Title: Bridging the age gap in breast cancer. Improving outcomes for older women.
Funder: Department of Health and Social Care

Abstract: Title: Bridging the age gap in breast cancer. Improving outcomes for older women. Aims: Aim 1: To optimise the surgical treatment of older women with breast cancer. Workstreams 1 & 2. To provide an evidence-based, management algorithm to ensure older women (>70 years) with early breast cancer are offered optimal treatment with surgery & ensure that primary endocrine therapy (PET) is offered appropriately only to women who are sufficiently frail to derive little benefit from surgery. For these women we will develop a Decision Support Instrument (DSI) to facilitate informed choice. Aim 2: To optimise breast screening provision for older women. Workstream 3 & 4. To determine the optimal upper age limit at which continued mammographic screening is clinically and economically effective and to support older women in making an informed choice about ongoing screening and promoting early symptomatic presentation by the development of an information support tool Background: Research plan. Breast cancer affects some 13 000 UK women >70 & causes the deaths of 6733 each year. Younger women with breast cancer have seen a 44% improvement in survival in the past 30 years compared to only a 19% improvement in the >70s. This relates to a combination of under-treatment & a lack of routine screening in this age group. Of concern is the widespread use of primary endocrine therapy (PET) where surgery is omitted & anti-oestrogens are used as the only treatment. Whilst this is effective in frailer older women, UK practice is highly varied, with a 4 fold variation in the rate of non-surgical treatment. Inevitably this means some women will be under treated, others over treated. This study will develop a clinical management algorithm to ensure that clinicians have easy access to the risk & benefit ratios of the choice of each treatment (surgery or PET) for each woman permitting tailored counselling. Older women themselves will be provided with decision support by the development of a DSI facilitating shared decision making. The second issue is that screening is not routinely offered to women >70. In the younger age group (50-70) screening is responsible for a 25-40% increase in breast cancer survival. Older women may self refer for screening but uptake rates are poor due to lack of screening awareness & a perception that screening unnecessary. The risk to benefit ratio of screening is less favourable with increasing age & at some point screening ceases to be beneficial. This study will develop an evidence base to inform decisions about the optimal age cut off for breast screening. In view of concerns about the lack of balanced information about the risks & benefits of screening it will also develop a tailored information support tool to facilitate screening decisions. Both projects will be based on direct data collection from cancer registries & from 22 UK Breast Units who will submit data for 2 comprehensive cohort studies. The potential for bias in cohort studies will be addressed by correction for patient health & disease state variance. These data will be used to develop 2 models to predict long term outcomes, health economic costs & Quality of Life (QoL) in screened versus non screened & surgically treated versus PET treated women. Using qualitative methods we will develop our DSI based on initial data collection from older women about their information needs & preferences. The DSI will be rigorously field tested before being made available to UK breast Units. Similarly, we will develop our screening information tool using mixed methods & then pilot & test the tool using well validated methods. Research team. The team comprises nationally & internationally recognised experts in the fields of elderly breast cancer care, health services modelling, elderly care, screening, decision support, cancer registry expertise, health services research & PPI. Research environment. The research will be led by the University of Sheffield with support from across the UK including the Universities of Nottingham, Hallam, Cardiff, Leicester & Liverpool & 20 UK Breast Units. Trial management will be by the CTRU at SCHARR in Sheffield. Anticipated outputs: The results of the programme will be made available nationally & internationally through high impact journal publication, learned society presentation & will be accessible via the web & to user groups. Patient & public involvement (PPI). PPI is central to this programme. We have done extensive pilot work with patients to establish their views about screening & PET & have a team of patient representatives & Breakthrough Breast Cancer involved. Ethical implication. The prog. will require Multi-Centre Ethics & R & D approval. The project is ethically non controversial with similar projects gaining approval recently (ESTEEM & screening age extension). Justification for resources. The project represents excellent value for the anticipated benefits to an underserved patient group.

Lay abstract: Breast cancer affects 13000 UK women >70 annually & the incidence will rise with growth in the elderly population. Patients >70 have seen less than half of the reduction in cancer mortality compared to younger women. This is due to lack of breast screening resulting in later stage at diagnosis & sub-optimal treatment due to concerns about ill health reducing treatment tolerance. However fitness in older women is variable & many tolerate standard therapies & continue to benefit from screening. There is little research evidence to guide best practice in these patients. Screening & therapy studies are inadequate & outdated as population health & longevity have risen. National, evidence based guidance is needed to optimise treatment & care for older women. However any initiatives must involve informed patient choice. Therefore, this programme includes the following workstreams to provide data to guide best practice & aid older women make informed choices about their care. Workstreams: 1).Optimisation of Surgery. Ideally, surgery should be offered to all women with breast cancer who will tolerate it. The less fit may be offered primary endocrine therapy (PET) as an alternative to surgery. However rates of non-surgical treatment vary 4 fold between regions suggesting a need for guidelines. Modelling, based on retrospective & prospective UK data will be used to develop an accessible web-based clinical management algorithm. 2).Treatment Decision Support. Little is known about the information needs of older women with cancer. The programme will develop & evaluate a series of decision support instruments, tailored to older women, to support them in deciding between surgery or PET for those women where both options are likely to give good outcomes. 3).Optimisation of Screening. Women >70 are not routinely invited for breast screening because of a lack of research supporting benefit in this age group. Most older women would prefer ongoing screening (1). Modelling, based on retrospective & prospective UK data, will be used to determine the optimal upper age limit for screening. 4).Screening Information Support. The risk to benefit ratio of screening in older women may be less favourable than for younger women & therefore, older women should be aware of potential harms. This programme will support older women in making an informed choice about ongoing screening & promote early symptomatic presentation by the development of an information support tool.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: CANCER AND NEOPLASMS