Medicine and Surgery, 66(2021), pp. 102372. https://doi.org/10.1016/j.amsu.2021.102372

P42 Over 70 self-referral screening outcomes to Belfast breast screening unit—a retrospective study 2015- 2022

Jenny frazer, belfast health and social care trust, correspondence : jenny frazer.

Breast Cancer Research 2023, 25 (Suppl 2) :P42

Introduction: The Breast Screening Propgramme (BSP) invites clients up to age 70, after 70 clients can self refer. As a region Northern Ireland give cards/leaflets to clients, who attend their last invited mammogram, to promote self referral in 3 years time.

Aim: Examine extent ≥ 70 women self-refer in Belfast Trust during an eight-year period and study the screening outcomes in these women.

Method: Retrospective review of NHS Breast Cancer Screening Database (NBSS) crystal report and KC62 looking at self-referral appointments, recalls to assessment clinic and resultant cancer diagnoses in women over 70 years in Belfast Trust between 31st March 2015 and 1stApril 2022. Analysed resultant diagnosis to determine tumor grade, lymph node and hormone status on surgical specimen pathology report on Northern Ireland electronic care record (NIECR).

Result: Over this 8-year time period, the total number of invitations for ≥ 70 years old was 5926 of these 4544 clients attended, DNA rate of 1382 (23.3%). The clients recalled to assessment were 197 (4.3%) with a cancer detection rate of 23.3 per 1000) and Invasive cancer detection rate of 18.9 per 1000. The average whole tumor size detected was 19.64 mm with a range of 0.8–96 mm. The tumor grade is known for 75 out of 86 invasive cancers, The most common tumor grade is grade 2, most common hormone status ER positive (66/80, 82.5%)PR positive (54/80, 67.5%) Her-2 negative (70/80, 87.5%).

Conclusion: Approx 2.5% of screening women self-refer in the Belfast unit, proportionately higher number of over 70 women are recalled to assessment and subsequent increased cancer detection rates ≥ 70 years. Does the self referal policy of the NHSBSP cause finical and capacity burden on the screening units.

Chandler, A. P., Davies, L., Gower-Thomas, K., Lewis, H., & Dillon, M. (2019). P031. Patterns of self-referral for breast cancer screening in women aged over 70 in Wales between 2005 and 2016. European Journal of Surgical Oncology , 45 (5), 894. https://doi.org/10.1016/j.ejso.2019.01.053

P43 A retrospective study to evaluate multiple biopsies of microcalcifications identified on screening mammography

Kerrie power ; laura foster; mohamad hajaj; robert dickens, inhealth jarvis, correspondence : kerrie power.

Breast Cancer Research 2023, 25 (Suppl 2) :P43

Background: Recall for breast screening assessment can be associated with significant client anxiety (1, p. 8). This anxiety can be further increased by undergoing biopsy. As with any interventional procedure, the risks include but are not limited to (2):

Haematoma formation

This study aims to determine if multiple biopsies for potentially abnormal calcifications can be reduced, whilst maintaining high cancer detection. If possible, this would reduce unnecessary biopsy and client anxiety, as well as alleviate the workload pressure on the breast screening service.

The NHSBSP (3, p. 28) recommends that practice should be reviewed and that groups of interest are the last 20 clients who have had more than one biopsy procedure and also the last 20 clients who have had a benign result.

Methods: This retrospective study will investigate screening clients assessed between August 2021 and August 2022 who have undergone multiple x-ray guided biopsies for calcifications. For improved representativeness, a year’s worth of data was selected rather than the last 20 clients. The period selected is contemporary enough to be relevant but allows for final results for clients who have gone on to have further treatment.

A mixture of data regarding recall to assessment, biopsy method, results and MDM discussion is being gathered from MDM notes, assessment paperwork, NBSS and PACS.

No ethics considerations are required as no client identifiers will be used.

Results will be available by May 2023.

NHSBSP. Clinical Guidance for Breast Cancer Screening Assessment. [Internet]. 2016 [cited 10 Jan 2023]. Available from: Clinical guidance for breast cancer screening assessment (publishing.service.gov.uk)

Cancer Research UK. Vacuum assisted biopsy. [Internet] 2020. [cited 10 Jan 2023]. Available from: https://www.cancerresearchuk.org/about-cancer/breast-cancer/getting-diagnosed/tests-diagnose/vacuum-assisted-biopsy

Quality Assurance Guidelines for Breast Cancer Screening Radiology. [Internet.] 2011 [cited 10 Jan 2023]. Available from:  Colposcopy and Programme Management (publishing.service.gov.uk)

P44 Is there a relationship between breast density and interval cancers? A clinical audit

Kirsty whitaker; emily nightingale, rotherham nhs foundation trust, correspondence : emily nightingale.

Breast Cancer Research 2023, 25 (Suppl 2) :P44

Background: Interval cancers, cancers diagnosed between screening rounds, are associated with poorer outcomes than screen detected cancers. 1,2 Interval cancers are commonly diagnosed in patients with greater breast density. 2 These patients are at greater risk of developing cancers; there is also the potential for dense breast tissue to mask cancers on mammograms. 2

Breast density is an international talking point for patients, policy-makers, and staff, particularly in the USA with many states requiring women to be notified regarding their breast density. 3 In response to this and more patients querying their breast density at our Trust, we were inspired to undertake this audit.

Method: A retrospective audit of interval cancers diagnosed between 1st April 2017 and 31st March 2020 was completed.

113 interval cancers were identified using CREGX Cancer Registry Extract data on NBSS.

Cases were reviewed by a Reporting Radiographer and categorised as ‘dense’, ‘mixed’, or ‘fatty’ breast tissue.

Interval cancers were reviewed and graded as either category 1 (normal/benign) 4 , category 2 (difficult to perceive) 4 , category 3 (obviously malignant) 4 by consultants.

Results: Of the 113 interval cancers identified:

95/113 (84%) had mixed or dense breast tissue.

74/89 (83%) graded category 1 had mixed/dense breast tissue.

21/24 (87.5%) graded category 2 had mixed/dense breast tissue.

Conclusions: From the cases reviewed a significant percentage had mixed/dense breast tissue, with only 16% of interval cancers having fatty breast tissue. The majority of category 2 interval cancers had mixed/dense breast tissue, which could potentially have masked a subtle cancer on the screening mammogram.

Strand, F. Azavedo, E. Hellgren, R. et al. (2019) Localized mammographic density is associated with interval cancer and large breast cancer: a nested case–control study. Available at: https://doi.org/10.1186/s13058-019-1099-y (Accessed: 25th July 2022).

Nguyen, T. L. Li, S. Dite, G. S. et al . (2020) ‘Interval breast cancer risk associations with breast density, family history and breast tissue aging’, International Journal of Cancer , 147 (2), pp. 375–382. Available at: https://onlinelibrary.wiley.com/doi/full/10.1002/ijc.32731 (Accessed: 25th July 2022).

Guterbock, T. M. Cohn, W. F. Rexrode, D. L. et al . (2017) ‘What Do Women Know About Breast Density? Results From a Population Survey of Virginia Women’ . Journal of the American College of Radiology, 14 (1), pp. 34–44. Available at https://www.sciencedirect.com/science/article/pii/S154614401630583X (Accessed 26th July 2022).

Public Health England. Breast Screening: reporting, classification and monitoring of interval cancers and cancers following previous assessment [Internet]. GOV.UK; 2021 [updated 2021 February 25; cited 2022 November 25]. Available from: https://www.gov.uk/government/publications/breast-screening-interval-cancers/breast-screening-reporting-classification-and-monitoring-of-interval-cancers-and-cancers-following-previous-assessment

P45 Implementing tomosynthesis for routing breast cancer screening in England—cost implications of equipment upgrade/replacement

Huajie jin 1 ; kang wang 1 ; john loveland 2 ; alistair mackenzie 2 ; stephen duffy 3 ; michael michell 4, 1 king's college london; 2 royal surrey nhsn trust; 3 queen mary university of london; 4 king's college hospital nhs foundation trust, correspondence : kang wang.

Breast Cancer Research 2023, 25 (Suppl 2) :P45

Background: Compared with the current standard screening test for breast cancer (2D digital mammography (2DDM)), digital breast tomosynthesis (DBT) is more accurate but might be associated with increased cost. This study aims to assess the cost implications of equipment upgrade/replacement if DBT was used for routine breast cancer screening in England.

Methods: The 10-year cost implications of equipment upgrade/replacement was assessed for two different strategies: (1) No Switch (continue with 2DDM); (2) Gradually Switch (upgrade upgradable screening machines to DBT in Year 2023 and replace unupgradable machines when they expire). Due to a lack of data and resource constrains, only the cost of purchasing/upgrading the machines were included in this analysis. Information about the current screening machines (e.g., number, function, and age) were obtained from the NHSBSP equipment database. The cost of purchase and upgrade of the screening machine were obtained from the NHS Supply Chain.

Results: To implement DBT for all routine breast cancer screening in England, 53 screening machines need be upgraded and 210 need to be replaced as they are unupgradable. The average age of existing screening machines is 5.4 years (range: 1–13 years). The discounted 10-year cost of ‘No Switch’ and ‘Gradually Switch’ is £45.7 million and £48.2 million, respectively.

Conclusion: Switching to DBT will increase the cost of equipment upgrade/replacement by 2.6 million; but the increased budget could be potentially offset by savings in diagnostic tests and treatment. Our results can be updated when the long-term cost impacts of using DBT become available.

P46 Siemens' intelligent optimum compression (Opcomp) function—a BHSCT review

Paula hughes ; michelle murphy; christine greene; jessica robinson; noelle clerkin, correspondence : paula hughes.

Breast Cancer Research 2023, 25 (Suppl 2) :P46

Background: Compression is essential to optimum image quality, as it reduces image motion, geometric blur and differentiates between superimposed tissue and breast lesions, whilst reducing patient dose (1,2). Siemens’ Intelligent Optimum compression (Opcomp) function highlights to the Radiographer at the point of proposed optimal compression. This study aims to identify what is the average optimal compression point and if the function coincides with the mammographer’s applied compression selection.

Methods: In one screening session using three Siemens Mammo Inspirations, 61 clients were imaged.

Four trained Mammographers recorded the Newton force applied when undertaking a Right Medial Lateral Oblique (MLO) projection. The compression was also recorded at the point when the Opcomp feature was displayed.

Results: Opcomp feature displayed in 62% of mammograms performed. The mean newton value for the Opcomp to present was at 79N. Final Compression values applied after the Opcomp prompt delivered a variety of results from a reduction of 26N to an increase of 35N. On average the Radiographer applied 8.1N after the Opcomp feature was displayed.

Conclusion: Compression applied by 38% of cases did not meet the manufactures suggested optimum compression point. There is a paucity of information available on the Opcomp feature and how it optimises image quality in practice. In order to set benchmarks and utilise this feature, further investigation is required.

Feder, K. and Grunert, J.H., 2016. Is Individualizing Breast Compression during Mammography useful?-Investigations of pain indications during mammography relating to compression force and surface area of the compressed breast. RoFo: Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin, 189(1), pp.39–48.

Liu, Y.L., Liu, P.Y., Huang, M.L., Hsu, J.T., Han, R.P. and Wu, J., 2017. Simulation of breast compression in mammography using finite element analysis: A preliminary study. Radiation Physics and Chemistry , 140 , pp.295–299.

P47 Does the addition of digital breast tomosynthesis within a departments breast imaging setting contribute to the patients pathway and reduce the benign biopsy rate?

Ann williams, worcester acute nhs trust, correspondence : ann williams.

Breast Cancer Research 2023, 25 (Suppl 2) :P47

Objective: Standard 2D spot compression and magnification are utilised in the workup of any suspicious M3 or M4 lesions seen on imaging. Breast Tomosynthesis was introduced within our service in 2021 to aid with the assessment of these equivocal lesions. This retrospective service evaluation aimed to establish if by the introduction of Digital Breast Tomosynthesis the patients journey can be improved and the benign biopsy rate reduced.

Method: 121 Indeterminate M3 and M4 lesions seen on 2D mammography diagnosed during the 6-month evaluation window on both symptomatic and screening breast patients were retrospectively analysed alongside the subsequent Digital Breast Tomosynthesis views. Data collection included: 2D and 3D image grading, lesion size and lesion features. Data was correlated with image guided biopsy results and surgical outcomes when undertaken. As patients were not able to be followed up as part of the evaluation the histological outcome was deemed the gold standard for analysis. This data was then analysed used both descriptive and inferential analysis to investigate the relationship between the various data recorded.

Results: The evaluation of 121 consecutive patients found that there was a significant reduction in M3 grading on 2D mammography with the addition of the 3D DBT. Out of the 121 patients that were subjected to 3D DBT: 51 were graded as normal, 25 were proven benign at biopsy, 4 were graded as B3 requiring surgery and 41 were proven malignant. In total following DBT only 70 patients went on to have a biopsy reducing the biopsy rate by 42.15%. Features identified on 2D mammography included 60 masses, 29 distortions, 31 asymmetric densities and 1 lymph node. The true positive rate was increased from 3% with 2D imaging to 26% with the combined imaging.

Conclusion: The addition of Digital Breast Tomosynthesis in the unit for the assessment of equivocal M3 and M4 lesions reduced the benign biopsy rate, and aided in the shortening time to diagnosis without compromising the detection of breast cancer. This study highlighted the important of incorporating new imaging technologies into clinical practice to improve patient care and outcomes.

Advances in knowledge: This evaluation has identified the added benefit to a breast imaging service with the addition of 3D DBT. The ongoing use of the modality can reduce the burden on the pathologist’s workload by reducing the benign biopsy rate and improve the patients physical and psychological experience.

P48 The use of the mammography chair in reducing work related musculoskeletal disorders

Iram shabana, correspondence : iram shabana.

Breast Cancer Research 2023, 25 (Suppl 2) :P48

Background: Whilst mammography technology is constantly improving, the technique has remained the same. Although, it is successful in acquiring diagnostic images for breast disease diagnosis, it comes with some difficulties for Mammographers.

Conventional mammography technique requires the mammographer to move into awkward and strenuous positions. Repetitive movements adopted by the mammographer have been associated with work related musculoskeletal disorders (WRMSDs) (1), resulting in long term sickness. In this current climate with a shortage of mammographers, we need to ensure that we are looking after our staff’s wellbeing.

Public Health England’s 2018 publication, ‘Breast screening mammography: ergonomics good practice’ provides guidance for mammographic staff to adopt best practice to avoid or minimise harm from work related injuries (WRIs) (2).

Methods: Difference in stature between the mammographer and patient is one major factor that can cause complications during the procedure which can lead to WRMSDs (3).

This poster will use effective illustrations with annotations to demonstrate the benefits of using the mammography chair to sit patients down whilst performing CC views, allowing for the reduction in WRMSDs. This method works well when using a specialised chair, solely designed to assist in performing mammograms (4).

Conclusion: This poster aims to showcase the benefits of the mammography chair especially for mammographers of shorter stature. It can be used as an educational tool to identify and communicate an improvement in mammography technique. Subsequently, allowing for a change to help avoid or minimise WRIs within mammographic staff, providing a solution to support the government’s guidance (2).

Borrelli CD. Repetitive strain injury – RSI. In: Hogg P, Kelly J, Mercer C, editors. Digital Mammography. Switzerland: Springer; 2015. 195–202.

Cernean N, Serranheira F, Gonçalves P, Sá Dos Reis C. Ergonomic strategies to improve radiographers' posture during mammography activities. Insights Imaging. 2017 Aug;8(4):429–438. https://doi.org/10.1007/s13244-017-0560-7 . Epub 2017 Jun 21. PMID: 28639113; PMCID: PMC5519499.

England PH. Breast screening: Ergonomics in screening mammography [Internet]. GOV.UK. 2018Oct22 [cited 2023Jan13]. Available from: https://www.gov.uk/government/publications/breast-screening-ergonomics-in-screening-mammography

Vela Medical. Vela mammography chair—best conditions for effective examinations [Internet]. VELA Medical. 2022 [cited 2023Jan15]. Available from: https://vela-medical.com/chair/vela-mammography-chair/

P49 Keeping abreast with breast cosmetic surgery and its myriad of appearances on multi-modality imaging

Yee ting sim ; konstantia stavrou; leila ismail; alexandra economacos, mediclinic city hospital & comprehensive cancer centre, dubai, uae, correspondence : yee ting sim.

Breast Cancer Research 2023, 25 (Suppl 2) :P49

Background : We encounter increasing number and variety of breast cosmetic augmentation surgery being offered commercially and conducted on patients, who often have little information as to the technique or material utilised.

Methods : Patients with history of breast cosmetic surgery, including implant augmentation, filler injections, fat transfer, are collated on our database. We reviewed their imaging and selected cases with key learning points, particularly patients who underwent non-conventional imaging techniques such as contrast-enhanced mammography.

Results: Through this pictoral review, we present the spectrum of imaging appearances of the different types of breast augmentation surgery on conventional mammography, ultrasound, MRI through to the newer contrast-enhanced spectral mammography (CESM). Patients who had undergone free silicone injections pose significant challenge in breast screening evaluation; we have used MRI and CESM as alternatives, but these did not achieve additional improvement in diagnostic image quality.

Conclusions : Knowledge of normal radiologic features of the range of breast cosmetic surgery and their common complications is useful in the accurate diagnosis and evaluation of breast conditions.

Raj SD, Karimova EJ, Fishman MDC et al. Imaging of breast implant-associated complications and pathologic conditions: breast imaging. Radiographics 2017; 37 (5): 1603–1604.

Harvey KL, Clark SE. A guide to breast implants for the non-breast specialist. Womens Health (Lond). 2016 Nov;12(6):533–537. https://doi.org/10.1177/1745505716687562 . Epub 2017 Feb 10. PMID: 29334026; PMCID: PMC5373262.

P50 Imaging features of breast abscesses and other inflammatory breast disorders: A pictorial review

Sharon koo; tom hughes; sarah mcwilliams, st george's university hospital, correspondence : sarah mcwilliams.

Breast Cancer Research 2023, 25 (Suppl 2) :P50

Imaging features of breast abscesses, granulomatous mastitis, and inflammatory breast carcinoma will be presented and clinical manifestations, differential diagnoses, and management discussed. Various percutaneous drainage options including use of vacuum drainage will be discussed.

Breast infections and abscesses are a common presentation to the symptomatic clinic. Radiology plays a pivotal role in their diagnoses and management, particularly owing to the move away from conventional approaches of surgical incision and drainage, to more minimally invasive image-guided procedures. Ultrasound is vital in identifying the presence and size of abscesses, guiding radiological intervention, and monitoring progress. Imaging features of infective abscesses can overlap with other more sinister aetiologies such as granulomatous disorders or inflammatory breast carcinoma, making diagnoses challenging. Awareness of their clinical and radiological features is crucial.

Breast abscesses can take on a long clinical course and warrant close monitoring. Radiologists play an essential role in evaluation, follow up and treatment. Prompt drainage reduces the risk of multifocal abscesses and need for surgical intervention, which is challenging in many of these postpartum women. Recognition of inflammatory breast carcinoma is crucial in patients with poor response to antibiotic therapy and warrants biopsy.

P51 A rare cause of breast calcifications

Arlene weir 1 ; lorna duddy 2 ; alissa connors 2, 1 breastcheck southern unit/cork university hospital; 2 breastcheck southern unit, correspondence : arlene weir.

Breast Cancer Research 2023, 25 (Suppl 2) :P51

Background: Breast calcifications are tiny flecks of calcium which are commonly seen on mammography, which have various causes, however ductal carcinoma-in-situ represents 25–30% of all reported breast cancers and 95% of all DCIS is diagnosed because of mammographically detected microcalcifications (1). Accurate evaluation of calcifications is vitally important and characterisation based on morphological features alone may be challenging, with tomosynthesis or stereotatic biopsy frequently being performed. The majority of benign calcifications are due to fibroadenomatoid or fibrocystic change, however there are also other rare and unusual causes.

Material and methods: We retrospectively reviewed the imaging findings and histopathology results of two patients with breast calcifications.

Results: Two patients with indeterminate breast calcifications on mammography without a discrete mass subsequently had tomosynthesis guided biopsies. Histopathology appearances were initially also indeterminate, however further evaluation with congo red staining showed apple green birefrigence under polarized light in keeping with a diagnosis of breast amyloid.

Conclusions: Breast amyloid can be either primary or secondary and is a rare cause of breast calcifications with the first case reported in 1973. Radiographic findings vary but appearances may mimic DCIS or invasive ductal carcinoma. Breast amyloid occurs in < 1% of people with amyloidosis, however 25% of breast amyloid is associated with systemic disease. Primary breast amyloid does not normally progress to systemic disease, however 50% of cases are associated with a haematological disease such as lymphoma and patient's should be referred for haematological work-up.

Smithuis R, Pijnappel R. Differential of breast calcifications [Internet]. The Radiology Assistant: Differential of Breast Calcifications. Radiology department, Rijnland Hospital, Leiderdorp and Martini Ziekenhuis, Groningen, the Netherlands.; [cited 2023Jan15]. Available from: https://radiologyassistant.nl/breast/calcifications/differential-of-breast-calcifications

P52 Male breast diseases: A pictorial overview at a local NHS Trust

Juliet mazarura, university hospitals birmingham nhs trust, correspondence : juliet mazarura.

Breast Cancer Research 2023, 25 (Suppl 2) :P52

Background: Male breast cancer is rare (comprising less than 1% of all breast cancers) whereas gynaecomastia is very common (A Shaaban 2019).

However, there is a range of other male breast disease which is encountered in breast imaging departments. Male breast disease can be distressing for the patient and their relatives with feelings of emasculation, anxiety, depression and embarrassment due to their condition (Kipling et al. 2014).

To raise awareness of common male breast disease, despite different local imaging protocols.

To illustrate radiological features of common breast disease in a pictorial poster so as to ensure effective patient management.

Breast pathology includes : Breast Cancer, DCIS, Gynecomastia, Lipoma/fat necrosis

Benign breast disease (papilloma, sebaceous cysts, haematoma fibroepithelial lesions and abscess (Williams & Metelko 2019.)

Conclusion: Breast imaging practitioners need to be aware of common radiological male breast disease features. Men should be offered a service tailored to their breast imaging needs.

Abeer M.Shaaban Pathology of the male Diagnostic Histopathology Volume 25, Issue 4, April 2019, Pages 138–142 https://www.sciencedirect.com/journal/diagnostic-histopathology

Best practice diagnostic guidelines for patients presenting with breast symptoms. NICE Nov 2010 https://www.evidence.nhs.uk/document?id=2013590&returnUrl=search%3Fq%3Dhc11%26sp%3Don&q=hc11

Mike Kipling 1, Jane E M Ralph 1, Keith Callanan 1Psychological impact of male breast disorders: literature review and survey results Breast Care (Basel) 2014 Feb;9(1):29–33. https://doi.org/10.1159/000358751 .

Male breast ultrasound: 2019 audit results Umit Aksoy Ozcan, Susan Williams, Marie Metelko

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Symposium Mammographicum 2023. Breast Cancer Res 25 (Suppl 2), 122 (2023). https://doi.org/10.1186/s13058-023-01702-8

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Best of the year: Advanced breast cancer in 2023

Ilana schlam.

a Department of Hematology and Oncology, Tufts Medical Center, Boston, MA, USA

b Tufts University, Boston, MA, USA

Mariana Chavez-MacGregor

c Health Services Research Department, The University of Texas, MD Anderson Cancer Center, Houston, TX, USA

d Breast Medical Oncology Department, The University of Texas, MD Anderson Cancer Center, Houston, TX, USA

• • This article reviews some of the most clinically relevant data related to metastatic breast cancer presented during 2023.
• • Elacestrant (oral SERD) was approved in 2023 for the treatment of patients with pretreated ESR1 mutant HR-positive mBC.
• • Capivasertib (AKT inhibitor) was approved in 2023 for patients with pretreated mBC with PIK3CA , PTEN , or AKT1 alterations.
• • Sacituzumab govitecan was approved in 2023 for patients with HR-positive tumors previously tereated with chemotherapy.

In recent years, substantial progress has been made in the development of innovative therapies for advanced breast cancer (BC), and 2023 was no exception. This commentary provides an overview of key advances, including research findings published or presented in 2023, focusing on the most impactful studies that have the potential to reshape clinical practice.

1. Hormone receptor (HR) positive breast cancer

Endocrine therapy (ET) remains the cornerstone of the treatment of patients with metastatic HR-positive BC. For several years, cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) in combination with ET have become part of the standard of care for the treatment of patients with HR-positive advanced BC. Three CDK4/6i, palbociclib, ribociclib, and abemaciclib, are approved for the treatment of advanced HR-positive BC and have been used as first-line treatment. The studies that led to the approval of these agents were powered for a primary endpoint of progression-free survival (PFS), which was very similar across the mentioned trials ( Table-1 ) [ [1] , [2] , [3] ]. Palbociclib did not meet the secondary endpoint of overall survival (OS) and ribociclib did [ [1] , [2] , [3] ]. In 2023, the OS results of the phase III MONARCH 3 study (AI ± abemaciclib) were released and showed a non-statistically significant improvement of 13.1 months in the abemaciclib arm (p = 0.066). The small sample size and the 2:1 randomization could explain this. Moreover, the study was not powered for this secondary endpoint [ 4 ]. Ribociclib and abemaciclib are considered by many the preferred CDK4/6i in the metastatic setting, as they met their prespecified endpoint of PFS and showed at least a numerical benefit in the secondary endpoint of OS. Differences in patient population and the characteristics of the drugs could explain the differences in outcomes in the mentioned studies. Patient preference, toxicity profile, and prior use of CDK4/6i in the adjuvant setting should be considered when deciding between these agents.

Selected randomized phase III trials of CDK4/6 inhibitors in the first line setting.

Abbreviations: AI: aromatase inhibitor; BC: breast cancer; HER2: human epidermal growth factor receptor 2; HR: hazard ratio; HR+: hormone receptor positive; OS: overall survival; PFS: progression free survival.

Among postmenopausal patients, aromatase inhibitors (AI) have been traditionally used in the first line setting, while fulvestrant is used for those with pretreated disease. Questions regarding the optimal endocrine therapy partner to CDK4/6i remain. PARSIFAL was a phase 2 study (n = 486) where patients with untreated metastatic HR-positive disease were randomized to receive palbociclib with either letrozole or fulvestrant [ 5 ]. There were no significant differences between the arms. In 2023, the long-term outcomes of these patients of the PARSIFAL-LONG trial were presented (included 80% of the patients in PARSIFAL with a median follow-up of 59.7 months) [ 6 ]. No differences between the groups, were observed, and the combined cohorts had excellent long-term outcomes (with a median PFS of 33.2 months and median OS of 65.4 months). Patients with progression within 12 months of initiation of therapy had less favorable outcomes [ 6 ]. These findings support the use of AI for untreated patients and fulvestrant for those previously treated. Also support prior studies showing good long-term outcomes in patients treated with CDK4/6i, as discussed below.

Questions about the optimal timing of CDK4/6i have been studied. SONIA, a phase III trial, compared the use of CDK4/6i in the first vs. second-line settings [ 7 ]. Over 1000 patients were randomized (1:1) to AI in combination with CDK4/6i followed by fulvestrant at progression or AI followed by fulvestrant in combination with a CDK4/6i at the time of progression. Over 90% of patients received palbociclib. At a median follow-up of 37 months, the groups had no significant difference in PFS2 or OS. Limitations of this study include that most patients were treated with palbociclib and that the current standard of care after progression on CDK4/6i includes combination therapies with targeted agents, discussed below. The findings of the SONIA trial suggest postponing CDK4/6i for the second-line setting could be considered for selected patients. These data could impact low- and middle-income countries with limited resources. However, first-line therapy with ET and CDK4/6i remains the standard of care. Another important question associated with CDK4/6i is the use of these agents beyond progression while changing the ET backbone and continuing CDK4/6i. Three small phase II studies have shown conflicting results ( Table-2 ) and today, continuing CDK4/6i after progression is not considered standard of care [ [8] , [9] , [10] ].

Studies assessing the role of CDK4/6 inhibition after progression on CDK4/6 inhibition in metastatic breast cancer.

Abbreviations : AI: aromatase inhibitor; CDK: cyclin dependent kinase; ER: endocrine therapy; HER2: human epidermal growth factor receptor 2; HR: hazard ratio; HR + hormone receptor positive; PFS: progression free survival * The primary objective was to evaluate PSF between arms A and B.

Novel endocrine therapies have been developed over the past few years. Elacestrant is an oral selective estrogen receptor degrader (SERD) that was approved by the United States Food and Drug Administration (U.S. F.D.A.) in January of 2023 and by the European Medicines Agency (E.M.A) in September of 2023 based on the results of the EMERALD trial [ 11 ]. In this phase III study, standard ET (physician's choice) was compared with elacestrant. The latter showed an improvement in median PFS (3.8 vs. 1.9 months) for patients with tumors with ESR1 mutations (48% of the trial population). The benefit was more profound (mPFS of 8.61 months) among patients who had received at least 12 months of therapy with a CDK4/6i, irrespective of concomitant PIK3CA or P53 mutations [ 12 , 13 ]. Common adverse events included nausea, fatigue, vomiting, anorexia, and arthralgia. The approval of elacestrant added a new endocrine therapy to our therapeutic armamentarium in a selected group of patients and other novel therapies are under investigation.

Several drugs targeting the PIK3K/AKT/mTOR pathway have been approved, including everolimus [ 14 ], alpelisib [ 15 ], and more recently capivasertib [ 16 ] ( Table-3 ). In the phase III, CAPItello-291 study, capivasertib (AKT inhibitor) combined with fulvestrant improved PFS compared to fulvestrant alone. The benefit was more profound among patients with alterations in the AKT pathway (7.3 vs. 3.1 months, HR 0.5, 95%CI 0.38–0.65). The most common toxicities were rash (12%) and diarrhea (9.3%) and seem to compare favorably to the side effects of other inhibitors of this pathway, particularly as it relates to hyperglycemia ( Figure-1 ). The U.S. F.D.A. approved this agent in November of 2023 for patients with mBC who have received at least one prior ET and have tumors with PIK3CA , PTEN , or AKT1 alterations. Several other agents targeting this pathway are under investigation, an example is inavolisib, a potent PI3K-alpha inhibitor. In the phase 3 INAVO120 study, 325 patients with metastatic HR-positive BC who had disease recurrence on or within 12 months of adjuvant ET and whose tumors had PIK3CA mutations were randomized 1:1 to receive Palbociclib and fulvestrant ± inavolisib [ 17 ]. At a median follow-up of 21 months, the mPFS was 15 vs. 7.2 months (HR 0.43, 95%CI 0.32–0.59, p < 0.0001), favoring the triplet. There was also a numeric improvement in OS; however, longer follow-up is needed since the results are not mature. The ORR was 25 vs. 58%, favoring the triplet. In terms of safety, there was more stomatitis, anemia, hyperglycemia (even though only patients with normal fasting glucose and hemoglobin A1c were eligible), diarrhea, nausea, rash, stomatitis, and dry eye. This is a promising combination with patients with high-risk disease. However, this agent is currently not F.D.A. approved and is, at the time of this commentary, not commercially available.

Agents targeting the PIK3K/AKT/mTOR pathway in metastatic hormone receptor-positive breast cancer.

Abbreviations: CDK4/6: cyclin-dependent kinase 4/6 inhibitor; ITT: intention to treat; mPFS: median progression-free survival; WT: wildtype.

AKT pathway targeted agents approved for the treatment of breast cancer.

A.) Mechanism of action of everolimus, alpelisib, capivasertib.

B.) Selected side effects of interest of everolimus, alpelisib, capivasertib ( Created with BioRender.com , 2023 ).

Antibody-drug conjugates (ADCs) have reshaped the treatment paradigm of patients with metastatic BC. Currently, there are two ADCs approved by the F.D.A. and E.M.A for each BC subtype in the metastatic setting. The pivotal studies leading to the approval of these agents for the treatment of HR-positive BC, are summarized in Table-4 . For patients with HR-positive tumors, Sacituzumab Govitecan (SG) was approved by the U.S. F.D.A. and the E.M.A in 2023 for patients who have received at least two prior lines of chemotherapy in the metastatic setting [ 18 ]. Trastuzumab Deruxtecan (T-DXd) was approved in 2022 for patients with human epidermal growth factor receptor 2 (HER2) low-expressing metastatic BC who have received at least one prior line of chemotherapy in the metastatic setting [ 19 ]. The results of TROPION-Breast01 were recently presented, showing encouraging results for patients with advanced HR-positive BC. In the trial (n = 732) patients were randomized to receive Datopotamab Deruxtecan (Dato-DXd), a humanized anti-TROP2 antibody with a Topo-1 inhibitor payload, or investigator's choice chemotherapy. mPFS was 6.9 moths in the Dato-DXd arm vs 4.5 months (HR = 0.63; 95%CI 0.52–0.76; p < 0.0001) [ 20 ]. Dato-DXd was associated with increased dry eye and stomatitis and less neutropenia compared to investigator's choice chemotherapy, and while it is not approved by any regulatory agency, it is likely to become an option in the future.

Selected studies assessing the role of antibody-drug conjugates in the treatment of hormone receptor-positive metastatic breast cancer.

Abbreviations : DAR: drug to antibody ratio; DXd: deruxtecan; HER2: human epidermal growth factor receptor 2; HR: hazard ratio, HR+: hormone receptor positive; ILD: interstitial lung disease; ORR: overall response rate; OS: overall survival; PFS: progression free survival; U.S. FDA: United States Food and Drug Administration.

The optimal sequencing strategy for ADCs agents remains unknown, and cross-resistance is a concern as many of the approved agents share antibody targets and/or the mechanism of action of the cytotoxic payload. Several small and retrospective studies have shown that when ADCs are sequenced, the second ADC used is associated with modest response rates and a short duration of response [ [21] , [22] , [23] , [24] , [25] ]. However, how the PFS after a second ADC compares to standard chemotherapy remains unclear. These studies included heterogeneous and often heavily pretreated populations. Further research is needed to answer questions regarding mechanisms of resistance and ADC sequence, and studies are planned.

1.1. Triple negative breast cancer (TNBC)

Until recently, the treatment of patients with TNBC was limited to chemotherapy; however, in recent years, immunotherapy and ADCs have significantly impacted the treatment options for patients with advanced TNBC [ 19 , 26 , 27 ]. Several studies are assessing the safety and anti-tumor activity of combining immunotherapy and ADCs. In 2023, the results of the BEGONIA trial (arm 7) were presented at the annual ESMO meeting [ 28 ]. This phase 1b/2 study assessed the role of Dat-DXd and durvalumab as the first-line treatment for patients with metastatic TNBC. A total of 62 patients were enrolled, and the objective response rate was 79% (95%CI 66.8–88.3), irrespective of PD-L1 expression. The median PFS was 13.8 months, and the median duration of response was 15.5 months. The most common toxicities included nausea, stomatitis, alopecia, constipation, fatigue, and rash. The combination is currently being studied in a phase 3 trials and in a PD-L1 positive patient population.

1.2. ERBB2 overexpressing breast cancer

Several HER2-directed agents have been approved in recent years, significantly improving the outcomes of patients with ERBB2 overexpressing BC; however, those with brain metastases remain to receive limited benefit from our improved therapeutics. T-DXd is approved as a second-line agent for patients with metastatic ERBB2 overexpressing disease, and its role in patients with brain metastases remains unclear. A pooled analysis from the DESTINY-Breast 01, 02 and 03 trials assessed the outcomes of 148 patients with brain metastases (asymptomatic and 70% treated) treated with T-DXd and 83 in the comparator arms in the mentioned studies [ 29 ]. Patients with brain metastases treated with T-DXd had higher response rates and longer duration of response relative to the comparator arms, suggesting clinical activity of T-DXd in patients with ERBB2 overexpressing tumors and brain metastases, similar to what has been seen in small studies [ 30 ].

Trastuzumab emtansine (T-DM1) was the first ADC approved for the treatment of BC, it has now been studied in combination with other agents. The phase 3 HER2CLIMB-02 study assessed the combination of T-DM1 and the HER2-selective tyrosine kinase inhibitor tucatinib for the treatment of patients with metastatic ERBB2 overexpressing BC, including those with brain metastases (44%, from which had had active and had treated/stable brain metastases) [ 31 ]. A total of 460 patients were randomized to T-DM1 with or without tucatinib. At a median follow-up of 24 months, the mPFS was 9.5 vs. 7.4 months (HR = 0.76, 95%CI 0.61–0.95, p = 0.01), favoring the combination. Among patients with brain metastases the mPFS was 7.8 vs. 5.7 months (HR = 0.64, 95%CI 0.46–0.89), favoring the combination. OS data are not mature. There were more grade 3 toxicities (particularly diarrhea and liver function test abnormalities) and toxicities leading to treatment discontinuation in the combination arm (41 vs. 69% and 11 vs. 20%, respectively). Longer follow-up is needed to determine if this combination has a role in clinical practice and to help clinicians determine if a sequential approach of active agents is preferred to a combined approach or vice versa.

In addition to research evaluating new therapies, in 2023, there were also important studies helping us evaluate strategies aimed at decreasing toxicities and improve tolerance. Capecitabine is commonly used for the treatment of patients with all breast cancer subtypes. Two important studies using this agent were presented in ASCO 2023. The standard dose of capecitabine is 1250 mg/m2 twice daily, 14 days out of 21-day cycles. The X-7/7 trial compared the standard dose of the oral chemotherapy to a fixed dose (1500 mg twice daily), 7 days on, 7 days off [ 32 ]. A total of 153 patients were enrolled in the study. The 3, 6 and12 months-PFS was similar in both arms, however, patients in the experimental dose, had a significantly milder toxicity profile. D-TORCH was a study assessing the role of 1% topical diclofenac preventing capecitabine associated hand-foot-syndrome [ 33 , 34 ]. A total of 20 patients developed hand-foot syndrome, 6 (7.8%) in the diclofenac arm and 14 (19.7%) in the placebo arm (p = 0.034). X-7/7 and D-TORCH revealed relatively simple and low-cost interventions that can be considered to improve patients’ quality of life.

In conclusion, we reviewed some of the research presented in 2023, which was a very exciting year in the field of breast oncology, with cutting-edge research improving outcomes of patients living with advanced disease. The U.S. F.D.A. and the E.M.A. approved several agents to treat patients with metastatic BC and there is ongoing research to continue to improve patient outcomes of patients living with advanced BC while maintaining a good quality of life.

Declaration of competing interest

Mariana Chavez-MacGregor: Consultant/Advisory Board: Pfizer, Novartis, Astra Zeneca, Lilly, Genentech/Roche, Exact Sciences, Merck, Daiichi-Sankyo. Data Safety Monitoring Committee: Astra Zeneca, Genentech/Roche.

Ilana Schlam: Nothing to disclose.

Funding sources

Mariana Chavez-MacGregor is supported by Susan G. Komen (SAC220221) and the Breast Cancer Research Foundation (BCRF-22-190, BCRF-23-190).

CRediT authorship contribution statement

Ilana Schlam: Writing – original draft, Methodology, Investigation, Formal analysis, Data curation. Mariana Chavez-MacGregor: Writing – review & editing, Supervision, Resources, Project administration, Methodology, Investigation, Funding acquisition, Formal analysis, Data curation, Conceptualization.

• Open access
• Published: 24 April 2024

Breast cancer screening motivation and behaviours of women aged over 75 years: a scoping review

• Virginia Dickson-Swift 1 ,
• Joanne Adams 1 ,
• Evelien Spelten 1 ,
• Irene Blackberry 2 ,
• Carlene Wilson 3 , 4 , 5 &
• Eva Yuen 3 , 6 , 7 , 8  

BMC Women's Health volume  24 , Article number:  256 ( 2024 ) Cite this article

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This scoping review aimed to identify and present the evidence describing key motivations for breast cancer screening among women aged ≥ 75 years. Few of the internationally available guidelines recommend continued biennial screening for this age group. Some suggest ongoing screening is unnecessary or should be determined on individual health status and life expectancy. Recent research has shown that despite recommendations regarding screening, older women continue to hold positive attitudes to breast screening and participate when the opportunity is available.

All original research articles that address motivation, intention and/or participation in screening for breast cancer among women aged ≥ 75 years were considered for inclusion. These included articles reporting on women who use public and private breast cancer screening services and those who do not use screening services (i.e., non-screeners).

The Joanna Briggs Institute (JBI) methodology for scoping reviews was used to guide this review. A comprehensive search strategy was developed with the assistance of a specialist librarian to access selected databases including: the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline, Web of Science and PsychInfo. The review was restricted to original research studies published since 2009, available in English and focusing on high-income countries (as defined by the World Bank). Title and abstract screening, followed by an assessment of full-text studies against the inclusion criteria was completed by at least two reviewers. Data relating to key motivations, screening intention and behaviour were extracted, and a thematic analysis of study findings undertaken.

A total of fourteen (14) studies were included in the review. Thematic analysis resulted in identification of three themes from included studies highlighting that decisions about screening were influenced by: knowledge of the benefits and harms of screening and their relationship to age; underlying attitudes to the importance of cancer screening in women's lives; and use of decision aids to improve knowledge and guide decision-making.

The results of this review provide a comprehensive overview of current knowledge regarding the motivations and screening behaviour of older women about breast cancer screening which may inform policy development.

Peer Review reports

Introduction

Breast cancer is now the most commonly diagnosed cancer in the world overtaking lung cancer in 2021 [ 1 ]. Across the globe, breast cancer contributed to 25.8% of the total number of new cases of cancer diagnosed in 2020 [ 2 ] and accounts for a high disease burden for women [ 3 ]. Screening for breast cancer is an effective means of detecting early-stage cancer and has been shown to significantly improve survival rates [ 4 ]. A recent systematic review of international screening guidelines found that most countries recommend that women have biennial mammograms between the ages of 40–70 years [ 5 ] with some recommending that there should be no upper age limit [ 6 , 7 , 8 , 9 , 10 , 11 , 12 ] and others suggesting that benefits of continued screening for women over 75 are not clear [ 13 , 14 , 15 ].

Some guidelines suggest that the decision to end screening should be determined based on the individual health status of the woman, their life expectancy and current health issues [ 5 , 16 , 17 ]. This is because the benefits of mammography screening may be limited after 7 years due to existing comorbidities and limited life expectancy [ 18 , 19 , 20 , 21 ], with some jurisdictions recommending breast cancer screening for women ≥ 75 years only when life expectancy is estimated as at least 7–10 years [ 22 ]. Others have argued that decisions about continuing with screening mammography should depend on individual patient risk and health management preferences [ 23 ]. This decision is likely facilitated by a discussion between a health care provider and patient about the harms and benefits of screening outside the recommended ages [ 24 , 25 ]. While mammography may enable early detection of breast cancer, it is clear that false-positive results and overdiagnosis Footnote 1 may occur. Studies have estimated that up to 25% of breast cancer cases in the general population may be over diagnosed [ 26 , 27 , 28 ].

The risk of being diagnosed with breast cancer increases with age and approximately 80% of new cases of breast cancer in high-income countries are in women over the age of 50 [ 29 ]. The average age of first diagnosis of breast cancer in high income countries is comparable to that of Australian women which is now 61 years [ 2 , 4 , 29 ]. Studies show that women aged ≥ 75 years generally have positive attitudes to mammography screening and report high levels of perceived benefits including early detection of breast cancer and a desire to stay healthy as they age [ 21 , 30 , 31 , 32 ]. Some women aged over 74 participate, or plan to participate, in screening despite recommendations from health professionals and government guidelines advising against it [ 33 ]. Results of a recent review found that knowledge of the recommended guidelines and the potential harms of screening are limited and many older women believed that the benefits of continued screening outweighed the risks [ 30 ].

Very few studies have been undertaken to understand the motivations of women to screen or to establish screening participation rates among women aged ≥ 75 and older. This is surprising given that increasing age is recognised as a key risk factor for the development of breast cancer, and that screening is offered in many locations around the world every two years up until 74 years. The importance of this topic is high given the ambiguity around best practice for participation beyond 74 years. A preliminary search of Open Science Framework, PROSPERO, Cochrane Database of Systematic Reviews and JBI Evidence Synthesis in May 2022 did not locate any reviews on this topic.

This scoping review has allowed for the mapping of a broad range of research to explore the breadth and depth of the literature, summarize the evidence and identify knowledge gaps [ 34 , 35 ]. This information has supported the development of a comprehensive overview of current knowledge of motivations of women to screen and screening participation rates among women outside the targeted age of many international screening programs.

Materials and methods

Research question.

The research question for this scoping review was developed by applying the Population—Concept—Context (PCC) framework [ 36 ]. The current review addresses the research question “What research has been undertaken in high-income countries (context) exploring the key motivations to screen for breast cancer and screening participation (concepts) among women ≥ 75 years of age (population)?

Eligibility criteria

Participants.

Women aged ≥ 75 years were the key population. Specifically, motivations to screen and screening intention and behaviour and the variables that discriminate those who screen from those who do not (non-screeners) were utilised as the key predictors and outcomes respectively.

From a conceptual perspective it was considered that motivation led to behaviour, therefore articles that described motivation and corresponding behaviour were considered. These included articles reporting on women who use public (government funded) and private (fee for service) breast cancer screening services and those who do not use screening services (i.e., non-screeners).

The scope included high-income countries using the World Bank definition [ 37 ]. These countries have broadly similar health systems and opportunities for breast cancer screening in both public and private settings.

Types of sources

All studies reporting original research in peer-reviewed journals from January 2009 were eligible for inclusion, regardless of design. This date was selected due to an evaluation undertaken for BreastScreen Australia recommending expansion of the age group to include 70–74-year-old women [ 38 ]. This date was also indicative of international debate regarding breast cancer screening effectiveness at this time [ 39 , 40 ]. Reviews were also included, regardless of type—scoping, systematic, or narrative. Only sources published in English and available through the University’s extensive research holdings were eligible for inclusion. Ineligible materials were conference abstracts, letters to the editor, editorials, opinion pieces, commentaries, newspaper articles, dissertations and theses.

This scoping review was registered with the Open Science Framework database ( https://osf.io/fd3eh ) and followed Joanna Briggs Institute (JBI) methodology for scoping reviews [ 35 , 36 ]. Although ethics approval is not required for scoping reviews the broader study was approved by the University Ethics Committee (approval number HEC 21249).

Search strategy

A pilot search strategy was developed in consultation with an expert health librarian and tested in MEDLINE (OVID) and conducted on 3 June 2022. Articles from this pilot search were compared with seminal articles previously identified by the members of the team and used to refine the search terms. The search terms were then searched as both keywords and subject headings (e.g., MeSH) in the titles and abstracts and Boolean operators employed. A full MEDLINE search was then carried out by the librarian (see Table  1 ). This search strategy was adapted for use in each of the following databases: Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Web of Science and PsychInfo databases. The references of included studies have been hand-searched to identify any additional evidence sources.

Study/source of evidence selection

Following the search, all identified citations were collated and uploaded into EndNote v.X20 (Clarivate Analytics, PA, USA) and duplicates removed. The resulting articles were then imported into Covidence – Cochrane’s systematic review management software [ 41 ]. Duplicates were removed once importation was complete, and title and abstract screening was undertaken against the eligibility criteria. A sample of 25 articles were assessed by all reviewers to ensure reliability in the application of the inclusion and exclusion criteria. Team discussion was used to ensure consistent application. The Covidence software supports blind reviewing with two reviewers required at each screening phase. Potentially relevant sources were retrieved in full text and were assessed against the inclusion criteria by two independent reviewers. Conflicts were flagged within the software which allows the team to discuss those that have disagreements until a consensus was reached. Reasons for exclusion of studies at full text were recorded and reported in the scoping review. The Preferred Reporting Items of Systematic Reviews extension for scoping reviews (PRISMA-ScR) checklist was used to guide the reporting of the review [ 42 ] and all stages were documented using the PRISMA-ScR flow chart [ 42 ].

Data extraction

A data extraction form was created in Covidence and used to extract study characteristics and to confirm the study’s relevance. This included specific details such as article author/s, title, year of publication, country, aim, population, setting, data collection methods and key findings relevant to the review question. The draft extraction form was modified as needed during the data extraction process.

Data analysis and presentation

Extracted data were summarised in tabular format (see Table  2 ). Consistent with the guidelines for the effective reporting of scoping reviews [ 43 ] and the JBI framework [ 35 ] the final stage of the review included thematic analysis of the key findings of the included studies. Study findings were imported into QSR NVivo with coding of each line of text. Descriptive codes reflected key aspects of the included studies related to the motivations and behaviours of women > 75 years about breast cancer screening.

In line with the reporting requirements for scoping reviews the search results for this review are presented in Fig.  1 [ 44 ].

PRISMA Flowchart. From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. https://doi.org/10.1136/bmj.n71

A total of fourteen [ 14 ] studies were included in the review with studies from the following countries, US n  = 12 [ 33 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 ], UK n  = 1 [ 23 ] and France n  = 1 [ 56 ]. Sample sizes varied, with most containing fewer than 50 women ( n  = 8) [ 33 , 45 , 46 , 48 , 51 , 52 , 55 ]. Two had larger samples including a French study with 136 women (a sub-set of a larger sample) [ 56 ], and one mixed method study in the UK with a sample of 26 women undertaking interviews and 479 women completing surveys [ 23 ]. One study did not report exact numbers [ 50 ]. Three studies [ 47 , 53 , 54 ] were undertaken by a group of researchers based in the US utilising the same sample of women, however each of the papers focused on different primary outcomes. The samples in the included studies were recruited from a range of locations including primary medical care clinics, specialist medical clinics, University affiliated medical clinics, community-based health centres and community outreach clinics [ 47 , 53 , 54 ].

Data collection methods varied and included: quantitative ( n  = 8), qualitative ( n  = 5) and mixed methods ( n  = 1). A range of data collection tools and research designs were utilised; pre/post, pilot and cross-sectional surveys, interviews, and secondary analysis of existing data sets. Seven studies focused on the use of a Decision Aids (DAs), either in original or modified form, developed by Schonberg et al. [ 55 ] as a tool to increase knowledge about the harms and benefits of screening for older women [ 45 , 47 , 48 , 49 , 52 , 54 , 55 ]. Three studies focused on intention to screen [ 33 , 53 , 56 ], two on knowledge of, and attitudes to, screening [ 23 , 46 ], one on information needs relating to risks and benefits of screening discontinuation [ 51 ], and one on perceptions about discontinuation of screening and impact of social interactions on screening [ 50 ].

The three themes developed from the analysis of the included studies highlighted that decisions about screening were primarily influenced by: (1) knowledge of the benefits and harms of screening and their relationship to age; (2) underlying attitudes to the importance of cancer screening in women's lives; and (3) exposure to decision aids designed to facilitate informed decision-making. Each of these themes will be presented below drawing on the key findings of the appropriate studies. The full dataset of extracted data can be found in Table  2 .

Knowledge of the benefits and harms of screening ≥ 75 years

The decision to participate in routine mammography is influenced by individual differences in cognition and affect, interpersonal relationships, provider characteristics, and healthcare system variables. Women typically perceive mammograms as a positive, beneficial and routine component of care [ 46 ] and an important aspect of taking care of themselves [ 23 , 46 , 49 ]. One qualitative study undertaken in the US showed that few women had discussed mammography cessation or the potential harms of screening with their health care providers and some women reported they would insist on receiving mammography even without a provider recommendation to continue screening [ 46 ].

Studies suggested that ageing itself, and even poor health, were not seen as reasonable reasons for screening cessation. For many women, guidance from a health care provider was deemed the most important influence on decision-making [ 46 ]. Preferences for communication about risk and benefits were varied with one study reporting women would like to learn more about harms and risks and recommended that this information be communicated via physicians or other healthcare providers, included in brochures/pamphlets, and presented outside of clinical settings (e.g., in community-based seniors groups) [ 51 ]. Others reported that women were sometimes sceptical of expert and government recommendations [ 33 ] although some were happy to participate in discussions with health educators or care providers about breast cancer screening harms and benefits and potential cessation [ 52 ].

Underlying attitudes to the importance of cancer screening at and beyond 75 years

Included studies varied in describing the importance of screening, with some attitudes based on past attendance and some based on future intentions to screen. Three studies reported findings indicating that some women intended to continue screening after 75 years of age [ 23 , 45 , 46 ], with one study in the UK reporting that women supported an extension of the automatic recall indefinitely, regardless of age or health status. In this study, failure to invite older women to screen was interpreted as age discrimination [ 23 ]. The desire to continue screening beyond 75 was also highlighted in a study from France that found that 60% of the women ( n  = 136 aged ≥ 75) intended to pursue screening in the future, and 27 women aged ≥ 75, who had never undergone mammography previously (36%), intended to do so in the future [ 56 ]. In this same study, intentions to screen varied significantly [ 56 ]. There were no sociodemographic differences observed between screened and unscreened women with regard to level of education, income, health risk behaviour (smoking, alcohol consumption), knowledge about the importance and the process of screening, or psychological features (fear of the test, fear of the results, fear of the disease, trust in screening impact) [ 56 ]. Further analysis showed that three items were statistically correlated with a higher rate of attendance at screening: (1) screening was initiated by a physician; (2) the women had a consultation with a gynaecologist during the past 12 months; and (3) the women had already undergone at least five screening mammograms. Analysis highlighted that although average income, level of education, psychological features or other types of health risk behaviours did not impact screening intention, having a mammogram previously impacted likelihood of ongoing screening. There was no information provided that explained why women who had not previously undergone screening might do so in the future.

A mixed methods study in the UK reported similar findings [ 23 ]. Utilising interviews ( n  = 26) and questionnaires ( n  = 479) with women ≥ 70 years (median age 75 years) the overwhelming result (90.1%) was that breast screening should be offered to all women indefinitely regardless of age, health status or fitness [ 23 ], and that many older women were keen to continue screening. Both the interview and survey data confirmed women were uncertain about eligibility for breast screening. The survey data showed that just over half the women (52.9%) were unaware that they could request mammography or knew how to access it. Key reasons for screening discontinuation were not being invited for screening (52.1%) and not knowing about self-referral (35.1%).

Women reported that not being invited to continue screening sent messages that screening was no longer important or required for this age group [ 23 ]. Almost two thirds of the women completing the survey (61.6%) said they would forget to attend screening without an invitation. Other reasons for screening discontinuation included transport difficulties (25%) and not wishing to burden family members (24.7%). By contrast, other studies have reported that women do not endorse discontinuation of screening mammography due to advancing age or poor health, but some may be receptive to reducing screening frequency on recommendation from their health care provider [ 46 , 51 ].

Use of Decision Aids (DAs) to improve knowledge and guide screening decision-making

Many women reported poor knowledge about the harms and benefits of screening with studies identifying an important role for DAs. These aids have been shown to be effective in improving knowledge of the harms and benefits of screening [ 45 , 54 , 55 ] including for women with low educational attainment; as compared to women with high educational attainment [ 47 ]. DAs can increase knowledge about screening [ 47 , 49 ] and may decrease the intention to continue screening after the recommended age [ 45 , 52 , 54 ]. They can be used by primary care providers to support a conversation about breast screening intention and reasons for discontinuing screening. In one pilot study undertaken in the US using a DA, 5 of the 8 women (62.5%) indicated they intended to continue to receive mammography; however, 3 participants planned to get them less often [ 45 ]. When asked whether they thought their physician would want them to get a mammogram, 80% said “yes” on pre-test; this figure decreased to 62.5% after exposure to the DA. This pilot study suggests that the use of a decision-aid may result in fewer women ≥ 75 years old continuing to screen for breast cancer [ 45 ].

Similar findings were evident in two studies drawing on the same data undertaken in the US [ 48 , 53 ]. Using a larger sample ( n  = 283), women’s intentions to screen prior to a visit with their primary care provider and then again after exposure to the DA were compared. Results showed that 21.7% of women reduced their intention to be screened, 7.9% increased their intentions to be screened, and 70.4% did not change. Compared to those who had no change or increased their screening intentions, women who had a decrease in screening intention were significantly less likely to receive screening after 18 months. Generally, studies have shown that women aged 75 and older find DAs acceptable and helpful [ 47 , 48 , 49 , 55 ] and using them had the potential to impact on a women’s intention to screen [ 55 ].

Cadet and colleagues [ 49 ] explored the impact of educational attainment on the use of DAs. Results highlight that education moderates the utility of these aids; women with lower educational attainment were less likely to understand all the DA’s content (46.3% vs 67.5%; P < 0.001); had less knowledge of the benefits and harms of mammography (adjusted mean ± standard error knowledge score, 7.1 ± 0.3 vs 8.1 ± 0.3; p < 0.001); and were less likely to have their screening intentions impacted (adjusted percentage, 11.4% vs 19.4%; p  = 0.01).

This scoping review summarises current knowledge regarding motivations and screening behaviours of women over 75 years. The findings suggest that awareness of the importance of breast cancer screening among women aged ≥ 75 years is high [ 23 , 46 , 49 ] and that many women wish to continue screening regardless of perceived health status or age. This highlights the importance of focusing on motivation and screening behaviours and the multiple factors that influence ongoing participation in breast screening programs.

The generally high regard attributed to screening among women aged ≥ 75 years presents a complex challenge for health professionals who are focused on potential harm (from available national and international guidelines) in ongoing screening for women beyond age 75 [ 18 , 20 , 57 ]. Included studies highlight that many women relied on the advice of health care providers regarding the benefits and harms when making the decision to continue breast screening [ 46 , 51 , 52 ], however there were some that did not [ 33 ]. Having a previous pattern of screening was noted as being more significant to ongoing intention than any other identified socio-demographic feature [ 56 ]. This is perhaps because women will not readily forgo health care practices that they have always considered important and that retain ongoing importance for the broader population.

For those women who had discontinued screening after the age of 74 it was apparent that the rationale for doing so was not often based on choice or receipt of information, but rather on factors that impact decision-making in relation to screening. These included no longer receiving an invitation to attend, transport difficulties and not wanting to be a burden on relatives or friends [ 23 , 46 , 51 ]. Ongoing receipt of invitations to screen was an important aspect of maintaining a capacity to choose [ 23 ]. This was particularly important for those women who had been regular screeners.

Women over 75 require more information to make decisions regarding screening [ 23 , 52 , 54 , 55 ], however health care providers must also be aware that the element of choice is important for older women. Having a capacity to choose avoids any notion of discrimination based on age, health status, gender or sociodemographic difference and acknowledges the importance of women retaining control over their health [ 23 ]. It was apparent that some women would choose to continue screening at a reduced frequency if this option was available and that women should have access to information facilitating self-referral [ 23 , 45 , 46 , 51 , 56 ].

Decision-making regarding ongoing breast cancer screening has been facilitated via the use of Decision Aids (DAs) within clinical settings [ 54 , 55 ]. While some studies suggest that women will make a decision regardless of health status, the use of DAs has impacted women’s decision to screen. While this may have limited benefit for those of lower educational attainment [ 48 ] they have been effective in improving knowledge relating to harms and benefits of screening particularly where they have been used to support a conversation with women about the value of screening [ 54 , 55 , 56 ].

Women have identified challenges in engaging in conversations with health care providers regarding ongoing screening, because providers frequently draw on projections of life expectancy and over-diagnosis [ 17 , 51 ]. As a result, these conversations about screening after age 75 years often do not occur [ 46 ]. It is likely that health providers may need more support and guidance in leading these conversations. This may be through the use of DAs or standardised checklists. It may be possible to incorporate these within existing health preventive measures for this age group. The potential for advice regarding ongoing breast cancer screening to be available outside of clinical settings may provide important pathways for conversations with women regarding health choices. Provision of information and advice in settings such as community based seniors groups [ 51 ] offers a potential platform to broaden conversations and align sources of information, not only with health professionals but amongst women themselves. This may help to address any misconception regarding eligibility and access to services [ 23 ]. It may also be aligned with other health promotion and lifestyle messages provided to this age group.

Limitations of the review

The searches that formed the basis of this review were carried in June 2022. Although the search was comprehensive, we have only captured those studies that were published in the included databases from 2009. There may have been other studies published outside of these periods. We also limited the search to studies published in English with full-text availability.

The emphasis of a scoping review is on comprehensive coverage and synthesis of the key findings, rather than on a particular standard of evidence and, consequently a quality assessment of the included studies was not undertaken. This has resulted in the inclusion of a wide range of study designs and data collection methods. It is important to note that three studies included in the review drew on the same sample of women (283 over > 75)[ 49 , 53 , 54 ]. The results of this review provide valuable insights into motivations and behaviours for breast cancer screening for older women, however they should be interpreted with caution given the specific methodological and geographical limitations.

Conclusion and recommendations

This scoping review highlighted a range of key motivations and behaviours in relation to breast cancer screening for women ≥ 75 years of age. The results provide some insight into how decisions about screening continuation after 74 are made and how informed decision-making can be supported. Specifically, this review supports the following suggestions for further research and policy direction:

Further research regarding breast cancer screening motivations and behaviours for women over 75 would provide valuable insight for health providers delivering services to women in this age group.

Health providers may benefit from the broader use of decision aids or structured checklists to guide conversations with women over 75 regarding ongoing health promotion/preventive measures.

Providing health-based information in non-clinical settings frequented by women in this age group may provide a broader reach of information and facilitate choices. This may help to reduce any perception of discrimination based on age, health status or socio-demographic factors.

Availability of data and materials

All data generated or analysed during this study is included in this published article (see Table  2 above).

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Acknowledgements

We would like to acknowledge Ange Hayden-Johns (expert librarian) who assisted with the development of the search criteria and undertook the relevant searches and Tejashree Kangutkar who assisted with some of the Covidence work.

This work was supported by funding from the Australian Government Department of Health and Aged Care (ID: Health/20–21/E21-10463).

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VDS conceived and designed the scoping review. VDS & JA developed the search strategy with librarian support, and all authors (VDS, JA, ES, IB, CW, EY) participated in the screening and data extraction stages and assisted with writing the review. All authors provided editorial support and read and approved the final manuscript prior to submission.

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Dickson-Swift, V., Adams, J., Spelten, E. et al. Breast cancer screening motivation and behaviours of women aged over 75 years: a scoping review. BMC Women's Health 24 , 256 (2024). https://doi.org/10.1186/s12905-024-03094-z

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DOI : https://doi.org/10.1186/s12905-024-03094-z

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A mathematical model for the treatment of breast cancer

A mathematical model for the treatment of breast cancer using magnetic nanoparticles was developed in a study conducted by Dr Victor Job and Dr Nagarani Ponakala of the Department of Mathematics at The University of the West Indies (UWI), Mona campus, and collaborators from the UWI St Augustine Campus and I.I.T. Kharagpur (India).

This form of treatment, called magnetic hyperthermia, is performed by injecting magnetic nanoparticles into cancerous tissues and using a magnetic field to generate heat in order to destroy the cancerous cells. The model constructed in this study simulates the nanoparticle injection process and subsequent heating of tissues by the magnetic field in the cases of FePt nanoparticles and FeCrNbB nanoparticles.

Computer implementation of the mathematical solution was performed using the software FreeFEM++. The primary objective of the study was to determine the factors influencing thermal cell damage in cancerous tissue, while limiting damage to the surrounding regions of healthy breast gland tissue, fat and the overlying skin tissue.

The results revealed that the effectiveness of hyperthermia treatment is dependent on parameters such as injection duration, injected nanoparticle volume fraction, and magnetic field strength and frequency. These findings can be used to improve the clinical efficacy of magnetic hyperthermia therapy for glandular breast cancers and other types of adenocarcinomas that may be treated via direct injection of magnetic nanoparticles into cancerous tissues.

DEEPER QUANTITATIVE INSIGHT

The research conducted in this study has been published in Volume 192, Part A (108405) of the International Journal of Thermal Sciences (Elsevier, Impact Factor 4.5).The research was conducted over a two-year period from July 2021 to August 2023.

According to Dr Job, the mathematical model developed for the magnetic hyperthermia (elevated temperature) treatment of breast cancer is comprised of equations that describe the process of injecting magnetic nanoparticles into a breast tumour, and the spread and deposition of these nanoparticles into surrounding healthy tissues of the breast gland, fat and skin.

“In this research, two types of nanoparticles were considered; namely, iron-platinum alloy and an iron-chromium-based alloy. The model also predicts the blood flow, heat generated and thermal cell death within these tissues when an alternating magnetic field is applied as part of the therapeutic process,” Dr Job said.

Mathematical models are actively being developed to offer deeper quantitative insight on the success of hyperthermia therapies conducted in clinical trials, in vivo mouse studies and in vitro studies for cancers of the breast, liver, prostate, brain and skin.

“The vast majority of these models focus on the commonly used magnetite nanoparticles, but in our breast cancer model we conduct a novel comparison of two promising iron-alloy nanoparticles and their therapeutic effects on thermal damage to cancerous and surrounding healthy tissues during magnetic hyperthermia,” Dr Ponakala said.

MINIMAL UNWANTED SIDE EFFECTS

The most common forms of cancer treatment currently available are chemotherapy and radiation therapy. However, patients undergoing chemotherapy often suffer from major systemic side effects such as vomiting, hair loss and extreme fatigue.

Although radiation therapy avoids some of these systemic side effects and is a localised form of cancer therapy, radiation therapy patients experience significant unwanted local side effects like tenderness, skin thinning and scarring.

“Magnetic hyperthermia therapy offers an alternative localised cancer treatment with minimal unwanted side effects (systemic or local). Our mathematical model was developed in order to better understand the factors that influence the effectiveness of hyperthermia therapy for breast cancer via injection of nanoparticles, while limiting unwanted thermal damage to the surrounding healthy tissues,” Dr Ponakala said.

The primary goal of this research is to improve the clinical effectiveness of therapies for breast tumours and other forms of cancer that can be treated through direct injection of magnetic nanoparticles.

“The breast cancer model effectively simulates both the nanoparticle injection and heat generation processes that comprise magnetic hyperthermia therapy. The results obtained from the model accurately predict the effects of hyperthermia on cancer cell tissue damage over the duration of therapy, and confirms that a significant side effect of this therapy is cell damage to skin tissues,” Dr Job added.

The findings also determine that damage to healthy tissues can be reduced by using iron-platinum nanoparticles and controlling factors such as the duration of nanoparticle injection, concentration of injected nanoparticles, and the frequency and amplitude of the magnetic field

Faculty of Science and Technology on Instagram @uwimona_fst and on Facebook at The Faculty of Science and Technology, The UWI Mona. For inquiries, WhatsApp us at 1-876-552-4691, call us at 1-876-927-1660-9, or email us at [email protected] .

Published on 24 Apr, 2024

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• Introduction
• Article Information

Participants included in the DELCaP Study, a prospective, observational questionnaire study ancillary to the Southwest Oncology Group (SWOG) S0221 trial, a randomized treatment trial for high-risk breast cancer. Questionnaire 1 (Q1) was completed at the time of S0221 registration, before the initiation of chemotherapy, and represents lifestyles in the 4 weeks before diagnosis. Questionnaire 2 (Q2) was completed at the completion of active treatment (approximately 6 months after trial registration) and represents lifestyles during treatment. Questionnaire 3 (Q3) was completed 1 year after trial registration and represents lifestyles during the previous year. Questionnaire 4 (Q4) was completed 2 years after trial registration and represents lifestyles in the previous year. Patients who did not return subsequent questionnaires but did not formally withdraw from the study were identified as passive refusals; patients withdrawing from study were identified as active refusals.

Kaplan-Meier plots representing associations of lifestyle index score tertiles at baseline with disease-free survival (A) and overall survival (B) in the DELCaP Study. The highest tertile reflects the strongest adherence to the American Institute for Cancer Research and American Cancer Society cancer prevention recommendations.

Forest plots depicting the hazard ratios (HRs) and 95% CIs representing the time-varying associations of the aggregate lifestyle index and individual lifestyle scores with disease recurrence (A) and mortality (B) in the DELCaP Study. For each lifestyle domain and the lifestyle index, the lowest level of adherence (ie, the least healthy behavior) served as the referent group. All multivariable models were adjusted for age at study enrollment, number of positive nodes, tumor subtype, and a stratification factor for treatment arm in Southwest Oncology Group S0221 trial. A, For disease recurrence, significant dose-dependent associations were observed for physical activity ( P  < .001 for trend), fruit and vegetable intake ( P  = .04 for trend), sugar-sweetened beverage (SSB) consumption ( P  = .03 for trend), and smoking status ( P  = .01 for trend). B, For mortality, significant dose-dependent associations were observed for physical activity ( P  < .001 for trend), body mass index (BMI) ( P  = .05 for trend), food and vegetable consumption ( P  = .03 for trend), red and processed meats ( P  = .003 for trend), SSB consumption ( P  = .002 for trend), and smoking ( P  = .002 for trend).

Leave-out analyses depict the percent change in hazard ratios (HRs) representing the association of the aggregate lifestyle index score with hazards of disease recurrence (A) and hazards of mortality (B) in the Diet, Exercise, Lifestyles, and Cancer Prognosis (DELCaP) Study at 4 time points (Q1-Q4). Questionnaire 1 (Q1) represents lifestyles before diagnosis, Q2 represents lifestyles during treatment, Q3 represents lifestyles 1 year after enrollment (6 months after treatment completion), and Q4 represents lifestyles 2 years after enrollment. Bars to the right of the vertical lines represents a positive percent change in effect, indicating that the HR representing the association of the lifestyle index with survival was attenuated when that factor was excluded (ie, the HR increased). A negative percent change indicates the HR decreased (ie, the association was strengthened) when the factor was excluded. Thus, the factor with the largest positive percent increase was the most important contributor to the association of the lifestyle index with the outcome at the respective time point. BMI indicates body mass index; SSB, sugar-sweetened beverage.

eMethods. Supplemental Methods

eTable. Epidemiological and Clinical Characteristics of the DELCaP Study Population According to the Aggregate Lifestyle Index Score

eFigure 1. Directed Acyclic Graphs

eFigure 2. Hazard Ratios (HR) and 95% Confidence Intervals (CI) Representing Associations of the Lifestyle Index Score (LIS) and Individual Lifestyles Before Diagnosis (Q1) With (A) Disease Recurrence and (B) Mortality in the DELCaP Study

eFigure 3. Hazard Ratios (HR) and 95% Confidence Intervals (CI) Representing Associations of the Lifestyle Index Score (LIS) and Adherence to Individual Lifestyle Recommendations During Treatment (Q2) With (A) Disease Recurrence and (B) All-Cause Mortality in the DELCaP Study

eFigure 4. Hazard Ratios (HR) and 95% Confidence Intervals (CI) Representing Associations of the Lifestyle Index Score and Adherence to Individual Lifestyle Recommendations at One-Year Follow-Up (Q3) With (A) Disease Recurrence and (B) All-Cause Mortality in the DELCaP Study

eFigure 5. Hazard Ratios (HR) and 95% Confidence Intervals (CI) Representing Associations of the Lifestyle Index Score and Adherence to Individual Lifestyle Recommendations at Two-Year Follow-up (Q4) With (A) Disease Recurrence and (B) All-Cause Mortality in the DELCaP Study

eFigure 6. Hazard Ratios (HR) and 95% Confidence Intervals (CI) Representing Associations of the Aggregate Lifestyle Index Score With (A) Disease Recurrence and (B) All-Cause Mortality According to Tumor Subtype in the DELCaP Study

eReferences

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Cannioto RA , Attwood KM , Davis EW, et al. Adherence to Cancer Prevention Lifestyle Recommendations Before, During, and 2 Years After Treatment for High-risk Breast Cancer. JAMA Netw Open. 2023;6(5):e2311673. doi:10.1001/jamanetworkopen.2023.11673

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Adherence to Cancer Prevention Lifestyle Recommendations Before, During, and 2 Years After Treatment for High-risk Breast Cancer

• 1 Department of Cancer Prevention & Control, Roswell Park Comprehensive Cancer Center, Buffalo, New York
• 2 Department of Biostatistics and Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, New York
• 3 Slone Epidemiology Center, Boston University, Boston, Massachusetts
• 4 Southwest Oncology Group Statistics and Data Management Center, Fred Hutchinson Cancer Center, University of Washington, Seattle
• 5 Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York
• 6 Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, Ohio
• 7 Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC
• 8 Department of Oncology, Mayo Clinic College of Medicine, Rochester, Minnesota
• 9 Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston
• 10 Fred Hutchinson Cancer Center and the Seattle Cancer Care Alliance, University of Washington, Seattle-
• 11 Division of Hematology/Oncology, Cardinal Bernardin Cancer Center, Loyola University Chicago Stritch School of Medicine, Chicago, Illinois

Question   Is adherence to cancer prevention lifestyle recommendations before, during, and after chemotherapy associated with disease recurrence and mortality in patients with high-risk breast cancer?

Findings   In this prospective cohort study of 1340 patients with high-risk breast cancer, strongest adherence to the American Cancer Society and American Institute of Cancer Research prevention recommendations was associated with a 37% reduced hazard of breast cancer recurrence and a 58% reduced hazard of mortality.

Meaning   These findings suggest that education and implementation strategies to help patients adhere to cancer prevention recommendations throughout the cancer care continuum may be warranted in breast cancer.

Importance   The American Institute for Cancer Research and American Cancer Society regularly publish modifiable lifestyle recommendations for cancer prevention. Whether these recommendations have an impact on high-risk breast cancer survival remains unknown.

Objective   To investigate whether adherence to cancer prevention recommendations before, during, and 1 and 2 years after breast cancer treatment was associated with disease recurrence or mortality.

Design, Setting, and Participants   The Diet, Exercise, Lifestyles, and Cancer Prognosis Study (DELCaP) was a prospective, observational cohort study designed to assess lifestyles before diagnosis, during treatment, and at 1 and 2 years after treatment completion, implemented ancillary to the Southwest Oncology Group (SWOG) S0221 trial, a multicenter trial that compared chemotherapy regimens in breast cancer. Participants were chemotherapy-naive patients with pathologic stage I to III high-risk breast cancer, defined as node-positive disease with hormone receptor–negative tumors larger than 1 cm or any tumor larger than 2 cm. Patients with poor performance status and comorbidities were excluded from S0221. The study was conducted from January 1, 2005, to December 31, 2010; mean (SD) follow-up time for those not experiencing an event was 7.7 (2.1) years through December 31, 2018. The analyses reported herein were performed from March 2022 to January 2023.

Exposure   An aggregated lifestyle index score comprising data from 4 time points and 7 lifestyles, including (1) physical activity, (2) body mass index, (3) fruit and vegetable consumption, (4) red and processed meat intake, (5) sugar-sweetened beverage consumption, (6) alcohol consumption, and (7) smoking. Higher scores indicated healthier lifestyle.

Main Outcomes and Measures   Disease recurrence and all-cause mortality.

Results   A total of 1340 women (mean [SD] age, 51.3 [9.9] years) completed the baseline questionnaire. Most patients were diagnosed with hormone-receptor positive breast cancer (873 [65.3%]) and completed some education beyond high school (954 [71.2%]). In time-dependent multivariable analyses, patients with highest vs lowest lifestyle index scores experienced a 37.0% reduction in disease recurrence (hazard ratio, 0.63; 95% CI, 0.48-0.82) and a 58.0% reduction in mortality (hazard ratio, 0.42; 95% CI, 0.30-0.59).

Conclusions and Relevance   In this observational study of patients with high-risk breast cancer, strongest collective adherence to cancer prevention lifestyle recommendations was associated with significant reductions in disease recurrence and mortality. Education and implementation strategies to help patients adhere to cancer prevention recommendations throughout the cancer care continuum may be warranted in breast cancer.

The American Institute for Cancer Research (AICR) and the American Cancer Society (ACS) regularly publish cancer prevention recommendations for decreasing the risk of developing cancer. 1 , 2 The most recent recommendations include (1) maintaining a healthy body weight; (2) meeting the physical activity (PA) guidelines; (3) eating a colorful variety of vegetables, fruits, and plenty of whole grains; (4) limiting red and processed meats, fast food, and other highly processed food; (5) avoiding or limiting sugar-sweetened beverages; (6) avoiding or limiting alcohol consumption to 1 drink or fewer per day; and (8) avoiding cigarette smoking. 1 - 4 Despite recommendations to adhere to prevention guidelines after a cancer diagnosis, which lifestyle factors have an impact on cancer outcomes, and whether those factors work together, remains unknown.

Recently, a National Cancer Institute collaborative group published guidance for developing analytic approaches to address this gap in knowledge. 3 , 4 The resultant work encourages researchers to implement a standardized lifestyle score to investigate how adherence to prevention recommendations may impact outcomes, including cancer mortality. 3 , 4

To date, epidemiologic evidence supports an association for some, but not all, individual lifestyle recommendations with breast cancer (BC) survival. 5 - 17 However, because many lifestyle behaviors co-occur, investigations of independent behaviors may ignore cumulative effects that could impact recurrence or mortality. 18 Thus, an aggregate lifestyle score may better reflect whether adhering to cancer prevention recommendations is also associated with BC outcomes. 19 In accordance with National Cancer Institute guidance, 3 , 4 we created a lifestyle index score (LIS) to investigate whether adherence to overlapping AICR and ACS recommendations before, during, and after treatment was associated with recurrence or mortality among patients with high-risk BC enrolled in the Diet, Exercise, Lifestyles, and Cancer Prognosis (DELCaP) Study.

The DELCaP Study was a prospective, observational cohort study ancillary to a multicenter phase 3 clinical trial led by the Southwest Oncology Group (SWOG) (S0221; NCT00070564 ) 20 that randomly assigned patients with high-risk stage I to III BC to different treatment schedules with doxorubicin, cyclophosphamide, and paclitaxel. DELCaP was initiated to assess the role of lifestyle factors before, during, and after treatment in relation to BC outcomes. 21 - 23 Details regarding enrollment, inclusion, and exclusion criteria for S0221 have been previously described. 21 Briefly, patients were excluded if they received prior systemic therapy or had comorbidities, abnormal organ function, or poor performance status. Patients experiencing toxicities or treatment delays greater than 3 weeks were removed from the trial. Approval to initiate DELCaP was obtained from the institutional review boards at Roswell Park and at all participating institutions that enrolled patients in S0221. The study was conducted from January 1, 2005, to December 31, 2010; mean (SD) follow-up time among patients not experiencing an event was 7.7 (2.1) years through December 31, 2018. A total of 2014 patients from S0221 were eligible to participate in DELCaP; 1607 (70.8%) provided written informed consent, and 1340 (83.4%) completed the baseline questionnaire. Response rates for each subsequent questionnaire and reasons for loss to follow-up are shown in Figure 1 . This report follows the Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) reporting guideline for cohort studies. 24

A detailed description of the DELCaP questionnaire has been previously published. 21 The questionnaire was adapted from the VITAL Study, which was extensively validated. 23 The baseline questionnaire (Q1) was administered at enrollment and queried lifestyles 1 month before diagnosis. Questionnaire 2 (Q2) was administered at the time of treatment completion to patients completing Q1 and assessed lifesyles during treatment. Questionnaire 3 (Q3) was administered to patients completing Q1 and Q2 approximately 1 year after study enrollment and assessed lifestyles in the preceding year. Questionnaire 4 (Q4) was administered 2 years after study enrollment to patients completing Q1 to Q3 and queried lifestyles in the preceding year. Self-identified race and ethnicity were queried using the DELCaP questionnaire. For both questionnaire items assessing race and ethnicity, respondents were instructed to mark all that apply, which included options for “other” and “don’t know.” Throughout the study, participants submitting surveys with missing responses were contacted by Clinical Research Associates to maximize completeness.

We created a LIS 3 , 4 that reflected lifestyle adherence at 4 time points to the following 7 cancer prevention recommendations: (1) aim to meet the PA guidelines, (2) maintain a normal body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), (3) increase consumption of a colorful variety of fruit and vegetables, (4) limit consumption of red and processed meat, (5) limit sugar-sweetened beverage consumption, (6) avoid alcohol, and (7) avoid smoking. For each lifestyle, a score of 1 point represented strongest adherence, a half point represented partial adherence, and a zero represented nonadherence. 3 , 4 To create the LIS at each time point, adherence scores for each lifestyle were summed, with total scores ranging from 0 (nonadherence) to 7 (strongest adherence). 3 , 4 To account for lifestyle changes over time, an aggregated time-varying LIS was calculated, comprising data from Q1 through Q4, and served as the primary exposure of interest. For all multivariable analyses, lifestyle adherence scores were categorized into tertiles, with the highest tertile reflecting strongest adherence. Detailed methods for assessing individual lifestyles and calculating and parameterizing adherence scores are provided in the eMethods in Supplement 1 .

The primary analytic outcomes of interest were hazards of disease recurrence and all-cause mortality. For recurrence, survival time included time from randomization to first instance of disease recurrence, new breast primary tumor, or death from any cause, whichever came first. Recurrence was assessed via physical examination every 6 months for 5 years and annually for up to 15 years or until death. For mortality, survival time included time from randomization to death from any cause. Vital status was ascertained from medical records, patient and family contact, obituaries, and national indexes. Patients without disease recurrence and those who were still alive at the time of analysis were censored on the date of their last clinical contact.

The analyses reported herein were performed from January 2022 to March 2023. First, we examined univariable associations of patient characteristics with BC outcomes and the aggregate LIS. Second, Kaplan-Meier curves were generated to characterize the disease-free and overall survival experience according to the baseline LIS. Third, in primary multivariable analyses, time-dependent Cox proportional hazards regression models were used to assess associations of the aggregated LIS with BC outcomes. Considering the LIS as a time-varying exposure appropriately accounted for changes in lifestyles throughout the study while also accounting for the possibility of immortal time bias. 25 , 26 Fourth, in secondary multivariable analyses, we used standard Cox proportional hazards regression models to assess associations of the LIS with BC outcomes at each time point. For Q2 to Q4, we conducted landmark analyses to further account for immortal time bias. However, because the landmark time became shorter with each successive questionnaire and data points were lost, these analyses provide an incomplete representation of the exposure-outcome association. 26 Fifth, to assess the contribution of each individual lifestyle in the aggregated LIS-outcome association at each time point, we conducted time-dependent leave-out analyses. To accomplish this, we excluded each lifestyle factor from the aggregated LIS at each time point and quantified the magnitude and direction of change in the observed association with BC outcomes using the remaining 6 factors. 18

For all multivariable analyses, we a priori defined age at baseline and a stratification factor corresponding to treatment assignment from S0221 as important covariates. Next, we applied well-established conceptual and empirical methods for identifying additional confounders as described in the eMethods in Supplement 1 . Briefly, we used the definition of confounding, 27 directed acyclic graphs (eFigure 1 in Supplement 1 ), the change-in-estimate method, 28 and stepwise regression 29 to identify confounders for adjustment in multivariable models.

Despite meeting conceptual criteria of confounding, adjustment for self-identified race, self-identified ethnicity, educational attainment, and menopause status did not change estimates of association, and these factors were not statistically significant factors in stepwise regression. Conversely, the number of positive nodes, ERBB2 (previously HER2/neu ) (OMIM 164870 ) status, and ER (OMIM 620207 ) /PGR (OMIM 607311 ) status were statistically significant factors. Thus, fully adjusted multivariable models included age at study enrollment, number of positive nodes, ERBB2 and ER/PGR status, and a stratification factor for treatment arm.

To detect departures from model assumptions that may have influenced our estimates, we used standard diagnostic methods, including examining residuals, ad hoc time-varying covariates of a discretized time scale, and Kaplan-Meier curves. For patients with 1 or more missing surveys, data were classified as missing from nonresponse and were assumed to be missing not at random. As previously described, 21 Taylor series variance estimation was used to account for missing data; observations with missing values were included in computing the degrees of freedom. 30

We conducted a series of sensitivity analyses to assess the potential role of selection bias or confounding in our estimates. First, to assess potential selection effects into DELCaP, we compared 5-year survival of all patients enrolled in S0221 with patients enrolled in DELCaP. Second, to examine the possibility that lifestyles were associated with questionnaire response rates, we examined the association of LIS with nonresponse at each time point. Third, to quantitatively assess potential bias from unmeasured confounding, we calculated the E-value. 31 Fourth, we examined the potential role of BC subtype, menopause status, self-identified race, and educational attainment as effect modifiers of the primary exposure–outcome association.

All statistical tests were 2-sided, and P  < .05 was considered statistically significant. All analyses were performed using SAS software, version 9.4 (SAS Institute Inc).

A total of 1340 women (mean [SD] age, 51.3 [9.9] years) enrolled in DELCaP and completed the baseline questionnaire ( Table ); most participants were postmenopausal (696 [52.5%]), self-identified as non-Hispanic White (1118 [83.7%]), completed at least some college education (954 [71.2%]), and were diagnosed with hormone-receptor positive BC (873 [65.3%]). During a mean (SD) follow-up time of 7.7 (2.1) years, 310 events of disease progression (23.1%) and 222 events of death (16.6%) occurred.

In univariable analyses assessing associations of participant characteristics at baseline with BC outcomes, age, menopause status, number of positive nodes, ERBB2 and hormone receptor status, tumor subtype, PA, smoking status, alcohol consumption, and the LIS were significantly associated with disease recurrence ( Table ). Similarly, age, educational attainment, menopause status, number of positive nodes, ERBB2 and hormone receptor status, tumor subtype, smoking status, and the LIS were significantly associated with mortality. In additional univariable analyses, the aggregated LIS was significantly associated with age, educational attainment, race, and number of positive nodes (eTable in Supplement 1 ). In Kaplan-Meier analyses, significant differences in disease-free (log-rank P  = 0.01 for trend) and overall survival (log-rank P <.001 for trend) according to LIS tertiles were observed, with strongest adherence associated with longer survival ( Figure 2 ).

Forest plots representing time-varying multivariable associations of the aggregated LIS with BC outcomes are presented in Figure 3 . Patients with the highest vs lowest LIS experienced significant reductions in recurrence (hazard ratio [HR], 0.63; 95% CI, 0.48-0.82). Although the association for the middle LIS tertile was not significant (HR, 0.83; 95% CI, 0.63-1.10), a significant dose-dependent association was observed ( P  < .001 for trend). Moreover, patients with an LIS in the middle and highest vs lowest tertile experienced significant reductions in mortality (HR, 0.70; 95% CI, 0.51-0.97 and HR, 0.42; 95% CI, 0.30-0.59, respectively; P  < .001 for trend).

In time-varying analyses for each lifestyle, partial and full adherence to the PA and smoking recommendations and full adherence to fruit and vegetable and sugar-sweetened beverage recommendations were associated with reduced disease recurrence; no statistically significant associations were observed for BMI, red and processed meats, or alcohol consumption ( Figure 3 A). Additionally, full adherence to PA, smoking, fruit and vegetable, and sugar-sweetened beverage recommendations and partial and full adherence to red and processed meat recommendation were associated with significant reductions in mortality ( Figure 3 B). For BMI, maintaining a normal weight was not significantly associated with mortality, but overweight was associated with significantly reduced mortality (HR, 0.71; 95% CI, 0.51-0.98). No statistically significant association was observed between alcohol consumption and mortality.

Multivariable associations of the LIS with BC outcomes at each time point (Q1-Q4) are presented in eFigures 2 through 5 in Supplement 1 , respectively. Highest vs lowest LIS was associated with reduced recurrence and mortality at Q1 (eFigure 2 in Supplement 1 ), reduced mortality at Q3 (eFigure 4B in Supplement 1 ), and reduced recurrence at Q4 (eFigure 5A in Supplement 1 ). Adherence to the smoking, PA, and red and processed meat recommendations were most consistently associated with outcomes at each time point (eFigures 2-5 in Supplement 1 ).

Leave-out analyses for disease recurrence revealed that adherence to the smoking recommendation at Q1 to Q3 and the PA recommendation at Q4 yielded the highest positive percent change in estimate when removed from the LIS ( Figure 4 A). However, for mortality, smoking status was the most important contributor to the LIS-mortality association at all 4 time points ( Figure 4 B).

In sensitivity analyses designed to assess the possibility of selection bias, differences in the 5-year survival of patients enrolled in DELCaP (88.0%) with patients enrolled in S0221 (89.0%) were negligible, with event rates of 0.026 and 0.023, respectively. 20 , 21 Minimal differences in successive response rates for Q1 to Q4 according to lifestyles were also noted. For example, patients with highest vs lowest LIS at Q1 were only slightly more likely to respond at Q2 (5.4%) and Q3 (3.9%), but negligible differences were observed at Q4 (0.4%).

Next, in quantitative analyses that assessed the role of unmeasured confounding, the E-values were 2.10 for disease recurrence and 3.03 for mortality. 31 Last, we found no evidence that the exposure-outcome association was confounded or modified by menopause status ( P  = .82 for interaction), race ( P  = .84 for interaction), educational attainment ( P  = .72 for interaction), or tumor subtype ( P  = .65 for interaction). For example, in subgroup analyses according to tumor subtype (eFigure 6 in Supplement 1 ), significant decreases in mortality were consistently observed for highest vs lowest LIS among patients with hormone receptor–positive, ERBB2 -negative tumors (HR, 0.45; 95% CI, 0.26-0.80), triple-negative BC (HR, 0.47; 95% CI, 0.29-0.76), and ERBB2 -positive tumors (HR, 0.25; 95% CI, 0.08-0.76).

In this prospective cohort study of adherence to cancer prevention guidelines before, during, and after treatment for high-risk BC, strongest adherence to cancer prevention lifestyle recommendations was associated with a 58% reduction in mortality and a 37% reduction in disease recurrence. Associations were not modified by educational attainment, self-identified race or ethnicity, or menopause status, and significant reductions in recurrence and mortality were consistently observed even among patients diagnosed with more aggressive BC subtypes.

Although the putative influences of diet, exercise, and smoking on the cellular processes underpinning the progression of BC have been extensively reviewed, 1 , 2 , 19 to our knowledge, this is the first report showing that lifestyles before, during, and after chemotherapy were associated with improved outcomes in patients with high-risk BC. Although no prior reports have described associations of an aggregated LIS from multiple time points with high-risk BC outcomes, our findings coincide with previous reports showing that healthier lifestyle scores are associated with better survival in patients diagnosed with a variety of tumors. 19 , 32 - 40

In examining the role of individual lifestyles, strongest adherence to recommendations for smoking, PA, fruit and vegetable intake, and sugar-sweetened beverage consumption were associated with significant reductions in recurrence and mortality. However, never smoking and meeting or exceeding the PA guidelines yielded the most consistent and robust associations with outcomes, with each factor associated with a 44% to 45% reduced hazard of mortality and a 35% reduced hazard of recurrence. These findings were confirmed in leave-out analyses, showing PA and smoking yielded the largest positive percent change in effect when removed from the LIS at each time point.

Conversely, strongest adherence to the alcohol and BMI recommendations was not significantly associated with improved outcomes, but overweight was associated with significantly improved survival. These findings are not entirely unexpected, because conflicting evidence and competing hypotheses regarding associations of alcohol and BMI with survival exist and associations may not be linear. 13 , 15 , 41 - 50 For example, overweight is often associated with improved BC survival in the extant literature (ie, an overweight paradox). 48 - 50 Although viable biological pathways have been proposed, methodologic issues, such as reliance on BMI as a proxy for adiposity or collider bias, may underly observed survival advantages among patients with overweight herein and in the literature. 48 - 51

Important strengths of our study include the large, well-characterized population of patients with BC, repeated lifestyle assessments using validated questionnaires, and the ability to control for treatment regimens. Importantly, incorporation of exposure data collected at multiple time points likely offset biases that could ensue from relying solely on prediagnosis or postdiagnosis exposures, which could be influenced by disease- and treatment-related symptoms.

The DELCaP Study included patients with BC enrolled in a clinical trial; thus, these findings may not be generalizable to more diverse clinical populations. Additionally, although we assessed the influence of measured and unmeasured confounders, we cannot rule out the possibility that residual confounding influenced our results. 21 We also cannot account for unmeasured factors (ie, quality of life after Q4) that may mediate the observed association between lifestyles and BC outcomes. However, the calculated E-values of 2.10 for disease recurrence and 3.03 for mortality reflect the minimum magnitude of association needed for unmeasured confounder(s) to have with both the exposure and outcome to explain away observed associations. 31 Given that HRs of 2- and 3-fold are not commonly observed in biomedical literature, an unmeasured variable that affects both the exposure and the outcome of interest by this magnitude would be even less common. 31

Moreover, because BC-specific survival was not tracked in S0221, the primary outcome is all-cause mortality. Consequently, we cannot account for comorbidities that may have developed after treatment completion, such as cardiovascular disease, a major competing cause of death among older patients with BC. 21 , 52 However, because patients with comorbidities, poor performance status, or a subnormal ejection fraction were excluded from S0221, competing causes of cardiovascular mortality may have been less likely to contribute to events in this study population. 21

We cannot rule out the possibility that selection biases (ie, healthy survivor bias) influenced our findings. However, in a series of sensitivity analyses, we found that differences in survival among patients enrolled in S0221 vs DELCaP were negligible. Moreover, there was no convincing evidence that patients with less healthy lifestyles were more likely to be lost to follow-up. Collectively, these analyses lessened our concern that a healthy survivor bias was at play.

Strongest collective adherence to cancer prevention recommendations before, during, and after treatment was associated with significant reductions in disease recurrence and mortality among patients with high-risk BC in the DELCaP Study. Strongest adherence to recommendations for smoking, PA, fruit and vegetable intake, and sugar-sweetened beverage consumption was most consistently associated with improved outcomes. Importantly, significant survival advantages were consistently observed in patients diagnosed with more aggressive BC subtypes.

Although strong evidence supporting the incorporation of smoking cessation and PA interventions during survivorship exists, additional confirmatory studies are needed to solidify the survival benefits of dietary and weight loss interventions. 53 - 55 Whereas expensive and potent therapeutics provide the foundation for BC treatment, lifestyle interventions could be a safe, inexpensive, and feasible ancillary strategy for delaying and preventing recurrence and death from the most common cancer in the world. Such developments could be especially impactful for patients diagnosed with more aggressive tumors that do not respond well to current therapies.

Accepted for Publication: March 20, 2023.

Published: May 4, 2023. doi:10.1001/jamanetworkopen.2023.11673

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2023 Cannioto RA et al. JAMA Network Open .

Corresponding Author: Rikki A. Cannioto, PhD, EdD, Department of Cancer Prevention & Control, Roswell Park Comprehensive Cancer Center, Elm & Carlton Streets, Buffalo, NY 14263 ( [email protected] ).

Author Contributions: Dr Cannioto had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Cannioto, Unger, Albain.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Cannioto, Hutson.

Critical revision of the manuscript for important intellectual content: Cannioto, Attwood, Davis, Mendicino, Zirpoli, Tang, Nair, Barlow, Hershman, Unger, Moore, Isaacs, Hobday, Hortobagyi, Gralow, Albain, Budd, Ambrosone.

Statistical analysis: Attwood, Davis, Mendicino, Hutson, Zirpoli, Tang, Barlow, Unger.

Obtained funding: Budd, Ambrosone.

Administrative, technical, or material support: Mendicino, Moore, Hortobagyi, Budd, Ambrosone.

Supervision: Cannioto, Budd.

PI of the observational study: Ambrosone.

Conflict of Interest Disclosures: Dr Barlow reported receiving grants from the National Cancer Institute during the conduct of the study. Dr Moore reported receiving grants from the Southwest Oncology Group and the National Cancer Institute during the conduct of the study and grants from AstraZeneca Research, Roche, Daiichi-Sankyo, Sermonix, and Seattle Genetics and personal fees from Myovant outside the submitted work. Dr Isaacs reported receiving personal fees from Genentech, PUMA, Seattle Genetics, Astra Zeneca, Novartis, Pfizer, Sanofi, Gilead, ION, Wolters Kluwer, McGraw Hill, SideOut Foundation, and Eisai and grants from GSK, Pfizer, SeaGen, AstraZeneca, BMS, Genentech, and Novartis outside the submitted work. Dr Gralow reported serving as a noncompensated member of independent data monitoring committees for Roche, AstraZeneca, and Novartis and serving on the SeaGen advisory board outside the submitted work. Dr Albain reported receiving personal fees from Novartis, Pfizer, Myriad Genetics, and Genomic Health Inc and serving on an independent data monitoring committee for Puma/Pfizer and Seattle Genetics outside the submitted work. No other disclosures were reported.

Funding/Support: This work was supported by grants R01 CA116395 (Dr Ambrosone), R01 CA139426 (Dr Ambrosone), P30CA016056, and T32CA113951 from the National Cancer Institute and The Breast Cancer Research Foundation (Dr Ambrosone). SWOG S0221 was supported in part by grants 5UG1CA189974-02, CA180888, CA180819, CA180863, CA180858, CA180828, CA180801, CA68183, CA04919, CA13612, and CA46282 from the National Cancer Institute and in part by Amgen Inc.

Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 2 .

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Introduction

External beam radiotherapy, cryoablation, factors favouring the use of radiotherapy, factors favouring the use of cryoablation, conflict of interest statement, funding sources, author contributions, treatment options for early stage inoperable breast cancer: cryoablation or radiotherapy.

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Gail Wan Ying Chua , Lucia Li; Treatment Options for Early Stage Inoperable Breast Cancer: Cryoablation or Radiotherapy?. Breast Care 15 April 2024; 19 (2): 106–114. https://doi.org/10.1159/000536413

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Background: Surgical removal of the tumour is the gold standard treatment for early stage invasive breast cancer. However, with a global ageing population, a larger number of diagnoses are occurring in women with comorbidities that render them unsuitable for surgery. Hence, it is of interest to explore alternative treatment strategies for this group of women. Summary: Our narrative review aims to explore two such techniques, cryoablation and external beam radiotherapy, providing a brief summary of the evidence behind each technique. Following this, we discuss which groups of patients would gain the most benefit from each technique. Factors favouring the use of radiotherapy include patients with larger tumours, more superficial tumours, and those with less well-demarcated tumours where there is uncertainty regarding tumour extent. Meanwhile, patients who may benefit more from cryoablation include those who desire a smaller number of treatment sessions, have concerns regarding cosmesis and skin pigmentation, or who have relative contraindications to radiotherapy such as scleroderma, systemic lupus erythematosus, reduced lung function, or cardiac comorbidities. Key Messages: Continued advancements in both cryoablation and radiotherapy technologies are taking place, in tandem with imaging technologies enabling greater certainty in tumour detection and delineation. These factors will help increase local control rates in this group of non-operable early stage breast cancer patients. Through this review, we hope to aid in the clinical decision-making process regarding the selection and referral of patients for each treatment.

Breast cancer is an increasingly common disease worldwide, making up nearly a quarter (24.5%) of all female cancers [ 1 ] with a lifetime risk of 1 in 8 among women in developed countries [ 2 ]. As the global population ages, a larger number of diagnoses will occur in women with comorbidities that render them unsuitable for surgery. Though surgical removal of the tumour remains the gold standard for early stage invasive breast cancer treatment, it is of interest to explore alternative means of treatment for the group of women who are at high operative risk. In this paper, we describe and compare 2 strategies, cryoablation and external beam radiotherapy, and analyse which group of patients may be more suited to receive either treatment. For our narrative review, we conducted a literature search of the electronic PubMed database. The search terms used included “cryoablation OR cryotherapy” AND “breast cancer OR breast adenocarcinoma,” as well as “radiotherapy OR radiation therapy” AND “breast cancer OR breast adenocarcinoma.” Studies with less than 5 years of follow-up (with the exception of interim analyses of phase 3 trials), and studies involving patients with metastatic breast cancer were excluded.

To date, the gold standard for treatment of early stage (T1–T2, up to 5 cm in size) node-negative breast cancer is surgical removal of the tumour, whether through wide excision with clear margins or mastectomy, together with sentinel lymph node biopsy [ 3 ]. For patients who undergo breast-conserving surgery, adjuvant radiotherapy is recommended in most cases; for patients aged 65 or older with hormone receptor-positive cancers compliant with endocrine therapy, radiotherapy may be omitted [ 4 ]. In patients with more aggressive subtypes such as triple-negative or HER2-positive tumours, neoadjuvant chemotherapy may be given [ 5 ]. For those not receiving neoadjuvant chemotherapy, chemotherapy following surgery may be recommended depending on factors such as HER2 expression or Oncotype Dx scores [ 6 ].

In patients being considered for surgical removal of their invasive breast tumours, preoperative risk stratification is essential. Various tools such as the American Society of Anaesthesiologists’ Physical Status Classification (ASA-PS), Physiological and Operative Severity Score for the enumeration of mortality and morbidity (POSSUM) score, and Revised Cardiac Risk Index (RCRI) [ 7 ], among others, are available to assess patients’ preoperative risk. In general, high-risk surgical patients are those with an individual mortality risk of greater than 5% [ 8 ]; these may include patients with a variety of comorbidities. For instance, cardiovascular conditions may include those such as unstable angina, congestive heart failure, previous stroke, or myocardial infarction within the last 3 months [ 9 ]. Patients with respiratory-related conditions such as chronic obstructive pulmonary disease or pulmonary fibrosis requiring oxygen supplementation may also be at higher perioperative risk [ 10 ]. Other conditions include history of poor wound healing due to poorly controlled diabetes or morbid obesity, resulting in a high anaesthetic risk. Frailty is a notable risk in an elderly population. Measurement scales of fraility include factors such as lean body mass, physical activity, and grip strength [ 11 ]; poorer scores are associated with greater post-operative complications and 30-day mortality [ 12 ]. In such situations, where the patient and surgeon deem the operative risk to be unacceptably high, alternative treatment strategies need to be considered. This paper discusses two such options, cryoablation and external beam radiotherapy.

External beam radiotherapy, utilising linear accelerator technology, has been commonly practised in the adjuvant and palliative settings for breast cancer. The cytotoxic effects of ionising radiation on rapidly dividing cancer cells result from the production of double-stranded breaks in DNA causing cell death, whether via apoptosis, necrosis, autophagy, replicative senescence, or mitotic catastrophe. Immunogenic effects may also contribute to the elimination of tumour cells both in the radiation field as well as distally [ 13 ]. Though recognised as standard treatment in the adjuvant or metastatic settings, the use of radiotherapy in the definitive treatment of breast cancer is less well described. Previous studies have used both conventionally fractionated and hypofractionated radiotherapy, and in more recent years, stereotactic ablative radiotherapy (SABR).

Classically, studies of radiotherapy for the radical treatment of breast cancer utilised multiple fractions over several weeks. For instance, Van Limbergen et al. [ 14 ] followed up on 221 patients with Tis-T3, N0-N1 breast cancer treated with definitive radiotherapy. The most common prescriptions were 40 Gy given over 4 weeks and 60–65 Gy given over 8–10 weeks to the whole breast, followed by a boost to the tumour site. The team reported a 75.4% local control rate after 15 years. Local failure risk increased by 8% per cm tumour diameter, and additional 10 Gy (T1 tumours) and 35 Gy (T2 tumours) doses of radiotherapy were needed to achieve local control similar to excision and radiotherapy. A larger study conducted by Arriagada et al. [ 15 ], involving 463 patients with breast cancer treated with radiotherapy alone, concluded that a dose increase of 15 Gy can result in a two-fold decrease in the relative risk of local recurrence. However, dose escalation beyond 75 Gy is limited by toxicity and poor cosmesis [ 16 ].

Recent advances in tumour delineation, such as via MRI planning and accurate radiotherapy delivery techniques, have led to an interest in accelerated partial breast irradiation after breast-conserving surgery for low-risk patients with early stage disease [ 17 ]; this allows the number of radiotherapy sessions to be significantly reduced while sparing a portion of the breast. Taking this one step further, SABR is also being explored for treatment of breast tumours. This technique is practiced commonly in the lung, prostate, and brain, allowing the definitive treatment of tumours without the need for surgery.

Several trials have investigated SABR for breast cancer; for instance, Bondiau et al. [ 18 ] conducted a phase I study using 5 dose levels for neoadjuvant breast cancer treatment. The pathological complete response rate was highest at 25.5 Gy/3#. Meanwhile, the Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer (ARTEMIS) study [ 19 ] aims to administer a dose of 40 Gy/5# every other day over 10–12 days, followed by lumpectomy. SABR-CaRe, a phase II randomised trial of preoperative SABR for early stage breast cancer, includes an arm with patients undergoing caloric restriction [ 20 ]. A good pathological response of tumours would support the option of definitive SABR for patients not able to undergo surgery. In addition, further advances in external beam radiotherapy techniques, such as proton therapy, may be successful in delivering higher doses with more tissue sparing. In a study investigating the dosimetric feasibility of early stage breast cancer treatment using both SABR and proton beam therapy by Lischalk et al. [ 21 ], overall target coverage of gross tumour and clinical target volumes was achieved while meeting dose constraints to vital structures such as the heart and lungs.

Cryoablation, a process where tumour cell kill is achieved via freezing, has also been explored for early stage breast cancer. It is a minimally invasive technique utilising one or more cryotherapy probes inserted under the skin under ultrasound or CT guidance, using local anaesthesia. Liquid nitrogen or pressurised argon gas is released, creating an ice ball that surrounds the tumour with a margin of at least 1 cm. During the subsequent freezing and thawing cycles, tumour cell death is achieved via ischaemia, cellular dehydration, coagulative necrosis, and apoptosis [ 22 ]. Separately, cryoablation can induce a systemic tumour-specific immunological response whereby cytokines released during cell death result in stimulation of cytotoxic lymphocytes, targeting microscopic metastases. In a murine model of breast cancer developed by Sabel et al. [ 23 ], cryoablation was shown to induce a tumour-specific T-cell response in surrounding lymph nodes as well as increased systemic NK cell activity. Low complication rates and overall favourable cosmetic outcomes have made cryoablation an attractive option for patients who are not candidates for surgical removal of their breast tumour [ 24 ].

Typical inclusion criteria for cryoablation include size of up to 2.0 cm, unifocality, ductal (rather than lobular) histology, absence of extensive intraductal component (EIC), and location greater or equal to 1 cm away from the skin surface [ 25 ]. Response to cryoablation can be determined either through subsequent surgical resection or imaging studies. An example of the former is found in the American College of Surgeons Oncology Group Phase II trial Z1072, where 86 evaluable patients with unifocal invasive ductal breast cancer smaller or equal to 2 cm underwent cryoablation. Surgical resection was performed within 28 days after cryoablation, and pathological examination showed successful ablation in 66 out of 87 lesions (75.9%). 100% of patients with tumours smaller than 1 cm in size had no residual invasive cancer on final pathology [ 26 ]. Likewise, an earlier study published in 2004 by Sabel et al. [ 21 ] showed the likelihood of success of cryoablation decreased with increasing tumour size. Among 27 patients undergoing cryoablation followed by surgical resection one to 4 weeks later, patients with breast tumours smaller than 1.0 cm had a 100% pathological response rate, but for the group of patients with tumours 1–1.5 cm, complete response was only achieved in those without a significant ductal carcinoma in situ (DCIS) component, and the authors concluded the technique was “not reliable” for patients with tumours >1.5 cm. Meanwhile, Machida et al.’s team [ 27 ] investigated serial imaging findings after cryoablation for early stage breast cancer, without surgery. Out of 54 patients, 7 showed suspicious areas on the first follow-up MRI, but these had resolved by the second follow-up MRI. 1 patient out of 54 experienced ipsilateral recurrence and underwent mastectomy.

Two phase 2 trials, ICE3 (NCT02200705) [ 28 ] and FROST (NCT01992250) [ 29 ], are in progress, aiming to evaluate response rates of cryoablation without surgery in patients with invasive breast cancer ≤1.5 cm. The FROST trial will evaluate residual viable invasive or in situ carcinoma via biopsy at 6 months post-procedure, while the primary outcome of ICE3 is ipsilateral breast tumour recurrence at 5 years. For the latter, a 3-year interim analysis was recently published in August 2021 [ 30 ]. At a mean follow-up duration of 34.83 months, the ipsilateral breast tumour recurrence rate was 4/194 (2.06%), with no severe adverse events and 95% of patients reporting satisfaction with their cosmesis.

Aside from cryoablation, several other ablative methods have been utilised for the treatment of non-operable early stage breast cancer [ 31 ]. For instance, radiofrequency ablation, high-intensity focused ultrasound, microwave ablation, and laser ablation all utilise heat-induced coagulation necrosis. Similar to cryoablation, most of these have been utilised for smaller tumours under 2 cm in size with minimal associated DCIS. Complications include pain, skin burns, and hyperpigmentation. Advantages of cryoablation compared to heat-based ablative techniques include better preservation of the tissue collagen matrix, resulting in better cosmesis; better tolerability due to the intrinsic anaesthetic effects of low temperatures [ 32 ]; and possible increased stimulation of the immune response [ 33 ].

Larger Tumours

Most trials utilising cryotherapy for early stage breast cancer have stipulated a maximum clinical tumour size of 2 cm as inclusion criteria. Some barriers to treating larger-sized tumours include technical limitations of ice ball formation with the cryoprobe, as well as uncertainty about the extent of EIC and ability to obtain adequate margins with larger tumours [ 34 ]. While Littrup’s team was able to treat tumours up to 5.8 cm with a multi-cryoprobe technique, the study team also recognised that accuracy of imaging using MRIs, as well as competent ultrasound-guided ablation were crucial to the success of the procedure; the 50% of patients with bulky tumours had additional CT guidance during the ablation procedure which may not be available in all centres [ 35 ]. Other available literature suggests that cryoablation is effective for tumours up to only 1.5 cm [ 36‒38 ]. Sabel et al.’s team showed a 100% pathological response rate at subsequent surgical resection for patients with tumours up to 1.0 cm but only a 71% response rate for tumours >1.5 cm. Taking these into consideration, the ICE3 [ 28 ] and FROST [ 29 ] trials take a conservative approach, including patients with tumours not larger than 1.5 cm.

In contrast, for tumours larger than 1.5 cm, radiotherapy can still be utilised effectively. In studies using conventional fractionation, the whole breast was included in the radiotherapy field, ensuring that the tumour received some dose coverage regardless of size or location within the breast. A boost dose was then added to the tumour itself, and this boost could be increased with increasing size of tumour, as long as doses to organs at risk were within constraints and side effects remained well tolerated for the patient. Van Limbergen’s team, investigating radical radiotherapy to the whole breast followed by tumour boost, was able to achieve control rates similar to surgery and adjuvant irradiation (95% at 5 years for T1 tumours and 90% at 5 years for T2 tumours) by utilising a correspondingly higher dose for T2 tumours [ 14 ]. Likewise, Arrigada et al. [ 39 ] showed that while larger tumour size was related to poorer local control, this could be compensated for by increasing tumour dose, and in fact, tumour dose was more significant than size in predicting local tumour control. More recently, larger breast tumours have been successfully treated by radiotherapy with the use of radiosensitization techniques. For instance, Shibamoto et al. [ 31 ] utilised two alternative radiosensitization techniques for tumours ≥2 cm in diameter: (1) hydrogen peroxide injections prior to whole breast radiotherapy, and (2) hyperthermia plus oral tegafur-gimeracil-oteracil potassium. Among a total of 45 patients, the majority of whom were stage I and II, good 5-year overall survival (97.3%) and local control rates (87.9%) were achieved. All in all, for larger tumours – greater than 1.5 cm, or T2 tumours, radiotherapy may be a more effective treatment compared to cryoablation due to the option of increasing prescribed radiotherapy dose with increasing tumour size, as well as the availability of radiosensitization methods.

Recent studies evaluating radiotherapy for the treatment of early stage breast cancer aim to give localised treatment with shorter fractionation schedules. Inclusion criteria are more generous in terms of size as compared to studies using cryoablation; for instance, the ABLATIVE study, evaluating single-dose radiotherapy for early stage breast cancer, has stipulated a maximum tumour size of 3.0 cm on diagnostic MRI. 20 Gy in a single fraction is prescribed, equivalent to 73.7 Gy equivalent dose in 2 Gy fractions [ 17 ]. Likewise, the SABR-care study [ 20 ], studying a 5-fraction, alternate-day, SABR procedure, includes breast tumours up to 3.0 cm on imaging. While results from these studies are still awaited, the technical feasibility of delivering stereotactic radiation to T2 breast tumours is certainly proven. Thus, for patients with tumours between 1.5 and 3.0 cm who are unsuitable for surgery, more options are available for enrolment on radiotherapy trials as compared to trials utilising cryoablation.

Superficial Tumours

Due to the ice-ball formation technique used in cryoablation and the requirement of ideally obtaining a margin of 1 cm around the tumour, patients with more superficial tumours are at higher risk of adverse hypothermia effects to the pectoralis muscle or skin, leading, in extreme cases, to necrosis [ 40 ]. As a result, most guidelines suggest that tumours should be located at least 1 cm below the skin surface [ 41, 42 ]. While teams such as Cazzato et al. [ 43 ] accepted patients with cancers located as close as 5 mm to the skin, saline solution was injected into subcutaneous tissue to create further separation between the ice ball and the skin. Toxicities included “haematoma coupled with skin retraction” as well as “skin burn.” Despite best efforts during the ultrasound-guided procedure to ensure the tumour is accurately treated, Pusceddu et al. [ 40 ] report that there is still “low capability of limiting the ablation area”; thus patients with more superficial tumours may not be good candidates for cryoablation due to higher risk of skin toxicity.

In contrast, more superficial breast tumours are more amenable to treatment with radiotherapy. While photons used in radiotherapy treatment are known to have a skin-sparing effect [ 44 ], lower-energy radiotherapy beams, for instance, 6 MV instead of 10 MV photons, can be utilised to obtain better dose coverage for superficial tumours [ 45, 46 ]. In some cases, an electron boost following photon radiotherapy can be given [ 47 ]. A bolus is often used to increase dose to the skin in patients undergoing post-mastectomy radiotherapy or with superficial chest wall lesions. However, with the availability of modern linacs using flattening filter-free photon beams, superficial dose can be further increased without the need for a bolus [ 48 ], thus minimising the risk of adverse skin side effects for patients with tumours in situ. Shibamoto et al. [ 49 ] delivered radical treatment utilising whole breast irradiation followed by IMRT boost to a patient with a tumour located just beneath the nipple; treatment was reported to be well tolerated. While the risk of acute dermatitis remains a possibility in radiotherapy, most cases can be managed with supportive treatment such as moisturisers [ 50 ]; on the other hand, the potential thermal injury and ulceration resulting from cryoablation-induced skin toxicity may require more intensive medical management and last for a longer duration [ 51 ].

Uncertainty regarding Extent of Tumour

Several factors, including multifocality, EIC, and invasive lobular histology, render it more difficult to determine the exact extent of the tumour. For patients with such tumours undergoing cryoablation, there is an increased risk of there being remnant disease outside of the ablation zone. For instance, in the Phase II ACOSOG Z1072 trial studying cryoablation of early stage breast tumours, successful ablation was achieved in 80 out of 87 patients (92.0%) when multifocality was not taken into consideration. However, 14 of these patients had residual foci of disease beyond the ablation zone, accounting for these patients, ablation success rate fell to 75.9%. The team concluded that multifocal disease may be a limiting factor in the effectiveness of cryoablation alone and suggested it should be combined with adjuvant radiation [ 26 ].

Meanwhile, Sabel et al. specified multifocal, non-calcified DCIS as “the most challenging issue” for ablative techniques. The authors recommended excluding patients with more than minimal calcifications, as the true size of DCIS is frequently underestimated by measuring the extent of microcalcifications on mammography alone. After patients in Sabel’s study underwent cryoablation and surgery, 4 out of 27 patients were found to have residual DCIS in the normal tissue around the cryoablation zone. When Sabel further stratified patients by histology, 3 patients with invasive lobular and 2 with colloid carcinoma underwent the cryoablation procedure; out of these 5, 3 had remnant invasive cancer, and initial ultrasound was shown to have significantly underestimated the final size of the tumour. Due to difficulty in measuring the true size of tumours on initial scans, patients with invasive lobular histology have typically not been candidates for ablation procedures [ 52 ].

On the other hand, radiotherapy can be used to treat breast tumours that are less “well-defined.” For instance, in a study [ 53 ] treating 38 patients radically with whole breast radiotherapy with stereotactic or IMRT boost, a local control rate of 92% was achieved at 3 years, with the caveat that chemotherapy and hormones were also allowed in the study. Patients with invasive lobular carcinoma, EIC, or multifocal tumours were not excluded and patients with lymph node metastases were also eligible. The Institut Gustave-Roussy study, treating breast cancer patients with radiotherapy alone, likewise did not specify limitations of histology or multifocality and even included patients with advanced, inflammatory tumours. While overall 5-year local control was poor at only 56%, patients with small tumours <4 cm, albeit unfit for surgery, had a much better 5-year local control rate of 85% [ 16 ]. One advantage of radiotherapy in treating more diffuse tumours is the presence of the dose gradient surrounding the target volume. This ensures the edges of the tumour will not experience a sharp dose fall off. Furthermore, the size of the clinical target volume and planning target volume can be expanded by the clinician during radiotherapy planning, if there is insufficient confidence regarding the tumour borders.

However, as the radiotherapy field moves towards using focal or SABR to treat early stage breast tumours in surgically ineligible patients, more caution needs to be taken, and different trials have varying inclusion criteria. For example, the prospective, single-arm ABLATIVE study, investigating single fraction MRI-guided radical radiotherapy treatment, excludes patients with EIC, pure lobular, and multifocal tumours [ 17 ]. However, the SIGNAL trial, investigating 21 Gy/1# versus 10 Gy/3# for early stage breast cancer followed by lumpectomy, has multifocality as an exclusion criteria, but lobular carcinoma are included and EIC is not mentioned [ 54 ].

At present, for surgically unfit patients with early stage breast tumours that fall into the “harder to demarcate” category – multifocal, invasive lobular tumours or those with EIC, we would recommend radiotherapy to the whole breast with a boost to the tumour using CT- or MRI-guided planning rather than partial breast or SABR, or cryoablation. However, this conclusion can be revisited in the future, assuming imaging techniques continue to improve, and it becomes easier to demarcate the extent of tumours with greater certainty.

Improved Cosmetic Outcomes

Side effects of cryoablation include skin or fat necrosis, infection, swelling, and pain; however, most resolve over the short term [ 40 ]. While few studies have specifically investigated cosmetic outcomes for patients receiving cryoablation for early stage breast cancer, results can be extrapolated from previous studies using the same technique to treat benign breast lesions; for instance, Kaufman et al. [ 55 ] treated 78 benign breast lesions with cryoablation, achieving patient satisfaction rates of 92% reporting “good to excellent”; no volumetric deficit was observed, and only a small scar was visible at the cryoprobe insertion area. Similarly, in a 3-year outcome report of the ICE3 trial, over 98% of treating physicians and over 95% of patients were satisfied with the cosmetic outcome [ 30 ].

On the other hand, radiotherapy sequelae such as hyperpigmentation and fibrosis tend to persist for the long term and can be permanent. Such effects can be worse for patients who receive higher doses of radiotherapy; for instance, Van Limbergen’s team reported a dose-response curve corresponding to increased radiation fibrosis with increased total dose from 40 Gy upwards, and for patients who received more than 80 Gy, only 15% had a good cosmetic outcome [ 56 ]. Likewise, Calle et al.’s [ 57 ] team delivered doses up to 85 Gy with only 38% patients reporting good cosmesis at 5 years. More recently, SBRT techniques have resulted in more sparing of normal tissue. However, with larger fraction sizes, risk of late-normal tissue toxicity increases. For instance, in the FAST-forward trial, the 27 Gy in 5 fractions arm showed increased toxicity compared to the slightly lower 26 Gy dose [ 58 ]; this study was done on patients receiving adjuvant radiotherapy after tumour excision; for non-operable patients with tumours in situ, a higher dose would be required for local control, leading to potentially worse cosmetic outcomes. In Shibamoto’s study of patients receiving radical whole breast radiotherapy with SBRT or IMRT boost, asymmetry of the breasts was reported as an adverse outcome [ 53 ]. Finally, should patients be eligible for and require surgery in the future, breast irradiation may lead to poorer post-operative outcomes such as delayed wound healing [ 59 ].

Reduced Number of Treatments

While external beam radiotherapy is non-invasive, it requires multiple visits by the patient; a simulation scan needs to be done, followed by the radiotherapy treatment sessions themselves. Using conventional fractionation to deliver a radical dose would necessitate around 5 or more weeks of daily treatment. With accelerated partial breast irradiation or SBRT, number of treatment fractions can be reduced, and treatment may be completed within a single week [ 60 ]. However, radiotherapy would still require more visits than cryoablation, which can typically be done within a single session as an outpatient procedure. After the simulation scan is performed, radiotherapy planning is done over several days, following which quality checks are done. In some cases, changes that occur in between simulation and the start of treatment, or during the course of radiotherapy treatment, may necessitate a repeat simulation and replanning process, such issues include weight loss, development of seromas, or difficulty reproducing the treatment position due to injury [ 61 ]. Thus, for patients who prefer to complete their treatment over a shorter period of time and avoid the more lengthy process of radiotherapy simulation, planning, and multiple visits for treatment, cryoablation may be the preferred option.

Patients with Relative Contraindications to Radiotherapy

A group of patients who may benefit more from cryoablation may be those with relative contraindications to radiotherapy, for example, patients with systemic lupus erythematosus. In a study conducted by the Mayo Clinic, 21% of systemic lupus erythematosus patients had acute radiotherapy-related toxicity of grade 3 or worse, while 40% had chronic toxicity of grade 3 or worse [ 62 ]. Meanwhile, case series of patients with scleroderma indicate greater risk of fibrosis of the breast that received radiotherapy [ 63 ]. In a study on scleroderma patients receiving breast RT in Johns Hopkins and Pittsburgh [ 64 ], between 48.4 and 54.6% of patients had skin thickening in the radiotherapy field, but no evidence of lung toxicity or disease flare was observed.

Other relative contraindications to radiotherapy include cardiac or pulmonary comorbidities. For instance, Van der Bogaardt et al. [ 65 ] found a 16.5% increase in coronary events for each Gy of mean heart dose, in patients treated with 3D conformal radiotherapy for breast cancer. Similarly, McGale et al. [ 66 ] reported a higher frequency of cardiac events – for example angina, pericarditis, myocardial infarction – in patients receiving radiotherapy to the left breast, in particular, patients with pre-existing cardiac comorbidities. This cardiac risk from radiotherapy, however, is mitigated somewhat if smaller volumes can be targeted (e.g., via SABR or partial breast irradiation).

Meanwhile, radiation pneumonitis may develop in 1–10% of patients receiving breast radiotherapy, most commonly occurring 3–6 months post-radiotherapy [ 67 ]. Menhati et al.’s [ 68 ] team found a drop in FEV1 at 3 and 6 months post-radiotherapy; though this did not manifest in significant increases in clinical symptoms, authors concluded that performing baseline pulmonary function tests could help identify patients at higher risk of pulmonary toxicity. Overall, studies show the risk of radiation pneumonitis and radiation-induced cardiac events increase in a dose-dependent fashion [ 69, 70 ]. For this cohort of non-operable patients, the dose required for radical treatment of breast cancer is correspondingly higher than that required in the post-operative setting; hence, for the portion of patients who are unfit for surgery due specifically to existing cardiac or pulmonary comorbidities, opting for cryoablation over radiotherapy may well be the safer option.

Finally, other circumstances whereby patients would be advised to choose cryoablation over radiotherapy would include patients who had received prior thoracic radiotherapy to the same area [ 71 ] or patients with DNA repair deficiencies, such as TP53 mutations, which increase the risk of secondary cancers following radiotherapy [ 72 ].

Ultimately, both radiotherapy and cryoablation have limitations for treatment of non-operable breast cancer, and not all patients are suitable for these techniques. For those lacking accurate imaging techniques, e.g., high-quality diagnostic mammography or MRI scans, biopsy site markers, or CT guidance during the procedure, success of cryoablation may be reduced [ 35 ]. For patients without access to radiosensitization techniques, tumours exceeding 3 cm may prove challenging to control with radiotherapy, without compromising cosmesis or acceptable tissue toxicity. For patients undergoing either treatment strategy, regular follow-up with clinical examination, annual mammograms, and/or breast MRIs is advisable. In addition, the treating physician should closely monitor for the potential development of nodal or distant metastases [ 73 ].

For the cohort of non-operable patients with early stage breast cancer, both cryoablation and external beam radiotherapy are valid options to consider. For patients with larger, less well-demarcated tumours, e.g., those with invasive lobular histology or a significant DCIS component, radiotherapy may provide better local control. On the other hand, for patients with cardiac or pulmonary comorbidities who are at risk of adverse effects from high-dose radiotherapy or for those who desire a smaller number of treatment sessions, cryoablation may be the preferred option instead. Cryoablation may provide a favourable cosmetic outcome with the option to repeat the procedure in the future, while external beam radiotherapy is a non-invasive procedure with the possibility of dose escalation, especially for larger tumours. Newer technologies, such as SABR or proton therapy, may enable greater sparing of normal tissues as well.

Continued advancements in both cryoablation and radiotherapy technologies are taking place, in tandem with imaging technologies enabling greater certainty in tumour detection and delineation; all in all, these may well help to increase local control rates in this group of non-operable patients unfit for definitive surgical excision of their breast cancer.

The authors have no conflicts of interest to declare.

No funding was received for this review.

All authors have made substantial contributions to the conception and writing of this manuscript.

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New study finds triple-negative breast cancer tumors with an increase in immune cells have lower risk of recurrence after surgery

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By Kelley Luckstein

A new multicenter, international study suggests that people who have early-stage  triple-negative breast cancer  (TNBC) and high levels of immune cells within their tumors may have a lower risk of recurrence and better survival rates even when not treated with chemotherapy. The  study  was published today in the Journal of American Medical Association (JAMA).

TNBC is a breast cancer subtype that does not respond to drugs that target the estrogen receptor or the HER2 protein. It grows rapidly, is more likely to spread beyond the breast before diagnosis and is more likely to recur than other breast cancers. TNBC represents about 15% of all breast cancers and is more common in younger people and in women of African American, Hispanic and Indian descent. Immune cells, also known as tumor-infiltrating lymphocytes, or TILs, are naturally existing immune system cells that can move from the bloodstream into a tumor and can recognize and destroy cancer cells.

"This is an important finding because it highlights that the abundance of TILs in breast tissue is a prognostic biomarker in people with early-stage triple-negative breast cancer, even when chemotherapy is not administered," says  Roberto Leon-Ferre, M.D. , a breast medical oncologist at  Mayo Clinic Comprehensive Cancer Center  and first author of the study. "The study's findings may inspire future clinical trials to explore whether patients with a favorable prognosis (high TILs) can avoid intensive chemotherapy regimens."

"This meta-analysis confirms robustly the prognostic value of TILs that we have previously reported in TNBC patients treated with chemotherapy and expands it to patients treated without chemotherapy," says Sarah Flora Jonas, Ph.D., a statistician at  Gustave Roussy  and co-first author of the study. "Future studies may allow the use of this biomarker along with standard clinicopathological factors to inform treatment decisions in TNBC patients."

"Of interest, the first report suggesting that an increased number of immune cells being associated with better prognosis in breast cancer patients was described by doctors at Mayo Clinic more than 100 years ago," says Roberto Salgado, M.D., co-chair of the International Immuno-Oncology Biomarker Working Group; co-lead of the study; and pathologist from the Peter MacCallum Cancer Centre, Melbourne, Australia, and ZAS Hospitals, Antwerp, Belgium. "It took a global effort and a century later to reexamine this biomarker and bring it closer to application in patient care."

"TILs are not currently measured or reported in the routine examination of tissue samples of breast cancer," says co-senior author,  Matthew Goetz, M.D. , a medical oncologist at Mayo Clinic Comprehensive Cancer Center and the Erivan K. Haub Family Professor of Cancer Research Honoring Richard F. Emslander, M.D. "While prior studies have focused on measuring TILs in people treated with chemotherapy, this is the largest study to comprehensively demonstrate that the presence of TILs influences the natural behavior of breast cancer in people who have surgery and/or radiation with no additional medical treatment."

For this study, Mayo Clinic and Gustave Roussy researchers, in collaboration with the International Immuno-Oncology Biomarker Working Group, led 11 additional groups to collect data on 1,966 participants with early-stage TNBC who only underwent surgery with or without radiation therapy but did not receive chemotherapy. The participants had been followed for a median of 18 years. The results showed that higher levels of TILs in breast cancer tissue were associated with lower recurrence rates among participants with early-stage TNBC.

"Five years after surgery, 95% of participants with small tumors, stage 1 TNBC, and whose tumors had high TILs were alive, compared to 82% of patients whose tumors had low TILs. Importantly, the breast cancer recurrence rate was significantly lower among patients whose tumors had high TILs," says co-senior author,  Stefan Michiels, Ph.D. , head of Oncostat team, Gustave Roussy, Inserm U1018, University Paris-Saclay. "With nearly 2,000 participants involved in the study, we have now assembled the largest international cohort across three continents of people with TNBC in which the primary treatment was surgery without chemotherapy."

"The results of this study could lead to a recommendation to include TILs in the pathology reports of early-stage TNBC worldwide, as it has the potential to inform clinicians and patients when they discuss treatment options," says Dr. Salgado.

Furthermore, this biomarker would only require a visual evaluation by a pathologist looking through a microscope, meaning there are no additional costs associated with identifying the presence of immune cells. This could be particularly beneficial to regions with limited resources, adds Dr. Leon-Ferre.

Most people with early-stage TNBC undergo chemotherapy either before or after surgery, including people with stage 1 breast cancer. Most people receive multiple chemotherapy drugs in combination, which can cause significant side effects. Currently, the main factors considered to determine the course of chemotherapy treatment for each person are the tumor size and whether the cancer has spread to the lymph nodes. However, the authors identified that the number of TILs further influences the risk of future recurrence.

The researchers plan to evaluate TILs as biomarkers in prospective clinical trials evaluating chemotherapy selection based on TIL levels. Ongoing efforts to conduct additional research with other potential biomarkers are underway.

For a complete list of authors, disclosures and funding, see the full paper  here .

Learn more about breast cancer and find a clinical trial at Mayo Clinic.

Join the Breast Cancer Support Group on Mayo Clinic Connect , an online community moderated by Mayo Clinic for patients and caregivers.

Also, read these articles:

• Understanding triple-negative breast cancer and its treatment
• 17-gene signature linked to remission after triple-negative breast cancer treatment

A version of this article was originally published as a press release on the Mayo Clinic News Network .

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