Identifying research priorities for improving information and support for patients undergoing breast cancer surgery: a UK patient-centred priority setting project.

PURPOSE: To use robust consensus methods with individuals with lived breast cancer experience to agree the top 10 research priorities to improve information and support for patients undergoing breast cancer surgery in the UK. METHODS: Research uncertainties related to information and support for breast cancer surgery submitted by patients and carers were analysed thematically to generate summary questions for inclusion in an online Delphi survey. Individuals with lived breast cancer experience completed two Delphi rounds including feedback in which they selected their top 10 research priorities from the list provided. The most highly ranked priorities from the survey were discussed at an in-person prioritisation workshop at which the final top 10 was agreed. RESULTS: The 543 uncertainties submitted by 156 patients/carers were categorised into 63 summary questions for inclusion in the Delphi survey. Of the 237 individuals completing Round 1, 190 (80.2%) participated in Round 2. The top 25 survey questions were carried forward for discussion at the in-person prioritisation workshop at which 17 participants from across the UK agreed the final top 10 research priorities. Key themes included ensuring patients were fully informed about all treatment options and given balanced, tailored information to support informed decision-making and empower their recovery. Equity of access to treatments including contralateral mastectomy for symmetry was also considered a research priority. CONCLUSION: This process has identified the top 10 research priorities to improve information and support for patients undergoing breast cancer surgery. Work is now needed to develop studies to address these important questions.

Understanding Patient Experiences to Inform Future Studies to Optimize Personalization of Treatment for Early Breast Cancer.

BACKGROUND: Breast cancer treatment is multimodal, but not all patients benefit from each treatment, and many experience morbidities significantly impacting quality of life. There is increasing interest in tailoring breast cancer treatments to optimize oncological outcomes and reduce treatment burden, but it is vital that future trials focus on treatments that most impact patients. This study was designed to explore patient experiences of treatment to inform future research. METHODS: An online survey was co-developed with patient advocates to explore respondents' experiences of breast cancer treatment. Questions included simple demographics, treatments received, and views regarding omitting treatments if that is deemed safe. The survey was circulated via social media and patient advocacy groups. Responses were summarized by using simple statistics; free text was analyzed thematically. RESULTS: Of the 235 participants completing the survey, 194 (82.6%) would choose to omit a specific treatment if safe to do so. The most commonly selected treatments were chemotherapy (n = 69, 35.6%) and endocrine therapy (n = 61, 31.4%) mainly due to side effects. Fewer respondents would choose to omit surgery (n = 40, 20.6%) or radiotherapy (n = 20, 10.3%). Several women commented that survival was their "absolute priority" and that high-quality evidence to support the safety of reducing treatment would be essential. CONCLUSIONS: Patients with breast cancer are individuals who may wish to optimize different components of their treatment. A portfolio of studies co-designed with patients is needed to establish an evidence base for greater treatment personalization with studies focused on reducing avoidable chemotherapy and endocrine therapy a priority.

Outcomes of Women Undergoing Mastectomy for Unilateral Breast Cancer Who Elect to Undergo Contralateral Mastectomy for Symmetry: A Systematic Review.

BACKGROUND: Breast reconstruction (BR) is routinely offered to restore symmetry after mastectomy for breast cancer. Not all women, however, may want reconstructive surgery. A contralateral mastectomy (CM) to achieve "flat symmetry" can be an excellent alternative, but surgeons are often reluctant to offer this procedure. This systematic review aimed to summarize the available evidence regarding the outcomes of CM as the first step to developing guidelines in this area. METHODS: PubMed, MEDLINE, CINAHL and PsycINFO were searched to identify primary research studies, published in English between 1 January 2000 and 30 August 2022, evaluating clinical or patient-reported outcomes for women who underwent a CM without reconstruction after a mastectomy for unilateral breast cancer. Simple descriptive statistics summarized quantitative data, and content analysis was used for qualitative data. RESULTS: The study included 15 studies (13 quantitative, 1 qualitative, and 1 mixed-methods) evaluating outcomes for at least 1954 women who underwent a bilateral mastectomy without reconstruction (BM) after unilateral breast cancer. The risk of surgical complications after BM was higher than after unilateral mastectomy without reconstruction (UM) but significantly less than after BR. Satisfaction with the decision for BM was high in all the studies. Key themes relating to flat denial, stigma, and gender-based assumptions were identified. CONCLUSION: Women electing to undergo BM reported high levels of satisfaction with their decision and complication rates similar to those for UM. Further study is needed to comprehensively explore the outcomes for women seeking BM, but these data should give surgeons confidence to offer the procedure as an alternative option for symmetry after unilateral mastectomy for breast cancer. REGISTRATION: This systematic review was prospectively registered on the PROSPERO database (CRD42022353689).

Understanding decision-making for and against oncoplastic breast-conserving surgery as an alternative to a mastectomy in early breast cancer: UK ANTHEM qualitative study.

BACKGROUND: Oncoplastic breast-conserving surgery may allow women with early breast cancer to avoid a mastectomy, but many women undergo more extensive surgery, even when breast-conserving options are offered. The aim of the ANTHEM qualitative study was to explore factors influencing women's surgical decision-making for and against oncoplastic breast-conserving surgery. METHODS: Semi-structured interviews were conducted with a purposive sample of women who had received either oncoplastic breast-conserving surgery or a mastectomy with or without immediate breast reconstruction to explore their rationale for procedure choice. Interviews were transcribed verbatim and analysed thematically. Trial registration number: ISRCTN18238549. RESULTS: A total of 27 women from 12 centres were interviewed. Out of these, 12 had chosen oncoplastic breast-conserving surgery and 15 had chosen a mastectomy with or without immediate breast reconstruction. Overwhelmingly, women's decisions were guided by their surgical teams. Decision-making for and against oncoplastic breast-conserving surgery was influenced by three key inter-related factors: perceptions of oncological safety; the importance of maintaining/restoring femininity and body image; and practical issues. Oncological safety was paramount. Women who reported feeling reassured that oncoplastic breast-conserving surgery was oncologically safe were happy to choose this option. Those who were not reassured were more likely to opt for a mastectomy, as a perceived 'safer' option. Most women wished to maintain/restore femininity, with the offer of immediate breast reconstruction essential to make a mastectomy an acceptable option. Practical issues such as the perceived magnitude of the surgery were a lesser concern. CONCLUSION: Decision-making is complex and heavily influenced by the surgical team. High-quality, accurate information about surgical options, including appropriate reassurance about the short- and long-term oncological safety of oncoplastic breast-conserving surgery is vital if women are to make fully informed decisions.

Overall survival after mastectomy versus breast-conserving surgery with adjuvant radiotherapy for early-stage breast cancer: meta-analysis.

BACKGROUND: Breast-conserving surgery with adjuvant radiotherapy and mastectomy are currently offered as equivalent surgical options for early-stage breast cancer based on RCTs from the 1970s and 1980s. However, the treatment of breast cancer has evolved and recent observational studies suggest a survival advantage for breast-conserving surgery with adjuvant radiotherapy. A systematic review and meta-analysis was undertaken to summarize the contemporary evidence regarding survival after breast-conserving surgery with adjuvant radiotherapy versus mastectomy for women with early-stage breast cancer. METHODS: A systematic search of MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), and Embase that identified studies published between 1 January 2000 and 18 December 2023 comparing overall survival after breast-conserving surgery with adjuvant radiotherapy versus mastectomy for patients with unilateral stage 1-3 breast cancer was undertaken. The main exclusion criteria were studies evaluating neoadjuvant chemotherapy, rare breast cancer subtypes, and specific breast cancer populations. The ROBINS-I tool was used to assess risk of bias, with the overall certainty of evidence assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool. Studies without critical risk of bias were included in a quantitative meta-analysis. RESULTS: From 11 750 abstracts, 108 eligible articles were identified, with one article including two studies; 29 studies were excluded from the meta-analysis due to an overall critical risk of bias, 42 studies were excluded due to overlapping study populations, and three studies were excluded due to reporting incompatible results. A total of 35 observational studies reported survival outcomes for 909 077 patients (362 390 patients undergoing mastectomy and 546 687 patients undergoing breast-conserving surgery with adjuvant radiotherapy). The pooled HR was 0.72 (95% c.i. 0.68 to 0.75, P < 0.001), demonstrating improved overall survival for patients undergoing breast-conserving surgery with adjuvant radiotherapy. The overall certainty of the evidence was very low. CONCLUSION: This meta-analysis provides evidence suggesting a survival advantage for women undergoing breast-conserving surgery with adjuvant radiotherapy for early-stage breast cancer compared with mastectomy. Although these results should be interpreted with caution, they should be shared with patients to support informed surgical decision-making.

Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocol.

INTRODUCTION: The introduction of novel surgical techniques and procedures remains poorly regulated and standardised. Although the learning curve associated with invasive procedures is a critical part of innovation, it is currently inconsistently defined, measured and reported. This study aims to develop a core data set that can be applied in all studies describing or measuring the learning curve in novel invasive procedures. METHODS: A core data set will be developed using methods adapted from the Core Outcome Measures in Effectiveness Trials initiative. The study will involve three phases: (1) Identification of a comprehensive list of data items through (a) an umbrella review of existing systematic reviews on the learning curve in surgery and (b) qualitative interviews with key stakeholders. (2) Key stakeholders (eg, clinical innovators, clinicians, patients, methodologists, statisticians, journal editors and governance representatives) will complete a Delphi survey to score the importance of each data item, generating a shortened list. (3) Consensus meeting(s) with stakeholders to discuss and agree on the final core data set. ETHICS AND DISSEMINATION: The study is approved by an Institutional Ethics Committee at the University of Bristol (ref: 111362). Participants will complete written informed consent to participate. Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, patient engagement events, use of social media platforms, workshops and other events.

The association of breast surgery ASPIRE: breast pain pathway rapid evaluation project - study protocol.

Background: Breast pain accounts for 20-40% of new referrals to breast units in the UK and these patients have a very low risk of breast cancer. Patients have previously been assessed in resource-intensive, cancer-exclusion, one stop clinics, which are now failing to meet government targets due to excessive demand. UK Breast units are increasingly piloting Breast Pain-only Pathways (BPP) to assess these patients, and there is no consensus for the optimal pathway. The aim of this prospective multicentre study is to assess the safety and patient satisfaction of different BPPs to inform future BPP design and implementation. Methods: All UK breast units will be invited to join the ASPIRE study between January 2023 and December 2023. Units with a BPP are invited to submit their pathway for evaluation; and those without a BPP who see patients with breast pain-only in a one stop clinics setting are also invited to join the study to evaluate the traditional pathway model concurrently. Patient satisfaction assessments will be collected after their initial consultation and patient outcomes, including subsequent cancer diagnosis, will be followed up at 12 months to determine if they have cancer diagnosis after discharge to assess pathway safety.

The MARECA (national study of management of breast cancer locoregional recurrence and oncological outcomes) study: protocol for a prospective, multicentre cohort study.

Background: Despite a UK 5-year breast cancer survival rate of 86.6%, patients may develop breast cancer recurrence within the same breast after breast conserving surgery, as well as in the remaining skin or chest wall after mastectomy or in the ipsilateral lymph glands. These recurrences, collectively termed locoregional recurrence (LRR), occur in around 8% of patients within 10 years of their original diagnosis. Currently, there is a lack of robust information on the presentation and prevalence of LRR with no UK-specific clinical guidelines available for the optimal management of this patient group. Additionally, there is a need to identify patterns of LRR presentation and their progression, which will enable prognostic factors to be determined. This will subsequently enable the tailoring of treatment and improve patient outcome. Methods: The MARECA study is a prospective, multicentre cohort study recruiting patients diagnosed with breast cancer LRR +/- associated distant metastases. Over 50 UK breast units are participating in the study with the aim of recruiting at least 500 patients over a recruitment period of 24 months. The data collected will detail the tumour pathology, imaging results, surgical treatment, radiotherapy and systemic therapy of the primary and recurrent breast cancer. Study follow-up will be for up to 5 years following LRR diagnosis to determine subsequent oncological outcomes and evaluate potential prognostic factors. Discussion: This study will address the current knowledge gap and identify subgroups of patients who have less successful treatment outcomes. The results will determine the current management of LRR and the prognosis of patients diagnosed with breast cancer LRR +/- distant metastases in the UK, with the aim of establishing best practice and informing future national guidelines. The results will direct future research and inform the design of additional interventional trials and translational studies.

Protocol for the development of a core outcome set and reporting guidelines for locoregional treatment in neoadjuvant systemic breast cancer treatment trials: the PRECEDENT project.

INTRODUCTION: Neoadjuvant systemic anticancer therapy (neoSACT) is increasingly used in the treatment of early breast cancer. Response to therapy is prognostic and allows locoregional and adjuvant systemic treatments to be tailored to minimise morbidity and optimise oncological outcomes and quality of life. Accurate information about locoregional treatments following neoSACT is vital to allow the translation of downstaging benefits into practice and facilitate meaningful interpretation of oncological outcomes, particularly locoregional recurrence. Reporting of locoregional treatments in neoSACT studies, however, is currently poor. The development of a core outcome set (COS) and reporting guidelines is one strategy by which this may be improved. METHODS AND ANALYSIS: A COS for reporting locoregional treatment (surgery and radiotherapy) in neoSACT trials will be developed in accordance with Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development guidelines. Reporting guidance will be developed concurrently.The project will have three phases: (1) generation of a long list of relevant outcome domains and reporting items from a systematic review of published neoSACT studies and interviews with key stakeholders. Identified items and domains will be categorised and formatted into Delphi consensus questionnaire items. (2) At least two rounds of an international online Delphi survey in which at least 250 key stakeholders (surgeons/oncologists/radiologists/pathologists/trialists/methodologists) will score the importance of reporting each outcome. (3) A consensus meeting with key stakeholders to discuss and agree the final COS and reporting guidance. ETHICS AND DISSEMINATION: Ethical approval for the consensus process will be obtained from the Queen's University Belfast Faculty Ethics Committee. The COS/reporting guidelines will be presented at international meetings and published in peer-reviewed journals. Dissemination materials will be produced in collaboration with our steering group and patient advocates so the results can be shared widely. REGISTRATION: The study has been prospectively registered on the COMET website (https://www.comet-initiative.org/Studies/Details/2854).

Exploring locoregional treatment reporting in neoadjuvant systemic breast cancer treatment studies: A systematic review.

Accurate information about locoregional treatments in breast cancer neoadjuvant systemic therapy (NST) trials is vital to support surgical decision-making and allow meaningful interpretation of long-term oncological outcomes. This systematic review (PROSPERO registration CRD42023470891) aimed to describe the current practice of outcome reporting in NST studies. A systematic search identified primary research studies published 01/01/2018-08/09/2023 reporting outcomes in patients receiving NST for breast cancer followed by locoregional treatment. Included were randomised controlled trials (RCTs) and non-randomised studies (NRS) with >250 participants reporting at least one locoregional treatment outcome. Outcomes were extracted verbatim and categorised using content analysis. Descriptive statistics were used to summarise results. Of the 3111 abstracts screened, 137 studies (22 RCTs and 115 NRS) reporting at least one locoregional outcome in 575,531 patients were included. The 137 studies reported a total of 510 surgical outcomes with a median of 3 (range 1-12) per study. No single outcome was reported in all studies. Type of breast (n = 129, 94.2 %) and axillary (n = 86, 62.8 %) surgery were reported most frequently. Only 34 % (n = 47) studies reported how treatment response was assessed and if/how this informed surgical decision-making. Only a fifth (n = 28) reported outcomes relating to surgical de-escalation. Only 72 studies (52.6 %) reported any radiation therapy (RT)-related outcome, most frequently whether RT had been received (n = 63/72, 87.5 %). Current reporting of locoregional treatment outcomes in NST studies is poor, inconsistent and urgently needs to be improved. A core outcome set and reporting guidelines may improve the quality and value of future research.