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Third Symposium on Primary Breast Cancer in Older Women Theme: Personalising the management of primary breast cancer in older women East Midlands Conference Centre Nottingham 6 March 2015 Under the auspices of:

Accredited by the Royal College of Surgeons of England for up to 5 CPD points

Information to delegates: Wifi: Is available free of charge in the East Midlands Conference Centre Programme, speakers’ http://www.futuremedicine.com/toc/fon/11/4s  profiles and abstracts: Slides: Copies of the slides presented at the Symposium will be available until the end of March via the cloud at: ftp://ftp.nottingham.ac.uk/pub/Projects/3rd_ symposium_slides Useful links: University of Nottingham www.nottingham.ac.uk   International Society of Geriatric www.siog.org Oncology (SIOG)   Breast Cancer Care www.breastcancercare.org.uk Evaluation forms: Please hand in your completed ‘Evaluation form’ to the Registration Desk at the end of the Symposium in exchange for your ‘Certificate of Attendance’.

10.2217/FON.15.40 © 2015 Future Medicine Ltd

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Supplement  Welcome message We would like to offer a very warm welcome to the ‘Third Symposium on Primary Breast Cancer in Older Women’. As you know this is the third meeting of this kind, following its inception in 2010 [1] . Since last time (2013), the event has been hosted by the University of Nottingham under the auspices of the International Society of Geriatric Oncology (SIOG). On this occasion, it is our honor to have Dr Etienne Brain, President of SIOG, in the faculty, which continues to be multidisciplinary, also including a geriatrician for the first time. We have named this event as a symposium and also for the first time, included poster presentations with all accepted abstracts published in a peer-reviewed journal (Supplement to Future Oncology). Objectives:

With the theme ‘Personalising the management of primary breast cancer in older women’, this Symposium has the following specific objectives: ●● To develop an in-depth understanding around the biology and treatment options ●● To explore the specific physical and psychosocial needs and consideration including patients

perspective ●● To gain insight into the development of a holistic and multidisciplinary management approach

and the importance of supporting research Formats:

Lectures from external and local faculty with a number of interactive discussions, sharing of patients’ experience, and poster presentations. We are indebted to our sponsors and would encourage you to visit their stands between sessions. We hope that you will enjoy the day and the interactions with one another, including our patients during the meeting.

Mr KL Cheung Co-chair

Dr DAL Morgan Co-chair

Reference 1

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Cheung KL, Ellis IO, Morgan DAL et al. Optimising the management of primary breast cancer in older women – a report of a multi-disciplinary study day. Breast 20, 581–584 (2011).

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Programme: Arrival and registration Welcome and introduction (09:45–10:00): Mr KL Cheung Session 1 Biology and clinical relevance (10:00–11:15); Chair: Dr DAL Morgan 10:00–10:25 10:25–10:40 10:40–11:05 11:05–11:15

Biological differences in the older population Differing biology and clinical relevance Decision of systemic treatment for use in an adjuvant setting Discussion

Professor SE Pinder Mr KL Cheung Dr E Brain Panel

Coffee break and poster viewing (11:15–11:40) Session 2 Local therapies (11:40–12:45); Chair: Mr KL Cheung 11:40–12:05 12:05–12:30 12:30–12:45

The influence of frailty, co-morbidity and dementia on surgical treatments Intra-operative radiotherapy – the TARGIT trial data Discussion

Ms L Wyld Professor J Tobias Panel

Lunch break and poster viewing (12:45–13:45) Session 3 Patients perspectives (13:45–15:15) Chair: Dr E Brain 13:45–14:10

Listening to the patient – Interview of a few patients

14:10–14:35

Age is just a number: why it is important to consider the older women’s experience and their psychosocial needs? Patient-related factors associated with treatment and outcome Discussion

14:35–15:00 15:00–15:15

Mrs H Stone and Mrs L Winterbottom Dr P Harris Dr E Bastiaannet Panel

Coffee break and poster viewing (15:15–15:40) Session 4 Challenges and future directions (1540–1645) Chair: Mr KL Cheung 15:40–16:05 16:05–16:30 16:30–16:40 16:40–16:45

The role of the geriatrician Specific trial methodology and endpoints Discussion Conclusion – summary and ways forward

Dr S Rostoft Dr E Brain All faculty Dr DAL Morgan

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Acknowledgements: The ‘Third Symposium on Primary Breast Cancer in Older Women’ has been supported by the following companies, to whom we are grateful:

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Speakers’ profiles Esther Bastiaannet

Esther Bastiaannet is a senior epidemiologist at the geriatric oncology research group in Leiden, The Netherlands. The main focus of her research is on breast and colorectal cancer in older patients, international comparisons and methodology in geriatric oncology research. She was a visiting research fellow at the department of senior adult oncology at H. Lee Moffitt Cancer Center and Research Institute (FL, USA) from March to August 2014. Etienne Brain

Etienne Brain, MD PhD, is a medical oncologist working at Hôpital René Huguenin/Institut Curie in Saint-Cloud, France. He serves as officer in UNICANCER and EORTC groups (breast cancer, EORTC Cancer in the Elderly Task Force, GERICO group). His research covers breast cancer and geriatric oncology, focusing on competing risks for mortality in older breast cancer patients, as embodied in the national program ASTER 70s granted in 2011 by the French health ministry. He is (co)author of several publications in peer-reviewed journals, including the JAMA, Lancet Oncology and Journal of Clinical Oncology. He is member of the Editorial Board of the Journal of Geriatric Oncology. He is an active member of ASCO and ESMO. He is a full member of SIOG since 2006 and has been appointed president in Lisbon in October 2014. Kwok-Leung Cheung

Kwok-Leung Cheung qualified and trained in Hong Kong, was appointed as Consultant Breast Surgeon, Nottingham University Hospitals in 2001. He joined the University of Nottingham in 2004. In 2011, he became a member of the Derby Breast Unit. In 2007 he was selected as an International Guest Scholar of the American College of Surgeons. He is part of the UK National Cancer Peer Review team, and also a member of a number of national and international societies, including the International Society of Geriatric Oncology where he is currently the UK National Representative and a member of the Surgical Task Force. Perlita Harris

Perlita Harris was diagnosed with breast cancer in 2009 and is a member of UK Charity Breast Cancer Care Service User Research Partnership. Perlita has been a research participant in several breast cancer-related research studies, including a doctoral ethnographic study that filmed her life over a 6-month period. Perlita is a registered social worker with a background in adoption support, holds a PhD in Social Work, and is a Lecturer in Social Work at Goldsmiths, University of London. Perlita’s research interests focus on adoption, child welfare and service user perspectives, particularly black, LGBT and seldom heard voices. She was a member of the ‘Coming out about breast cancer’ steering group, and co-authored the guide: Supporting Lesbian, Gay, Bisexual And Trans People With Cancer: A Practical Guide For Cancer And Other Health Professionals (Fish and Harris 2012). Perlita is committed to service user involvement in social work practice, education and research. David AL Morgan

David AL Morgan is a Radiation Oncologist and co-founder of Nottingham’s multidisciplinary clinic for the management of older patients with primary breast cancer. He has a career-long interest in breast cancer and belief in the need to empower patients in treatment decision-making, has been active in numerous national and international committees, has been a contributor to many major clinical trials, and has collaborated closely with the University of Nottingham’s Translational Radiation Biology Research Group. He has an extensive list of publications in these various areas, as well as other fields of Oncology.

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Supplement  Speakers’ profiles (cont.) Sarah Pinder

Sarah Pinder undertook her medical degree at Manchester University and, following histopathology training and research, and Senior Lecturer/Consultant posts in Nottingham and then Cambridge, is Chair of Breast Pathology at Kings College London. She is also Head of Department of Research Oncology, in the Cancer Division, at King’s College London. She is a Lead Specialist Breast Pathologist at Guy’s and St Thomas’ Hospitals/King’s Healthcare Partners and has a large referral practice in addition to the ‘routine’ NHS histopathology workload. Her research interests are also focused on breast cancer pathology (both in situ and invasive), with emphasis on correlation of morphology with protein expression and molecular and genomic features. Features that predict the behavior of this very clinically and biologically variable disease are investigated through genomic, molecular and histological techniques. She has published over 230 articles in peer-reviewed literature, approximately 50 invited review articles and 50 chapters in textbooks. She serves on the NHS Breast Screening Pathology Coordinating Committee (and Chairs the Research Sub-Group) and the Sloane Project (National UK DCIS audit) Steering Group, as well as being a member of various clinical trial and translational research committees. Siri Rostoft

Siri Rostoft is a medical doctor at Oslo University Hospital, Norway, specialized in internal medicine and geriatric medicine. She completed her PhD on geriatric assessment in older surgical cancer patients in 2011. Her main research interests in geriatric oncology are the clinical importance of geriatric assessment and interventions and frailty. She is a deputy editor for Journal of Geriatric Oncology. Heather Stone

Heather Stone qualified as a Registered Nurse in September 1987 following 3 years’ training at Harefield, Hillingdon and Mount Vernon Hospitals. She has predominately worked in the surgical setting taking up Staff Nurse posts on a mixed surgical ward at Mount Vernon Hospital, Harefield ITU and a cardio-thoracic ward at Kings College Hospital, London. In 1991, she trained as a midwife at Kings College Hospital, London, qualifying in 1992. Following a move to Derby in that same year she returned to nursing, firstly as a District Nurse then hospital-based at the Derby City Hospital now re-named The Royal Derby Hospital. She joined the breast unit at the Royal Derby Hospital in Sept 2002 as a breast care nurse, where she has remained in post, being promoted to Lead Specialist Nurse in January 2013. Jeffrey Tobias

Professor Jeffrey Tobias qualified in medicine from Cambridge University and St Bartholomew’s Hospital in 1971. After joint specialist training in medical and clinical oncology at St Bartholomew’s, UCH, the Royal Marsden Hospital and Harvard Medical School, he became a Consultant in Clinical Oncology at UCH/Middlesex Hospitals in 1981. His main interests are in clinical research into innovative treatment methods, especially in breast cancer, and in the ethical issues surrounding large-scale cancer trials.

Linda Winterbottom

Linda Winterbottom is an Advanced Nurse Practitioner at Nottingham University Hospitals. Linda has a long history of working as a CNS (Clinical Nurse Specialist) in Breast Care at Nottingham Breast Institute. Starting as a Research Nurse in 1989, she then worked as a PBC (Primary Breast Care) Nurse and then as a Macmillan ABC (Advanced Breast Cancer) Nurse. It was in this role that Linda developed a particular interest in the treatment and support of older women with Primary Breast Cancer. Her role included giving support and ‘timely’ information to both patient and family from the time of diagnosis, through their decision making process and treatment pathway.

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Speakers’ profiles (cont.) Lynda Wyld

Lynda Wyld is a Senior Lecturer in Surgical Oncology at the University of Sheffield. She has a longstanding interest in the treatment of breast cancer in older women and has written numerous papers on the subject with a particular focus on the use of primary endocrine therapy. She is currently leading the Bridging the Age Gap in Breast Cancer trial, which is a UK multicenter trial trying to establish evidence-based guidelines for surgery or primary endocrine therapy in the frail elderly.

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Supplement  Lecture abstracts L1. Differing biology and clinical relevance Kwok-Leung Cheung

Data exists to suggest that there are biological differences due to age, which may impact on clinical management of primary breast cancer. Our group has demonstrated this in these areas: 1 Subtypes: We identified six biological clusters in older patients, five of which were common in the younger patients, whereas the low ER luminal cluster was distinct in the older series. 2 ER positive: • The older population has a greater preponderance of highly ER positive tumours, when c­ ompared with their younger counterparts. • The 20-year follow-up results of two randomised trials comparing surgery versus primary endocrine therapy in older women with primary breast cancer show that the degree of ER positivity matters in differentiating the effectiveness of these treatment strategies. • In a retrospective cohort, there was no difference in breast cancer specific survival between surgery and primary endocrine therapy if patients had tumours with H-score ≥250. 3 HER2 positive: When compared with their younger counterparts, breast cancers in older patients showed lower Ki67 and higher bcl2 expression. Only 26% of the younger patients and none of the older patients in the series received adjuvant chemotherapy, and no patients at the time received trastuzumab. However, there was no difference in breast cancer specific survival in both groups. 4 Triple negative: Similarly, breast cancers in older patients showed lower rates of Ki67 and CK 7/8 positivity and higher rates of bcl2 and CK18 positivity. There was no difference in the long-term clinical outcome between the two age groups, despite the fact that 47% of the younger patients had adjuvant chemotherapy, while none in the older cohort received such treatment. 5 Histological type: For all patients with ductal type carcinomas, the older series showed better 10-year metastasis-free survival and breast cancer specific survival when compared to the younger series. L2. Decision of systemic treatment for use in an adjuvant setting Etienne Brain

Decision for adjuvant systemic treatment in elderly breast cancer patients stands at a crossroads of different important issues that need to be addressed: goals and expectations which shift throughout the course of lifetime from mere quantity of life to more quality of life, cancer specific prognosis, competing risks for mortality exerted by multimorbidities, epidemiological transition in our modern and ageing world, search for collective cost-benefit and equity, etc. Matching the distribution of molecular phenotypes according to age which favours luminal cases in elderly, prescription of endocrine treatment offers little problem. However this is on the proviso that compliance is correctly monitored to ensure regular drug intake. Oncologists should not hesitate switching of therapeutic group (aromatase inhibitor or anti-oestrogen) when facing side effects which jeopardize compliance and such important domains in elderly as functionality. Chemotherapy and targeted treatments are more aggressive treatments and deserve a more careful assessment before being delivered: they may throw an already fragile health status into a further imbalance, causing it to further complications. All published data from large trials or registries have repeatedly demonstrated the central role of estrogen receptors (ER) in driving mid- and long-term survival benefits from chemotherapy, confining these mostly to ER- cases in the hope of better classifiers. Debarring elderly from access to anti-HER2 treatment on unfair or subjective criteria is common. However, adjuvant trastuzumab therapy discontinuation occurs in up to 40% of 65 years old and older women, highly dependent on age and cardiovascular factors, clues not unveiled to such extent in pivotal trials. Standard algorithms as Adjuvant!Online have been demonstrated to be error-prone methods of poor value for the elderly breast cancer population. There is a crucial need to develop better tools in order to assess individual risk and potential benefit brought by adjuvant treatments in elderly, making the best of new molecular and gene prognosis classifiers reconciled with geriatric assessment.

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L3. The influence of frailty, co-morbidity and dementia on surgical treatments for breast cancer Lynda Wild

As age increases, so does frailty, comorbidity and dementia which impact on the ability of the patient to tolerate standard breast cancer therapies. Breast cancer surgery is well tolerated with a low mortality rate (2/1000) and may be performed under local or regional anesthesia. As 90% of older women will have estrogen receptor positive disease, there is also the option of primary endocrine therapy (PET) for those women who would have an unacceptably high risk of complications from general anesthesia. However, there are no criteria to guide decision making about what levels of frailty, comorbidity or dementia predict that PET will be the optimal treatment. The Bridging the Age Gap Multicentre Trial is collecting data on breast cancer treatment in older women along with baseline data on frailty, comorbidity and dementia and medium and long term outcomes. The study will develop and validate a decision algorithm to aid in the choice between surgery and PET that is responsive to patient fitness. The study is currently recruiting at 43 centers in the UK and data on the first half of the study cohort have been Age, dementia, frailty (measured by the activities of daily living ADL score) and comorbidity all have significant impacts on rates of surgery. For example 89% of women with no documented frailty versus 34% of women scoring in any domain of the ADL received surgery (p < 0.01) and for those with mild or moderate dementia only 33% received surgery versus 75% of women without dementia (p < 0.05). Women with severe dementia who participated in the study via a proxy consent form had even lower rates of surgery. Long term outcome data will provide a valuable insight into whether these treatment strategies and selection criteria provide long term cancer control and optimize quality of life. Disclaimer This work presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG-1209–10071). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

L4. Intra-operative radiotherapy – the TARGIT trial data Jeffrey Tobias

With a high and probably increasing incidence, breast cancer in the older patient remains a major problem both in terms of diagnosis and treatment. Older patients face particular health challenges including a greater likelihood of co-morbidity, a greater reluctance to attend a specialist center if situated at some distance from their homes, and perhaps a reduced tolerance for certain types of treatment. One of the particular hazards facing the elderly patient is the prospect of exhausting multiple journeys for treatment, probably best exemplified by the demands of conventional post-operative radiotherapy following wide local excision, the preferred surgical option for most patients. This requires several weeks of treatment on a daily basis, always fatiguing and often exhausting. However, even the older woman is likely to choose this breast-conserving procedure rather than mastectomy. The emergence of intra-operative radiotherapy for breast cancer has offered an ideal way forward for selected older patients in this trying situation. Treatment essentially consists of a single application of radiotherapy, given at the time of surgery, into the wound cavity immediately after resection of the primary tumor and under the same general anesthetic. The procedure adds about 40 min of extra time to the surgical operation, making this a realistic option for many patients and generally compatible with the organizing and implementation of surgical list planning. Owing to the equipment, there is no need for special sophisticated or expensive radiation shielding in the operating theatre. The treatment unit delivers a high and satisfactory dose of radiation to the cavity exposed at operation, after the carcinoma has been removed. The approach is based on the unequivocal observation that recurrences of breast cancer after wide local excision and whole-breast radiotherapy, which of course occur from time to time, are almost always situated within the “index quadrant”. This and other observations together with the development of the Intrabeam equipment allowed us at UCL Hospitals and 30 collaborating international centers to undertake a large randomized study (3451 patients enrolled between 2000 and 2010) to compare this new approach with the conventional 3–5-week whole-breast external beam radiotherapy program, which has been in use in all parts of the world as standard treatment for over 30 years. The results indicate that patients undergoing ‘single-shot’ intra-operative radiotherapy have a similar low recurrence rate and an overall survival which is not impaired. Side-effects are fewer and cosmetic outcomes improved. There is a high level of patient satisfaction. The outline of this large study, together with results and comments, will be presented.

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Supplement  L5. Age is just a number: why it is important to consider the older women’s experience and their psychosocial needs? Perlita Harris

In this presentation we will discuss the findings and recommendations from the recent All Party Parliamentary Group on Breast Cancer (APPGBC) inquiry on older women and breast cancer, which was conducted in 2013. This looked at how to tackle inequality in the treatment, services and support available to older people with breast cancer in England (it was limited to England as health is a devolved matter). The APPG brought together MPs and Peers with an interest in breast cancer issues as well as representatives from health policymakers, healthcare professionals, and representatives from Breakthrough Breast Cancer, Breast Cancer Campaign and Breast Cancer Care who gave evidence to the inquiry. Our presentation will also highlight some of the work that Breast Cancer Care has done around older women, and discuss how the charity aims to be accessible in its service delivery for older women with breast cancer. L6. Patient-related factors associated with treatment and outcome E Bastiaannet, VC Hamelinck, AM Stiggelbout

Both observational studies and data from clinical trials have shown that breast cancer-specific mortality of older patients is higher than for younger patients, although disease-specific mortality as a proportion of all-cause mortality decreases with age. Moreover, the survival of older breast cancer patients had not improved in the last years. Adherence to surgical and adjuvant systemic treatment guidelines is lower for older patients. Several patient-related factors are associated with this non-adherence and will be discussed, like socioeconomic differences, specific comorbidities, limited life expectancy, poor functional status and patient preferences. Studies have shown that omission of surgery increased in the last years and was at the patient’s request in approximately one-third of the patients; multi-morbidity was mentioned in another 30%. With respect to patient outcome, in 45% of the non-surgically treated patients, breast cancer was not clinically relevant at the time of death. Results of a systematic review with respect to patient preferences showed that for all breast cancer patients, factors related to body image were most frequently related to preference for breast conserving surgery, while factors associated with recurrence and survival were most often related to preferences for mastectomy. In our prospective “Focus On Choice” study, older (versus younger) patients would less often accept adjuvant chemotherapy and endocrine treatment. However, the proportion of older women that would accept therapy was large, and their minimally required benefit did not differ from that of younger women (chemotherapy median: 5 vs 4%, endocrine treatment median: 10 vs 8%). Living without a partner and having an active decisional role were independently related to requiring larger benefits. The most frequently reported motivations were a wish to survive or avoid recurrence and the clinician’s recommendation; and motivations against therapy were side effects and the long treatment duration. Older patients frequently reported additional motivations against chemotherapy (e.g., maintaining quality of life and independence) [1–6] . References 1

Bastiaannet E, Liefers GJ, de Craen AJM et al. Breast cancer in elderly compared to younger patients in The Netherlands: stage at diagnosis, treatment and survival in 127,805 unselected patients. BCRT (2010).

2

Hamelinck VC, Bastiaannet E, Pieterse AH et al. Patients’ preferences for surgical and adjuvant systemic treatment in early breast cancer: a systematic review. CTR (2014).

3

Hamaker ME, Bastiaannet E, Evers D et al. Omission of surgery in elderly patients with early stage breast cancer. EJC (2013).

4

van de Water W, Bastiaannet E, Dekkers OM et al. Adherence to treatment guidelines and survival in patients with early-stage breast cancer by age at diagnosis. BJS (2012).

5

van de Water W, Markopoulos C, van de Velde CJH et al. Association between age at diagnosis and disease-specific mortality among postmenopausal women with receptor–positive breast cancer. JAMA 307(6), 590–597 (2012).

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Hamelinck VC, Bastiaannet E, Pieterse AH et al. A prospective comparison of younger and older patients’ preferences for adjuvant chemotherapy and hormonal therapy in early breast cancer [Unpublished data].

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L7. Older breast cancer patients – the role of the geriatrician S Rostoft

Background: Many patients with primary breast cancer are older, and they may present with comorbidities, functional dependency, and cognitive dysfunction. Several studies have shown that a geriatric assessment identifies remediable problems in older cancer patients, and there are indications that a geriatric assessment may identify patients at risk for treatment toxicities and aid decision making. Discussion: Geriatricians are used to working in multidisciplinary teams that assess older patients and make individual treatment plans. The role of the geriatrician in the oncology setting is not well established, and varies from country to country. A geriatrician could be a valuable contribution to the treatment team in the pre-treatment stage (patient assessment for fitness, including functional status, cognitive function and decision making capacity, comorbidity, polypharmacy, nutritional status, and emotional status) as well as during and after treatment (re-assessment, follow-up) [1,2] . The lecture will include a description of the components of a geriatric assessment and examples from its use in clinical practice. References 1

Hurria A. Geriatric assessment in oncology practice. J. Am. Geriatr. Soc. (Suppl. 2), S246–S249 (2009).

2

Hamaker et al. The effect of geriatric evaluation on treatment decisions for older cancer patients – a systematic review. Acta Oncol. 53(3), 289–296 (2014).

L8. Specific trial methodology and endpoints Etienne Brain

Access of elderly patients to clinical research in oncology has been unfair for the past four decades. This unbalance has spared no strategy from standard development of new chemotherapy agents to recent modern targeted agents as well as biomarkers and ‘omics’ research. Selecting the right endpoints in clinical trials according to age has emerged as a major subject of debate. Goals and life objectives may vary through the life cycle, being more focused in elderly on a “quantity of life of quality” rather than on a single amount of time. In parallel, competing risks of death increase, mostly related to the increase of multimorbidities incidence and severity, while a very high level of heterogeneity of the ageing process further complicates the accurate assessment of physiological age. Of note, many items derived from the geriatric assessment have been proven adequate as primary endpoints to match better the expectations of the elderly population. Unlike younger patients, in whom improvement in relapse-free and overall survival may be the major goal, older patients indeed often prioritize living independently and preservation of cognitive dysfunctions, being likely to forego a small improvement in survival that comes with a loss of function. Confrontation of cancer treatment to short-term or longterm life expectancy assessed through survival algorithms is also an important field of research, depending on adjuvant or metastatic and palliative settings, and may challenge the current new prognostic and predictive classifiers. In social sciences and humanities, barriers in willingness to participate to clinical trials are under investigation but seem more often physician-based than patient-based. In spite of many so-called geriatric intervention studies, the genuine demonstration of the prognostic impact of geriatric assessment on cancer outcome in the elderly population remains an unavoidable step to improve the level of conviction of the community of oncologists that geriatric assessment and collaboration with geriatricians are of key importance for this growing population.

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Supplement  Poster abstracts P1. Additional assessments of older women with primary operable breast cancer – a pilot study RM Parks1, L Hall1, S-W Tang1, P Howard2, R Lakshamanan1, L Winterbottom3, DAL Morgan4, A Hurria5, K Cox2 & KL Cheung1 School of Medicine, University of Nottingham, UK School of Health Sciences, University of Nottingham, UK 3 Nottingham Breast Institute, Nottingham University Hospitals, UK 4 Department of Oncology, Nottingham University Hospitals, UK 5 City of Hope, Duarte, CA, USA 1 2

Background: In routine clinical practice, older women with primary operable breast cancer tend to be assessed by traditional clinical assessment, focusing predominantly on the tumor biology, prior to treatment decision making. This is a pilot study conducted as part of ongoing research program aiming to evaluate the value of additional assessments. Methods: Women aged ≥70 years with newly diagnosed stage I/II breast cancer were invited to participate in the study. Actual treatment planning was made by the clinical team and was not part of the study. Comprehensive Geriatric Assessment (CGA), quality of life (QOL) assessment using EORTC QLQC30 and QLQ-BR23 and semi-structured interviews were conducted at diagnosis. Results: A total of 47 patients participated in the study at point of analysis (29 received operative treatment, with the remaining patients treated non-operatively). On CGA, patients of increasing age (p = 0.001), greater comorbidity (p = 0.022), taking more daily medications (p = 0.002) and with slower ‘Timed Up and Go’ scores (p = 0.014) were associated with non-operative treatment. When assessing QOL, patients who had non-surgery were more likely to have a better social functioning score (p = 0.032) and better body image (p = 0.001), however they suffered from increased pain (p = 0.048) and greater financial difficulties (p = 0.001). Semi-structured interviews showed that this cohort of patients were generally happy with their decision made and future outlook. Discussion: Factors identified in this study may be of potential value in guiding treatment selections. The study is ongoing and is now being extended in multiple centers. P2. Breast cancer in the older population: frailty assessment tools AT Halka1, P Marshall1, C Bill1, C Priestley1, J O’Sullivan1, N Scott1, M Tomlinson1 & L Whisker1 Nottingham Breast Institute, Nottingham City Hospital, Nottingham University Hospitals NHS trust, Hucknall Road, Nottingham, NG5 1PB, UK

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Background: The APPG “Age is just a number” report (2013) recommended developing a tool to measure patients’ fitness for treatment to help inform decisions and ensure effective management. We investigate the practical use of a triple assessment tool in use within the trust to identify frailty in elderly patients. Methods: Over an 8 week period consecutive patients, aged 65 and older, with a new presentation of breast cancer were identified at the MDT. The degree of frailty was assessed by an HCA in clinic using 3 tools, clinical assessments, the identification of seniors at risk score (ISAR) and WHO performance score. Doctors giving results were blinded to the assessment and continued standard management. Data from each patient’s frailty assessment was then collated with the following data: ●● Therapeutic treatment received (primary endocrine therapy [PET] versus surgery) ●● Delays in treatment target ●● Extended stay in hospital

Results: Sixty patients were included in our audit with an average age of 74 years (range: 65–92). Clinical assessment correlated with the ISAR score and WHO performance status. Thirteen patients were clinically judged as frail; ten had an ISAR score greater than or equal to two. Nine had a WHO performance status of two and above. 9/13 received PET. Forty-seven patients were clinically deemed not to be frail, all had an ISAR score 0–1 and WHO performance status 0–1. 7/47 patients received PET. Six patients did not undergo surgery within 31 days; five patients through choice and one had an acute event after assessment in clinic. Three patients experienced a delayed discharge (all pre-operatively assessed as not being frail). Discussion: This fast, simple tool identified patients who are frail. However, the triple assessment added very limited information to the standard clinical assessment. The Age-gap study continues and will hopefully aid development of a more effective tool.

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P3. An analysis of the decision-making preferences of older women with operable breast cancer in the UK Jenna Morgan1, Karen Collins2, Thompson Robinson3, Kwok-Leung Cheung4, Riccardo Audisio5, Malcolm Reed1 & Lynda Wyld1; on behalf of the Bridging the Age Gap Trial Management Team Academic Unit of Surgical Oncology, University of Sheffield Medical School, Beech Hill Road, Sheffield, UK Centre for Health and Social Care Research, Sheffield Hallam University, Collegiate Crescent, Sheffield, UK 3 Department of Cardiovascular Sciences, Leicester Royal Infirmary, Infirmary Square, Leicester, LE2 7LX, UK 4 School of Medicine, University of Nottingham, Royal Derby Hospital Centre, Uttoxeter Road, Derby, DE22 3DT, UK 5 Department of Surgery, University of Liverpool, St Helens Teaching Hospital, Marshalls Cross Road, St Helens, WA9 3DA, UK 1 2

Introduction: The use of primary endocrine therapy (PET) as an alternative to surgery for older women with operable breast cancer is common in the UK. Current guidelines state that only patient choice and those who are unfit for surgery should be treated this way. Previous studies have suggested that lower rates of surgery in the elderly are unlikely due to patient choice. Methods: This was a prospective observational cohort study of women aged over 70 years diagnosed with operable primary breast cancer in 43 breast cancer units across the UK. Data were collected on patient and tumor characteristics, treatment type, as well as the patients’ preferred and actual decision-making (DM) styles for their breast cancer treatment using a validated questionnaire instrument. Results: Of the 653 patients analyzed, 530 (81.2%) underwent surgery and 123 (18.8%) were treated with PET. Patients preferred a doctor-centered DM style in 220 (33.7%), a shared DM style in 253 (38.7%) and a patient-centered DM style in 180 (27.6%). Patients rated their actual DM style as doctor-centered in 244 (37.4%), shared in 203 (31.1%) and patient-centered in 206 (31.5%). Agreement between preferred and actual DM style was 73.4% (Kappa = 0.60, p < 0.01). Both preferred and actual DM styles were associated with final treatment type (p < 0.01). Patients treated with PET had more patient-centered treatment decisions (43.9%) compared to shared (24.4%) or doctor-centered (31.7%). Whereas patients who underwent surgery were more likely to have a doctor-centered (38.7%) or shared (32.6%) treatment decision as opposed to patient-centered (28.7%). Conclusion: Patients had a moderate likelihood of achieving their preferred DM-style. These results suggest that some of the use of PET in the elderly breast cancer population may be due to patient choice. Disclaimer This abstract presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG-1209–10071). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

P4. The effect of dementia on the treatment of older women with breast cancer in England Jenna Morgan1, Paul Richards2, Sue Ward2, Gill Lawrence3, Matthew Francis3, Karen Collins4, Malcolm Reed1 & Lynda Wyld1 Academic Unit of Surgical Oncology, University of Sheffield Medical School, Beech Hill Road, Sheffield, UK Department of Health Economics and Decision Science, School for Health and Related Research, University of Sheffield, Sheffield, UK 3 Public Health England, Knowledge and Information Team (West Midlands), 5 St Philip’s Place, Birmingham, UK 4 Centre for Health and Social Care Research, Sheffield Hallam University, Collegiate Crescent, Sheffield, UK 1 2

Introduction: Primary endocrine therapy (PET) a common alternative to surgery for the treatment of older patients with operable estrogen-receptor positive breast cancer in the UK, in particular for those patients who are deemed unfit for operative management. Significant cognitive impairment affects up to 10% of women over 65. There is little in the literature on how women with dementia and breast cancer are treated in the UK and there are no guidelines regarding the most appropriate treatment method for this group of patients. Methods: Data from two cancer registry regions were obtained for women over 70 years diagnosed with operable breast cancer between 2002 and 2010 on patient and tumor characteristics as well as treatment type. Matched HES data were obtained to identify patients with Dementia. Results: Of the 17,129 patients for who data were available, 245 (1.4%) were identified as having dementia. Patients with dementia were more likely to be treated with PET (214/245; 87.3%) compared to patients without dementia (6960/16884; 41.2%; p < 0.05). Accounting for age and treatment type, overall survival was significantly worse in the dementia cohort (p < 0.05). There was no significant difference seen for breast cancer-specific survival after accounting for age and treatment type due to small numbers, although the data do suggest that patients with dementia may also have worse breast cancer-specific survival. Conclusion: Older patients with dementia are less likely to undergo surgery for their breast cancer and have worse overall survival. Further work is needed to examine whether dementia has any effect on breast cancer-specific survival. Disclaimer This abstract presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG-1209–10071). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

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Supplement  P5. Case mix does not fully explain variation in rates of non-surgical treatment of older women with operable breast cancer Jenna Morgan1, Paul Richards2, Sue Ward2, Matthew Francis3, Gill Lawrence3, Karen Collins4, Malcolm Reed1 & Lynda Wyld1 Academic Unit of Surgical Oncology, University of Sheffield Medical School, Beech Hill Road, Sheffield, UK Department of Health Economics and Decision Science, School for Health and Related Research, University of Sheffield, Sheffield, UK 3 Public Health England, Knowledge and Information Team (West Midlands), 5 St Philip’s Place, Birmingham, UK 4 Centre for Health and Social Care Research, Sheffield Hallam University, Collegiate Crescent, Sheffield, UK 1 2

Introduction: Non-surgical management of older women with ER+, operable breast cancer is common in the UK with varying rates (10–40%) of over 70s receiving primary endocrine therapy (PET). Whilst this may be appropriate for frailer patients, for some it may result in treatment failure, contributing to the poor outcomes seen in this age group. Case mix may explain some of the treatment variation. Methods: Data from two UK regional cancer registries were analyzed to identify whether variation in treatment observed between 2002 and 2010 at hospital and clinician level persisted following adjustment for case mix. Expected case-mix adjusted surgery rates were derived by logistic regression using the variables age, proxy Charlson Co-morbidity Score, deprivation quintile, method of cancer detection, tumor size, stage, grade and nodal status. Results: Data on 17154 women over 70 with ER+ operable breast cancer were analyzed using control charts. 95% and 99% control limits were defined on the assumption that the rate per unit was normally distributed, with mean and standard error based on the observed proportion of patients receiving surgery in the cohort. There was considerable variation in rates of surgery at both hospital and clinician level, with 39/68 (57.4%) of hospitals and 73/167 (43.7%) of clinicians falling outside the 95% limits. High variation remained after adjustment for case mix at the hospital level (30/68; 44.1% remaining outside of the 95% limits), but was substantially reduced at the clinician level (17/167; 10% remaining outside of the 95% limits). Conclusion: Varying selection criteria for older women for operative treatment of early breast cancer may mean that some older women are being under or over treated, which may partly explain the inferior disease outcomes associated with this age group. It emphasises the urgent need for evidence-based guidelines for treatment selection criteria in older women with breast cancer. Disclaimer This abstract presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG-1209–10071). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

Ethical disclosure For studies involving data relating to human or animal experimental investigations, appropriate institutional review board approval has been obtained and is described within the article (for those investigators who do not have formal ethics review committees, the principles outlined in the Declaration of Helsinki have been followed). For investigations involving human subjects, informed consent has been obtained from the participants involved and an explanation of how this was obtained is included in the manuscript.

P6. Comparative analysis of breast cancer in the elderly Yih Chyn Phan1, Tina Xu1, Vicky Stevenson1 & Chinedu Chianakwalam1 Breast Unit, William Harvey Hospital, Kent, UK

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Background: The management of breast cancer in the elderly population is currently under debate [1–6] . In particular there is concern that elderly patients receive suboptimal treatment [1–6]. The aim of the study is to evaluate the characteristics, management and outcome of breast cancer in two demographic groups of patients aged 50–69 years and 70 years and above at diagnosis in a district general hospital. Methods: The database was searched for two groups of patients with breast cancer aged 50–69 years and 70 years and over respectively at diagnosis over an 8 year period from May 2005 to April 2013. Their characteristics and management were reviewed, and their breast cancer specific survival (BCSS) and overall survival (OS) were calculated using the Kaplan-Meier method. Results: Please refer to Table 1 and Figures 1–3 (see page 16). Patients aged 50–69 years: There were 579 patients with a mean age of 60 years. Tumor Type: Ductal 86%; Lobular 14%. Tumor Grade: G1 18%, G2 47%, G3 33%, NR 2%. Median tumor size 2.0cm. ER+ 83%; ER- 17%. HER2+ 12%; HER2- 73%; NR 15%. 11% patients had no surgery. 23% had mastectomies and 66% breast conserving surgery (BCS). 35% had axillary node sample, 36% sentinel node biopsy and 17% axillary node clearance. The axillary status was unknown in 11% patients. 81% received radiotherapy, 38% chemotherapy and 80% had endocrine therapy. The 5 year BCSS was 89% and OS 86%. Patients aged 70 years and over: There were 397 patients with a mean age of 79 years. Tumor Type: Ductal 86%; Lobular 14%. Tumor grade: G1 15%, G2 52%, G3 32%, NR 1%. Median tumor size 2.1cm. ER+ 85%; ER- 15%. HER2+ 12%; HER2- 66%; NR 22%. 40% patients had no surgery. 29% had mastectomies and 31% breast conserving surgery (BCS). 18% had axillary node sample, 20% sentinel node biopsy and 15% axillary node clearance. The axillary status was unknown in 46% patients. 42% received radiotherapy,

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5% chemotherapy and 83% had endocrine therapy. The 5 year BCSS was 76% and OS 56%. Discussion & conclusion: A significant number of patients aged 70 years and above with breast cancer did not have surgery or chemotherapy compared to the younger age group. There was a significant difference in both the breast cancer specific and overall survival in favor of the younger group. These findings are similar to other studies [1–5,7] .. w. Table 1. Results of the data analysis are shown in the table and survival curves below. Age group (years) Patients (n) Mean age (years) Types of tumor: – Infiltrating ductal (%) – Infiltrating lobular (%) Grade of tumor: – G1 (%) – G2 (%) – G3 (%) – NR (%) Mean tumor size (cm) ER status: – ER positive (%) – ER negative (%) HER2 status: – HER2 positive (%) – HER2 negative (%) – NR (%) No surgery (%) Surgery: – Mastectomy (%) – Breast conserving surgery (%) Axillary node sampling (%) Sentinel node biopsy (%) Axillary node clearance (%) Node status unknown (%) Chemotherapy (%) Radiotherapy (%) Endocrine therapy (%) 5-year breast cancer-specific survival (%) 5-year overall survival (%)

50–69 579 60

70 and above 397 79

85 15

86 14

18 47 33 2 2.0

15 52 32 1 2.1

83 17

85 15

12 73 15 11

12 66 22 40

23 66 35 36 17 11 38 81 80 89 86

29 31 18 20 15 46 5 42 83 76 56

References 1

Smith BD, Jiang J, McLaughlin SS et al. Improvement in breast cancer outcomes over time: are older women missing out? J. Clin. Oncol. 29, 4647–4653 (2011).

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Joerger M, Thürlimann B, Savidan A et al. Treatment of breast cancer in the elderly: a prospective, population-based Swiss study. J. Geriatr. Oncol. 4(1), 39–47 (2013).

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Sarkar A, Shahi U. Assessment of cancer care in Indian elderly cancer patients: a single center study. S. Asian J. Cancer 2(4), 202–208 (2013).

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O’Connor T, Shinde A, Doan C et al. Managing breast cancer in the older patient. Clin. Adv. Hematol. Oncol. 11(6), 341–347 (2013).

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Syed BM, Parks RM, Cheung KL. Management of operable primary breast cancer in older women. Women’s Health 10(4), 405–422 (2014).

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van de Water W, Bastiaannet E, Egan KM et al. Management of primary metastatic breast cancer in elderly patients – an international comparison of oncogeriatric versus standard care. J. Geriatr. Oncol. 5(3), 252–259 (2014).

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Petrakis IE, Paraskakis S. Breast cancer in the elderly. Arch. Gerontol. Geriatr. 50(2), 179–184 (2010).

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Supplement  P7. Clinical outcome of primary endocrine therapy for Chinese patients aged 70 years or older with operable breast cancer KK Ma1, DTK Suen1, & Ava Kwong*,1 1 Division of Breast Surgery, Department of Surgery, The University of Hong Kong Li Ka Shing Faculty of Medicine, Hong Kong SAR *Author for correspondence: [email protected]

Background: This study aims to evaluate the clinical outcome of primary endocrine therapy for elderly Chinese patients with operable breast cancer. Methods: We performed a retrospective review of elderly patients (age ≥70 years) with operable breast cancer who received primary endocrine therapy in a university hospital from January 2000 to December 2009. Results: During the study period, 39 Chinese patients (median age at diagnosis: 85 years; interquartile range [IQR]: 77–99 years) having operable breast cancer received primary endocrine therapy with a mean follow-up of 58 months. Nineteen patients (49%) had an initial response (median time to response [TTR]: 5 months; IQR: 4–17), while 17 patients (44%) showed stable disease. A total of 21 patients (54%), with or without prior response, eventually displayed progression (median time to progression [TTP]: 19 months; IQR: 11–52). Eight patients (21%) required salvage or palliative therapy. No significant difference in TTR and TTP was observed between the patients starting with tamoxifen and those starting with an aromatase inhibitor. Median overall survival for early stage (stage 0–2) was 58 months (IQR: 35–66) and for late stage (stage 3) was 72 months (IQR: 37–91; p = 0.351). Twenty-six patients (67%) died within the censor period. Ten of them (39%) died of breast cancer. Discussion: Primary endocrine therapy was a reasonable option for elderly patient with operable breast cancer. Majority of patient can achieve stable disease, partial response or even complete clinical response. They have fairly good overall survival and majority of them are died of cause other than breast cancer. Ethical disclosure For investigations involving human subjects, informed consent has been obtained from the participants involved and an explanation of how this was obtained is included in the manuscript.

P8. Primary breast cancer in older Chinese women as compared to their younger counterparts DTK Suen1, KK Ma1 & A Kwong*,1 Division of Breast Surgery, Department of Surgery, The University of Hong Kong Li Ka Shing Faculty of Medicine, Hong Kong SAR *Author for correspondence: [email protected] 1

Background: This study aims to investigate the treatment, tumor biology and survival of breast cancer in elderly Chinese patients. A comparison was made with their younger counterparts. Methods: A retrospective study of patients with breast cancer who have undergone surgery in a university hospital from January 2001 to December 2009 was performed. Treatment options, tumor characteristics and survival of patients aged 70 and above were compared with those aged below 70. Results: 2826 Chinese patients with breast cancer underwent surgery during the study period. 394 patients (14%) were aged 70 and above, and 2432 patients (86%) were aged below 70. More elderly patients had mastectomy than breast conservation (p < 0.0005). Less elderly patients received chemotherapy and radiotherapy (p < 0.0005). The use of hormonal therapy was similar between the two groups. Breast cancer in older women were of better histological grading (P < 0.0005), more estrogen receptor positive (p = 0.03) and less HER-2 oncogene overexpression (p = 0.016). The overall median survival for elderly patients was 5.27 years, which is worse than their younger counterparts (6.48 years; p < 0.0005), whereas the breast cancer specific survival were comparable between these two age groups. Discussion: Older Chinese women with breast cancer received less aggressive treatment. Despite this, the breast cancer specific survival in this older age group women was similar to that of their younger counterparts. This may be attributed to the better tumor prognostic indexes. The overall survival in elderly patients was worse, which may be explained by the presence of other non-cancer related causes of death. Ethical disclosure For investigations involving human subjects, informed consent has been obtained from the participants involved and an explanation of how this was obtained is included in the manuscript.

P9. Biological explanation of the histological grade – older versus younger women with early operable primary breast cancer BM Syed1, AR Green1, DAL Morgan1, IO Ellis1 & KL Cheung1 School of Medicine, University of Nottingham, and *Department of Oncology, Nottingham University Hospitals, Nottingham, UK

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Introduction: Histological grade is one of the basic prognostic factors in breast cancer, where Grade III shows poor prognosis as compared to grade I and II. This study aimed to analyse biological pattern of the histological grades in older women (≥70 years) and compare it with that in the younger (60 years of age) but there is scant evidence of its effectiveness. We reviewed our local experience. Methods: We reviewed our prospectively complied departmental database from January 2011–October 2014 to identify patients who had received NET. Patient demographics were recorded. Ultrasound was used to document initial cancer size and to monitor size during treatment. The primary outcome measure was the comparison of initial radiological size to final histological size. Results: In this period 16 patients treated with NET progressed to surgery. All had ER +ve breast cancer. 6 (38%) were lobular cancers. 13 patients were treated with anastrazole and 3 with letrozole. The mean length of treatment was 8 months (range: 3–24 months). Median age was 67 years (range: 57–77 years). The mean initial tumor size on USS was 21 mm (range: 11–30 mm). Post-operative histological analysis demonstrated a mean size of 19.8 mm (range: 10–34 mm). Less than 2 mm change in size (recorded as ‘no change’) was seen in five cases treated for a mean of 6 months. Four cancers appeared larger post-operatively than on initial imaging (up to 9 mm increase in size). Interestingly, these all appeared stable or reducing in size on follow up USS. 8 cancers (50%) decreased in size. The mean size reduction was 28% (range: 16–53%). Discussion: Half of the cancers shrank and another one-third remained stable in size on NET. No obvious difference was seen between ductal and lobular cancers. This information is useful to share with women considering this treatment route. Reference 1

Cheung KL, Ellis IO, Morgan DAL et al. Optimising the management of primary breast cancer in older women – a report of a multi-disciplinary study day. Breast 20, 581–584 (2011).

P18. Outcomes in breast cancer patients treated with primary endocrine therapy assessed in a elderly multidisciplinary clinic J Isherwood1, H Hawrot1, V Chavda1, B Vijaynagra1, S Orgill1, T Robinson1, A Stotter1 & M Kaushik1 Glenfield Hospital, Leicester, UK

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Introduction: Treatment and management of elderly patients with breast cancer is increasingly challenging. This patient cohort often present with multiple co-morbidities limiting surgical intervention. There is a lack of robust evidence and guidelines for the treatment of patients >70 years old [1] . We present the long-term follow-up results of patients treated with primary endocrine therapy (PET) in this group. Methods: This is a retrospective analysis of a prospectively maintained database. Data was collected at a joint elderly breast clinic involving a breast surgeon, geriatrician, anesthetist and a breast care nurse. Patients were assessed and screened for markers of frailty and perceived risk of adverse outcomes using various standardised tools. Results: 211 patients who received PET out of a total of 582 patients were reviewed over a 13-year period. Median age of patients at diagnosis was 84 years old. Tumour histology included 147 ductal, 23 lobular and 14 mixed cancersand a variety of other pathological types. Receptor status included 184 estrogen positive, 84 progesterone positive and 59 HER positive. Patients had a median MMSE score of 20/30, Barthel index score of 18/20 and Charleston Comorbidity Index score of 2. Patients had a median of 5 clinic visits. Patients were treated with PET including: tamoxifen (n = 116), anastrozole (n = 115), exemestane (n = 28) and letrozole (n = 31). Median survival from initial presentation was 14.6 months. Conclusion: Treatment of elderly patients with breast cancer proves a challenge. This analysis demonstrates that primary endocrine therapy is anacceptable management option in this complex group of patients demonstrating high comorbidity index in the assessment tools used. This is a complex group of patients and well-designed studies are required to provide an evidence base to develop comprehensive and standardised oncogeriatrictreatment protocols. Reference 1

Albrand G, Terret C. Early breast cancer in the elderly: assessment and management considerations. Drugs Aging 25, 35–45 (2008).

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Abstracts of the Third Symposium on Primary Breast Cancer in Older Women, March 6, 2015, Nottingham, England.

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