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Introduction: Women considering immediate breast reconstruction (IBR) after mastectomy for breast cancer require high-quality information about the short and long-term outcomes of different procedure types to allow them to make informed decisions about their surgical options. Long-term multicentre patient-reported outcomes (PROs) comparing the patients’ perspectives of different techniques is currently lacking. The UK Brighter study aimed to compare the long-term patient-reported outcomes of different types of IBR to support informed decision-making. Methods: Women who underwent unilateral mastectomy and/or breast reconstruction for invasive breast cancer or ductal carcinoma in situ (DCIS) in England between 1 April 2008 and 31 March 2009 were identified from National Health Service (NHS) Hospital Episode Statistics (HES), and current contact information for the surviving cohort were provided by the NHS Personal Demographic Service. Women were sent a letter inviting them to complete three validated patient report questionnaires, the BREAST Q, EQ-5D5L and ICECAP-A, electronically or by post at a minimum of 12 years following their index surgery. Questionnaires were scored according to developers’ instructions and results compared by type of IBR procedure performed. Results: 11,977 women were invited to participate of whom 4,207 (35.1%) completed the questionnaires. Of these, 1,236 (29.4%) received IBR with 343 (27.8%) expander/implant (EI) reconstructions, 629 (50.9%) latissimus dorsi (LD) procedures with or without an implant, and 264 (21.4%) abdominal flap (AF) reconstructions. The mean age at index surgery was 52.1 years, standard deviation (SD) 9.5. The majority of respondents were white (n=1,179, 97.4%) and predominantly from areas of the lowest socioeconomic deprivation. The mean body mass index (BMI) was 24.6 (SD 3.9). 141 (11.6%) women actively smoked at the time of surgery and 227 (19.0%) had a complication requiring further surgery. Women undergoing AFs reported significantly higher ‘Satisfaction with Breasts’ (mean 67.7, SD 20.4) than those undergoing LD (mean 58.9, SD 21.1), or EI reconstructions (mean 54.7, SD 19.2), (p< 0.001). ‘Satisfaction with Breasts’ was also greater in women undergoing index surgery over 50 years of age (p=0.02) and in those who did not smoke (p=0.03) whereas experiencing post-operative complications was strongly associated with poorer ‘Satisfaction with Breasts’ in the multivariable analysis (p=0.001). Women receiving AF also reported better ‘Physical Well-being’ (mean 87.8, SD 16.04) than women undergoing LD flap (mean 79.5, SD 20.5) or EI procedures (mean 82.1, SD 18.2), (p< 0.001). Overall, women undergoing AFs were more likely to rate the outcome of their surgery as ‘excellent’ or ‘very good’ (189/256, 73.8%) compared with those receiving other reconstruction types (LD - 386/610, 63.3%; EI - 175/331, 52.9%, p< 0.001). Conclusion: Women undergoing abdominal flap reconstruction report significantly better outcomes 12 years following IBR than women receiving other reconstruction types. These findings should be shared with women considering breast reconstruction to help them make informed decisions about their surgical options. Citation Format: Leigh Johnson, Paul White, Ranjeet Jeevan, John Browne, Carmel Gulliver-Clarke, Joe O’Donoghue, Syed Mohiuddin, William Hollingworth, Patricia Fairbrother, Mairead MacKenzie, Chris Holcombe, Shelley Potter. PD15-09 Impact of procedure type on the long-term patient-reported outcomes of immediate breast reconstruction: The UK Brighter Study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD15-09.

Introduction: Post-mastectomy radiotherapy (PMRT) is an important component of breast cancer treatment and has been shown to improve overall survival for women with large cancers or node positive disease. The long-term effects of radiotherapy on the outcomes of immediate breast reconstruction (IBR) and how these are perceived from the patients’ perspective, however, are largely unknown. The UK Brighter study aimed to evaluate the long-term impact of PMRT on the patient-reported outcomes of IBR to support informed decision-making. Methods: Women who underwent unilateral mastectomy and/or breast reconstruction for invasive breast cancer or ductal carcinoma in situ (DCIS) in England between 1/4/2008 and 31/3/2009 were identified from National Health Service (NHS) Hospital Episode Statistics (HES), and current contact information for the surviving cohort provided by the NHS Personal Demographic Service. Women were sent a letter inviting them to complete three validated patient-reported outcome questionnaires, the BREAST Q, EQ-5D-5L and ICECAP-A, electronically or by post at a minimum of 12 years following their index surgery. Questionnaires were scored according to developers’ instructions and scores for women who had received PMRT following IBR compared with those who underwent IBR without radiotherapy, in the cohort as a whole and by reconstruction type. Results: 11,977 women were invited to participate of whom 4,207 (35.1%) completed the questionnaires. Some 1,236 (29.4%) underwent IBR with 343 (27.8%) expander/implant (EI) reconstructions, 629 (50.9%) latissimus dorsi (LD) flaps with or without (+/-) an implant, and 264 (21.4%) abdominal flap (AF) reconstructions. Of these, 388 (31.4%) (EI n=79 (20.4%); LD+/-implant n=222 (57.2%); AF n=87 (22.4%) received PMRT. In the cohort overall, women who received PMRT following IBR reported significantly lower ‘Satisfaction with Breasts’ scores at 12 years compared with those who did not receive radiotherapy (PMRT mean 56.4. standard deviation (SD) 21.5 vs. no PMRT mean 61.3, SD 20.5), p< 0.001). However, this difference varied across procedure types. Specifically, the ‘Satisfaction with Breasts’ scores of women receiving PMRT following AF reconstruction were 10.5 points lower than those not receiving PMRT (PMRT mean 60.9, SD 20.2; no PMRT mean 71.4, SD 19.6, p< 0.001). This difference was lower in in women undergoing LD reconstruction (mean with PMRT 54.3, SD 21.1; mean without PMRT 61.6, SD 20.7; p< 0.001). There were no significant differences in women undergoing EI reconstruction (PMRT mean 57.5, SD 23.6, no PMRT mean 53.9, SD 17.7). ‘Physical Well-being’ (chest) scores were also significantly lower in women receiving PMRT following IBR in the cohort overall (PMRT mean 78.7, SD 20.1, no PMRT 83.6, SD 18.6, p< 0.001) but women undergoing AF reconstruction showed the greatest difference in scores (PMRT mean 83.2, SD 17.0 vs No PMRT mean 90.1, SD 15.0, p< 0.001). There were no significant differences in ‘Physical Well-being’ scores for women who underwent EI reconstruction with or without PMRT. ‘Psychosocial Well-being’ scores were lower in women receiving PMRT after IBR (PMRT mean 70.8, SD 22.0, No PMRT 75.4, SD 21.0), but again, differential effects were seen by procedure type with no significant differences seen in the EI group but significant differences in scores seen in women receiving PMRT after flap-based procedures. Conclusions: Women undergoing PMRT report significantly lower long-term patient-reported outcomes of flap-based reconstruction, in particular ‘Satisfaction with Breasts’ and ‘Physical Well-being’ scores. This difference was not apparent in women undergoing EI procedures. This information should be shared with patients to help them make fully informed decisions about the type and timing of their reconstructive surgery. Citation Format: Leigh Johnson, Paul White, Ranjeet Jeevan, John Browne, Carmel Gulliver-Clarke, Joe O’Donoghue, Syed Mohiuddin, William Hollingworth, Patricia Fairbrother, Mairead MacKenzie, Chris Holcombe, Shelley Potter. Impact of radiotherapy on the long-term patient-reported outcomes of immediate breast reconstruction: The UK Brighter [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-15-03.

Background: Mammographic screening programmes reduce breast cancer mortality, but detect many small tumours with favourable biological features which may not progress during a woman’s lifetime. Screen-detected cancers are treated with standard surgery and adjuvant therapies, with associated morbidities. There is a need to reduce overtreatment of good prognosis tumours and numerous studies have evaluated the omission of radiotherapy in this context. However, there is little evidence to support surgical de-escalation, although percutaneous minimally invasive treatment approaches have been described. Vacuum-assisted excision (VAE) is in widespread use for management of benign lesions and lesions of uncertain malignant potential. SMALL (ISRCTN 12240119) is designed to determine the feasibility of using this approach for treatment of small invasive tumours detected within the UK NHS Breast Screening Programme (BSP). Methods: SMALL is a phase III multicentre randomised trial comparing standard surgery with VAE for screen-detected good prognosis cancers. The main eligibility criteria are age ≥47 years, unifocal grade 1 tumours with maximum diameter 15mm, which are strongly ER/PR+ve and HER2-ve, with negative clinical/radiological axillary staging. Patients are randomised 2:1 in favour of VAE or surgery; with no axillary surgery in the VAE arm. Completeness of excision is assessed radiologically, and if excision is incomplete, patients undergo open surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm but may be omitted following surgery. Co-primary end-points are: 1. Non-inferiority comparison of the requirement for a second procedure following excision 2. Single arm analysis of local recurrence (LR) at 5 years following VAE Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure. This ensures sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. To ensure that the trial as a whole only has 5% alpha, the significance level for each co-primary outcome is set at 2.5% with 90% power. The Data Monitoring Committee will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A novel feature of SMALL is the integration of a QuinteT Recruitment Intervention (QRI), which aims to optimise recruitment to the study. Recruitment challenges are identified by analysing recruiter/patient interviews and audio-recordings of trial discussions, and by review of trial screening logs, eligibility and recruitment data and study documentation. Solutions to address these are developed collaboratively, including individual/group recruiter feedback and recruitment tips documents. Results: SMALL opened in December 2019, but recruitment halted in 2020 for 5 months due to COVID-19. At 7st July 2022, 142 patients had been randomised from 26 centres, with a randomisation rate of approximately 45%, and a per site recruitment rate of 0.4-0.5 patients/month, approaching the feasibility recruitment target of 144 patients. Drawing from preliminary QRI findings and insights from patient representatives, a recruitment tips document has been circulated (on providing balanced information about treatments, encouraging recruiters to engage with patient preferences, and explaining randomisation). Individual recruiter feedback has commenced, with wider feedback delivered across sites via recruitment training workshops. Conclusion: Despite pandemic-related challenges, SMALL has an excellent recruitment rate to date and is expected to have a global impact on treatment of breast cancer within mammographic screening programmes. SMALL is funded by the UK NIHR HTA programme, award 17/42/32 Citation Format: Stuart A. McIntosh, Charlotte E. Coles, David Dodwell, Kenneth Elder, Jessica Foster, Claire Gaunt, Amanda Kirkham, Iain Lyburn, Jenna Morgan, Sangeetha Paramasivan, Sarah E. Pinder, Sarah Pirrie, Shelley Potter, Tracy Roberts, Nisha Sharma, Hilary Stobart, Elizabeth Southgate, Sian Taylor-Phillips, Matthew Wallis, Daniel Rea. SMALL: Open Surgery versus Minimally invasive vacuum-Assisted excision for smaLL screen-detected breast cancer – a UK phase III randomised multi-centre trial [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-20-02.

Objective: To develop a core outcome set (COS), an agreed minimum set of outcomes to measure and report in all studies evaluating the introduction and evaluation of novel surgical techniques.Summary Background Data: Agreement on the key outcomes to measure and report for safe and efficient surgical innovation is lacking, hindering transparency and risking patient harm.Methods: (I) Generation of a list of outcome domains from published innovation-specific literature, policy/regulatory body documents, and surgeon interviews; (II) Prioritization of identified outcome domains using an international, multi-stakeholder Delphi survey; (III) Consensus meeting to agree the final COS. Participants were international stakeholders, including patients/public, surgeons, device manufacturers, regulators, trialists, methodologists and journal editors.Results: 7,972 verbatim outcomes were identified, categorized into 32 domains, and formatted into survey items/questions. 410 international participants (220 professionals, 190 patients/public) completed at least one round 1 survey item, of which 153 (69.5%) professionals and 116 (61.1%) patients completed at least one round 2 item. 12 outcomes were scored ‘consensus in’ (‘very important’ by ≥70% of patients and professionals) and 20 ‘no consensus’. A consensus meeting, involving 19 professionals and 10 patient/public representatives, led to agreement on a final 8-domain COS. Six domains are specific to a surgical innovation context: modifications, unexpected disadvantages, device problems, technical procedure success, whether the overall desired effect was achieved, surgeons’/operators’ experience. Two domains relate to intended benefits and expected disadvantages.Conclusions: The COS is recommended for use in all studies prior to definitive RCT evaluation to promote safe, transparent, and efficient surgical innovation.

Background Innovative surgical procedures and devices are often modified throughout their development and introduction into clinical practice. A systematic approach to reporting modifications may support shared learning and foster safe and transparent innovation. Definitions of ‘modifications’, and how they are conceptualized and classified so they can be reported and shared effectively, however, are lacking. This study aimed to explore and summarize existing definitions, perceptions, classifications and views on modification reporting to develop a conceptual framework for understanding and reporting modifications. Methods A scoping review was conducted in accordance with PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines. Targeted searches and two database searches were performed to identify relevant opinion pieces and review articles. Included were articles relating to modifications to surgical procedures/devices. Data regarding definitions, perceptions and classifications of modifications, and views on modification reporting were extracted verbatim. Thematic analysis was undertaken to identify themes, which informed development of the conceptual framework. Results Forty-nine articles were included. Eight articles included systems for classifying modifications, but no articles reported an explicit definition of modifications. Some 13 themes relating to perception of modifications were identified. The derived conceptual framework comprises three overarching components: baseline data about modifications, details about modifications and impact/consequences of modifications. Conclusion A conceptual framework for understanding and reporting modifications that occur during surgical innovation has been developed. This is a first necessary step to support consistent and transparent reporting of modifications, to facilitate shared learning and incremental innovation of surgical procedures/devices. Testing and operationalization is now needed to realize the value of this framework.

Background:. Mammographic screening programmes have been shown to reduce breast cancer mortality. However, they detect many small tumours with favourable biological features which may not progress during a woman’s lifetime. These are treated with standard surgery and adjuvant therapies, which have associated morbidities. Thus, there is a need to reduce overtreatment of good prognosis tumours found by screening. Minimally invasive treatment approaches have been described but there is no prospective randomised evidence to support their routine use. Vacuum-assisted excision (VAE) is in widespread use for management of benign lesions and lesions of uncertain malignant potential. SMALL (ISRCTN 12240119) is designed to determine the feasibility of using this approach for treatment of small invasive tumours detected within the UK NHS Breast Screening Programme (BSP). Methods:. SMALL is a phase III multicentre randomised trial comparing standard surgery with VAE for screen-detected good prognosis breast cancers. The main eligibility criteria are age ≥47 years, screen-detected unifocal grade 1 tumours with maximum diameter 15mm, which are strongly ER/PR+ve and HER2-ve, with negative clinical/radiological axillary staging. Patients are randomised 2:1 in favour of VAE or surgery; with no axillary surgery in the VAE arm. Completeness of excision is assessed radiologically, and if excision is incomplete, patients undergo open surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm but may be omitted following surgery. Co-primary end-points are:1.Non-inferiority comparison of the requirement for a second procedure following excision2.Single arm analysis of local recurrence (LR) at 5 years following VAE. Recruitment of 800 patients over 4 years will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure. This ensures sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. To ensure that the trial as a whole only has 5% alpha, the significance level for each co-primary outcome is set at 2.5% with 90% power. The Data Monitoring Committee will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A QuinteT Recruitment Intervention (QRI) is integrated throughout SMALL to optimise recruitment and informed consent. Recruitment challenges are identified by analysing recruiter/patient interviews and audio-recordings of trial discussions, and by review of screening, eligibility and recruitment data and study documentation. Solutions to address these are developed collaboratively, including individual/group recruiter feedback and recruitment tips documents. Results:. SMALL opened in December 2019, but recruitment halted in 2020 due to suspension of the NHS BSP for 5 months due to COVID-19. As of 1st July 2021, 55 patients had been approached in 10 centres, with 33 patients randomised (randomisation rate 60%). A further 23 centres are in set-up, with 8 suspended due to the pandemic. Drawing from preliminary QRI findings and insights from patient representatives, a recruitment tips document has been circulated (on introducing and discussing SMALL, providing balanced information. on treatment options and explaining randomisation). individual recruiter feedback has commenced, with wider feedback planned shortly. Conclusion:. Despite pandemic-related challenges, SMALL has an excellent recruitment rate to date and is expected to have a global impact on treatment of breast cancer within mammographic screening programmes. SMALL is funded by the UK NIHR HTA programme, award 17/42/32 Citation Format: Stuart A McIntosh, Charlotte E Coles, Carmel Conefrey, David Dodwell, Kenneth Elder, Jessica Foster, Claire Gaunt, Amanda Kirkham, Iain Lyburn, Jenna Morgan, Sangeetha Paramasivan, Sarah Pinder, Sarah Pirrie, Shelley Potter, Tracy Roberts, Nisha Sharma, Hilary Stobart, Elizabeth Southgate, Sian Taylor-Phillips, Matthew Wallis, Daniel Rea. SMALL - Open surgery versus minimally invasive vacuum-assisted excision for small screen detected breast cancer: A phase 3 randomised trial [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT1-06-02.

Background: Breast augmentation is the most commonly performed cosmetic procedure, and increasingly women in this group present with breast cancer or request risk-reducing surgery, but their optimal management is unclear. The authors explored the clinical and patient-reported outcomes of patients undergoing immediate implant-based breast reconstruction following previous augmentation and compared these with outcomes of patients who had not had cosmetic implants in the Implant Breast Reconstruction Evaluation (iBRA) Study.Methods: Patients undergoing immediate implant-based breast reconstruction were prospectively recruited from breast and plastic surgical units across the United Kingdom. Demographic, operative, and oncologic data, and information regarding complications within 3 postoperative months were collected. Patient-reported outcomes at 18 months were assessed using the BREAST-Q. The clinical and patient-reported outcomes of patients undergoing immediate implant-based breast reconstruction with and without previous breast augmentation were compared.Results: A total of 2108 women were included in the iBRA Study, of whom 49 had undergone a previous augmentation. Women in the augmentation group were younger (median age, 45 years versus 50 years; p = 0.01), had a lower body mass index (22.8 kg/m2 versus 24.9 kg/m2; p < 0.01), and had smaller tumors (15 mm versus 25 mm; p = 0.01) than patients without augmentation. No differences were seen in operative technique between the groups. Complications at 3 months were similar in both groups and there were no significant differences in patient-reported outcomes at 18 months.Conclusions: The clinical and patient-reported outcomes of patients undergoing immediate implant-based breast reconstruction following previous augmentation are consistent with those observed in the wider iBRA Study cohort, supporting the safety of this approach.

Simple Summary Most breast cancers are small and can be treated using breast-conserving surgery. Since these tumors are non-palpable, they require a localization step that helps the surgeon to decide which tissue needs to be removed. The oldest localization technique is a guidewire placed into the tumor before surgery, usually using ultrasound or mammography. Afterwards, the surgeon removes the tissue around the wire tip. However, this technique has several disadvantages: It can cause the patient discomfort, requires a radiologist or another professional specialized in breast diagnostics to perform the procedure shortly before surgery, and 15-20% of patients need a second surgery to completely remove the tumor. Therefore, new techniques have been developed but most of them have not yet been examined in large, prospective, multicenter studies. In this review, we discuss all available techniques and present the MELODY study that will investigate their safety, with a focus on patient, surgeon, and radiologist preference. Background: Surgical excision of a non-palpable breast lesion requires a localization step. Among available techniques, wire-guided localization (WGL) is most commonly used. Other techniques (radioactive, magnetic, radar or radiofrequency-based, and intraoperative ultrasound) have been developed in the last two decades with the aim of improving outcomes and logistics. Methods: We performed a systematic review on localization techniques for non-palpable breast cancer. Results: For most techniques, oncological outcomes such as lesion identification and clear margin rate seem either comparable with or better than for WGL, but evidence is limited to small cohort studies for some of the devices. Intraoperative ultrasound is associated with significantly higher negative margin rates in meta-analyses of randomized clinical trials (RCTs). Radioactive techniques were studied in several RCTs and are non-inferior to WGL. Smaller studies show higher patient preference towards wire-free localization, but little is known about surgeons\" and radiologists\" attitudes towards these techniques. Conclusions: Large studies with an additional focus on patient, surgeon, and radiologist preference are necessary. This review aims to present the rationale for the MELODY (NCT05559411) study and to enable standardization of outcome measures for future studies.

Introduction: Innovation in surgery drives improvements to patient care. New surgical procedures and devices typically undergo a series of modifications as they are developed and refined during their introduction into clinical practice. These changes should ideally be reported and shared between surgeon-innovators to promote efficient, safe and transparent innovation. Currently, agreement on how modifications should be defined, conceptualised and classified, so they can be reported and shared efficiently and transparently, is lacking. The aim of this review is to examine and summarise existing literature on definitions, perceptions and classifications of modifications to surgical procedures/devices, including views on how to measure and report them. The findings will inform future work to standardise reporting and sharing of modifications in surgical innovation.Materials and Methods: A systematic scoping review will be conducted adhering to PRISMA-ScR guidelines. Included articles will focus on review articles and opinion pieces relevant to modifications to new surgical procedures or devices introduced to clinical practice. Methods to identify relevant literature will include systematic searches in MEDLINE (Ovid version), targeted internet searches (Google Scholar) and snowball searches. A two-stage screening process (titles/abstracts/keywords and full-texts) will use specified exclusion/inclusion criteria to identify eligible articles. Data on how modifications are i) defined, ii) perceived, and iii) classified, and iv) views on how modifications should be measured and reported, will be extracted verbatim. Inductive thematic analysis will be applied to extracted data where appropriate. Results will be presented as a narrative summary including descriptive characteristics of included articles. Findings will inform a preliminary conceptual framework to facilitate the systematic reporting and sharing of modifications to novel procedures and devices.HighlightsThis work will generate an in-depth understanding of how modifications are currently defined, perceived and classified, and views on how they may be reported, in the context of surgical innovation.Rigorous and comprehensive search methods will be applied to identify a wide range of diverse data sources for inclusion in the review.A summary of existing relevant literature on modifications is a necessary step to inform development of a framework for transparent, real-time reporting and sharing of modifications in future studies of innovative invasive procedures/devices.

Purpose A James Lind Alliance priority setting partnership was developed to identify research priorities in breast cancer surgery from individuals with lived experience, at high genetic risk of breast cancer, and healthcare professionals (HCPs). Methods ‘Uncertainties’ were collected using an online survey. Following an evidence check and development of summary questions, an interim survey asked participants to rank their top 10 research priorities from the question list. Top-ranked questions from patient/carer, high-risk and professional groups were carried forward for discussion to a final online prioritisation workshop. Results 260 participants (101 patients/carers, 156 HCPs) submitted 940 uncertainties via the initial survey. These were analysed thematically into 128 summary questions in six topic areas. Following evidence checking, 59 questions were included in the interim survey which was completed by 572 respondents. Marked differences were seen in questions prioritised by patients/carers, HCPs and women at high-risk. The top eight priorities in patient/carer and professional groups and top two priorities for high-risk women were carried forward to the online workshop at which 22 participants discussed and agreed the final top 10. Key themes included de-escalation of breast and axillary surgery, factors impacting the development/detection of locoregional recurrence and optimal provision of support for informed treatment decision-making. Conclusion The top 10 research priorities in breast cancer surgery have been agreed. However, the observed differences in research priorities identified by patients and professional groups were not anticipated. Top priorities from both groups should inform future UK breast cancer surgical research, to ensure that it addresses questions that are important to breast cancer community as a whole.

Aims Well-designed surgical registries are essential for high-quality patient-centred evaluation of implantable devices and surgical procedures. However, there is currently a lack of information about how existing registries are designed and funded; what data is collected and how this can be used. The aim of this work is to identify existing surgical registries in the UK and describe and summarise their key characteristics to inform recommendations for how surgical registries may be improved. Methods Existing surgical registries were identified using multiple different sources, including: society websites; search engine review; a targeted search of Medline and Embase databases and expert knowledge. Details of each registry were extracted using a standardised data extraction proforma developed by the study team. Characteristics of identified registries were summarised into a narrative review. Results 47 active national surgical registries have been identified, with further identification of registries ongoing. 29 (62%) registries monitor surgical devices and all monitor surgical procedures, with 18 (38%) being mandatory. 40 (87%) registries were accessible online, and 24 (51%) linked with other datasets. 39 (83%) collected clinical outcomes with no core outcome set, and 1 collected clinical outcomes with a core outcome set. 15 (32%) collected patient-reported outcome measures. All registries operated in England with 41 (87%) active in Wales, 28 (60%) in Scotland, and 24 (51%) in Northern Ireland. Length of follow up varied from in hospital to 10 years. Conclusions There is considerable heterogeneity in existing surgical registries. Further work is needed to establish a consensus for surgical registry development.

Multifocal and multicentric breast cancers (MFMCBCs) have traditionally been considered a contraindication to breast-conserving surgery (BCS) because of concerns about locoregional control.The most common definition of MFMCBC is anatomical, based on the presence of cancer foci either in a single breast quadrant (multifocal) or in more than one (multicentric). Other definitions are based on the distance between tumours, with multifocal tumours defined as being within 2 cm of each other (up to 5 cm in some articles), and multicentric tumours further away.The reported incidence of MFMCBC varies between 4 and 60 per cent, and has increased, possibly owing to improved imaging accuracy resulting in better detection rates. Similarly, BCS rates for MFMCBC have increased over time as a result of the introduction of advanced oncoplastic techniques that allow en bloc resection of all cancer foci while preserving (or even improving) breast cosmesis. These advances in oncoplastic breast surgery, together with the support of the St Gallen expert panel and emerging evidence of no significant difference in disease-free or overall survival between MFMCBC and unifocal cancers, have resulted in changing practice, with many surgeons considering BCS in selected patients. This topic is still, however, debated as other authors have questioned the oncological safety of BCS in this setting because of a lack of RCTs or high-quality prospective cohort studies.

Introduction\ud \ud Shared learning is imperative in the assessment and safe implementation of new healthcare interventions. Magnetic seeds (Magseed®) potentially offer logistical benefit over wire localisation for non-palpable breast lesions but few data exist on outcomes comparing these techniques. A national registration study (iBRA-NET) was conducted to collate device outcomes. In order to share learning, thematic analysis was conducted to ascertain early clinical experiences of Magseed® and wire guided localisation and explore how learning events may be applied to improve clinical outcomes.\ud \ud \ud \ud Methods\ud \ud A qualitative study of 27 oncoplastic surgeons, radiologists and physicians was conducted in January 2020 to ascertain the feasibility and challenges associated with Magseed® versus wire breast localisation surgery. Four focus groups were asked to discuss experiences, concerns and shared learning outcomes which were tabulated and analysed thematically.\ud \ud \ud \ud Results\ud \ud Three key themes were identified comparing Magseed® and wire localisation of breast lesions relating to preoperative, intraoperative and postoperative learning outcomes. Percutaneous Magseed® detection, instrument interference and potential seed or wire dislodgement were the most common issues identified. Clinician experience suggested Magseed® index lesion identification was non-inferior to wire placement and improved the patient pathway in terms of scheduling and multi-site insertion.\ud \ud \ud \ud Conclusions\ud \ud Prospective shared learning suggested Magseed® offered additional non-clinical benefits over wire localisation, improving the efficiency of the patient pathway. Recommendations for improving breast localisation technique, appropriate patient selection and clinical practice through shared learning are discussed that may aid other surgeons in the adoption of this relatively new technique.

Background Future innovations in science and technology with an impact on multimodal breast cancer management from a surgical perspective are discussed in this narrative review. The work was undertaken in response to the Commission on the Future of Surgery project initiated by the Royal College of Surgeons of England. Methods Expert opinion was sought around themes of surgical de-escalation, reduction in treatment morbidities, and improving the accuracy of breast-conserving surgery in terms of margin status. There was emphasis on how the primacy of surgical excision in an era of oncoplastic and reconstructive surgery is increasingly being challenged, with more effective systemic therapies that target residual disease burden, and permit response-adapted approaches to both breast and axillary surgery. Results Technologies for intraoperative margin assessment can potentially half re-excision rates after breast-conserving surgery, and sentinel lymph node biopsy will become a therapeutic procedure for many patients with node-positive disease treated either with surgery or chemotherapy as the primary modality. Genomic profiling of tumours can aid in the selection of patients for neoadjuvant and adjuvant therapies as well as prevention strategies. Molecular subtypes are predictive of response to induction therapies and reductive approaches to surgery in the breast or axilla. Conclusion Treatments are increasingly being tailored and based on improved understanding of tumour biology and relevant biomarkers to determine absolute benefit and permit delivery of cost-effective healthcare. Patient involvement is crucial for breast cancer studies to ensure relevance and outcome measures that are objective, meaningful, and patient-centred.

Background The B-MaP-C study aimed to determine alterations to breast cancer (BC) management during the peak transmission period of the UK COVID-19 pandemic and the potential impact of these treatment decisions. Methods This was a national cohort study of patients with early BC undergoing multidisciplinary team (MDT)-guided treatment recommendations during the pandemic, designated ‘standard’ or ‘COVID-altered’, in the preoperative, operative and post-operative setting. Findings Of 3776 patients (from 64 UK units) in the study, 2246 (59%) had ‘COVID-altered’ management. ‘Bridging’ endocrine therapy was used (n = 951) where theatre capacity was reduced. There was increasing access to COVID-19 low-risk theatres during the study period (59%). In line with national guidance, immediate breast reconstruction was avoided (n = 299). Where adjuvant chemotherapy was omitted (n = 81), the median benefit was only 3% (IQR 2–9%) using ‘NHS Predict’. There was the rapid adoption of new evidence-based hypofractionated radiotherapy (n = 781, from 46 units). Only 14 patients (1%) tested positive for SARS-CoV-2 during their treatment journey. Conclusions The majority of ‘COVID-altered’ management decisions were largely in line with pre-COVID evidence-based guidelines, implying that breast cancer survival outcomes are unlikely to be negatively impacted by the pandemic. However, in this study, the potential impact of delays to BC presentation or diagnosis remains unknown.

Introduction: Women considering immediate breast reconstruction (IBR) after mastectomy for breast cancer require high-quality information about the short and long-term clinical outcomes of different procedure types, including the need for further surgery, to allow them to make fully informed decisions about their breast reconstruction options. Long-term outcome data is currently lacking. The UK Brighter population-based cohort study aimed to compare the need for revisional surgery and secondary reconstruction by type of IBR at a minimum of 12 years following the index procedure to support informed decision-making. Methods: Women who underwent unilateral mastectomy and IBR for invasive breast cancer or ductal carcinoma in situ (DCIS) in England between 1 April 2008 and 31 March 2009 were identified using National Health Service (NHS) Hospital Episode Statistics (HES). Lists of procedure codes indicating revisional surgery, defined as operations performed to the same site as the index reconstruction and/or the donor site (if appropriate), excluding a single planned implant exchange in the expander group, or secondary reconstruction, defined as the replacement of one reconstruction with another, with or without a period of being flat, were iteratively developed and refined. Numbers of revision procedures and secondary reconstructions were compared by type of index reconstruction. Multivariable regression was used to control for potential confounders. Results: 2,260 women underwent IBR during the study period including 742 (32.8%) expander/implant (EI), 1,146 (50.7%) latissimus dorsi (LD) flap reconstructions with (n=649) and without (n=497) an implant and 372 (16.5%) abdominal free-flap (AFF) procedures. Women receiving reconstructions involving implants were significantly more likely to require more revisions over time, with 201/742 (27.1%) patients undergoing EI reconstruction and 154/649 (23.7%) those receiving an implant-assisted LD reconstruction requiring two or more post-reconstruction revision procedures compared with 77/497 (15.5%) patients undergoing autologous LD and 59/372 (15.9%) patients receiving AFF procedures (p< 0.001). Undergoing primary reconstructive surgery before the age of 50, and region of residence at the time of the mastectomy were factors influencing revisional surgery in the multivariable regression analysis. By 12 years, 128/742 (17.3%) of women who initially underwent an expander/implant reconstruction had received a secondary reconstruction compared with 34/1146 (3.0%) patients who had initially received an LD +/- implant procedure and 11/372 (3.0%) patients initially undergoing an AFF reconstruction (p< 0.001). Conclusions: The need for revisional surgery in women electing to undergo IBR involving implants is significantly greater than that for women electing to receive autologous reconstructions and almost 1 in 5 women undergoing primary EI reconstruction required a secondary reconstruction by 12 years. These findings should be shared with women considering IBR to support informed decision making and with healthcare providers and commissioners to support the provision of high-quality, evidence-based reconstructive care. Citation Format: Leigh Johnson, Paul White, Ranjeet Jeevan, John Browne, Carmel Gulliver-Clarke, Joe O’Donoghue, Syed Mohiuddin, William Hollingworth, Patricia Fairbrother, Mairead MacKenzie, Chris Holcombe, Shelley Potter. PD15-10 Impact of procedure type on long-term revisional surgery and secondary reconstruction following immediate breast reconstruction: The UK Brighter national population-based cohort study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD15-10.

Background Breast conserving surgery with adjuvant radiotherapy (BCS+RT) and mastectomy are currently offered as oncologically equivalent options for the surgical management of early breast cancer based on findings from randomised controlled trials (RCTs) conducted over four decades ago. Since then, locoregional and systemic breast cancer treatments have improved significantly and several recent observational studies suggest a survival advantage in patients receiving BCS+RT compared to those having mastectomy. If BCS+RT is oncologically superior to mastectomy, this may dramatically impact surgical treatment recommendations. The aim of this systematic review was to identify, critically appraise and summarise the contemporary literature comparing survival following BCS+RT and mastectomy to inform surgical decision-making for patients with early breast cancer. Methods A systemic search of MEDLINE, Cochrane Central Register of Controlled Trials and Embase identified studies published between 1st January 2000 to 22nd September 2021. Included were primary research studies published in English comparing overall survival in women undergoing primary surgery with either BCS+RT or mastectomy for unilateral stage I to III breast cancer. Excluded were studies evaluating neoadjuvant chemotherapy; rare breast cancer subtypes (e.g. mucinous) or in specific patient populations (e.g. pregnancy associated breast cancer) and those that completed recruitment before 1st January 1990. We used the ROBINS-I tool to assess the risk of bias in study results and GRADE to assess the overall certainty of evidence. All papers without critical risk of bias were included in a quantitative meta-analysis. Where more than one study reported outcomes in overlapping population-based registry cohorts, the study with the most recent data on the largest cohort was selected for analysis. The primary analysis was a random effects meta-analysis with a fixed effect model undertaken as sensitivity analysis. A secondary meta-analysis was performed for studies only including triple negative breast cancers. All analyses were conducted using STATA17. Results 10,876 abstracts were screened and 157 full-text papers assessed for eligibility, of which 93 (17 multi-centre observational studies, 30 were single-centre observational studies and 46 registry-based studies) met the inclusion criteria for the review. 25 papers were excluded from meta-analysis due to an overall critical risk of confounder bias and 27 were excluded due overlapping study populations. 36 studies (34 with serious risk of bias and 2 with moderate risk of bias) reporting survival outcomes on 1,321,291 patients (729,789 undergoing BCS+RT and 591,502 undergoing mastectomy) were included in the meta-analysis. The pooled hazard ratio was 0.72 (95% CI 0.64– 0.81, p< 0.001, I2 97.6%) demonstrating improved overall survival for patients undergoing BCS+RT compared with those receiving mastectomy. The sensitivity analysis, using a fixed effect model, showed a hazard ratio of 0.88 (95% CI 0.87 – 0.89, p< 0.001, I2 97.6%) for survival in women undergoing BCS+RT compared with mastectomy. Meta-analysis of 8 studies reporting survival in 17,181 patients with triple negative breast cancer showed a hazard ratio of 0.73 (95% CI 0.68 – 0.79), p< 0.001, I2 34.7%) for those receiving BCS+RT versus mastectomy. Discussion This meta-analysis provides further, albeit very low certainty evidence, that overall survival is improved following BCS+RT compared with mastectomy in a contemporary cohort of patients treated for early-stage breast cancer. These results should be interpreted with caution due to the heterogeneity of included studies and the high risk of bias associated with observational data. As future RCTs will not be feasible, well-designed large-scale prospective observational studies are needed to provide better evidence to support surgical decision-making in early-stage breast cancer. Citation Format: Kiran Kasper Rajan, Katherine Fairhurst, Beth Birkbeck, Rebecca Wilson, Jelena savovic, Chris Holcombe, Shelley Potter. PD15-04 Overall survival following breast conserving surgery and adjuvant radiotherapy compared with mastectomy for early stage breast cancer: a systematic review and meta-analysis [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD15-04.

Background SMALL (ISRCTN 12240119) is a novel UK phase III multicentre randomised trial comparing vacuum-assisted excision (VAE) to surgery for small screen-detected breast cancers with biologically favourable characteristics. Acceptance by the clinical community and recruitment to SMALL was anticipated to be challenging as it involves randomisation, surgical de-escalation and minimally-invasive percutaneous treatment (VAE). A QuinteT Recruitment Intervention (QRI) has therefore been integrated throughout SMALL’s recruitment period, with the aim of optimising recruitment and informed consent. Methods The QRI in SMALL has involved the analysis of: a) screening log data b) written views from recruiters on the two treatments and their advantages/disadvantages c) in-depth semi-structured interviews with members of the Trial Management Group (TMG) and clinician-recruiters and d) audio-recordings of recruitment discussions with potentially eligible patients. Recruitment challenges were identified and addressed through the provision of written recruitment tips documents, and group and individual feedback sessions with recruiters. Results There was widespread support for the concept of the SMALL trial within the clinical community. Recruiters recognised the pioneering role of SMALL as the only current surgical de-escalation randomised trial in screen-detected breast cancer. Key recruitment challenges revolved around i) healthcare professionals (HCPs) who met patients early in the pathway providing information indicating that they were being referred for surgery (without mentioning SMALL or VAE), ii) concerns around the balance of de-escalation/escalation of different treatment modalities (e.g. some clinicians may prefer to de-escalate radiotherapy in preference to surgery in low-risk patients), iii) challenges in articulating equipoise in a surgical de-escalation trial, iv) patient preferences (primarily for surgery) and recruiter discomfort in exploring/addressing such preferences and v) fewer eligible patients than anticipated. QRI actions to overcome these issues included developing a tips document for HCPs meeting patients early in the pathway, highlighting the need to refrain from making treatment recommendations. A more generic tips document was also developed emphasising the importance of the early introduction of the study, provision of balanced information about both treatments, encouraging recruiters to engage with patients’ concerns and preferences, and adequate explanation of randomisation. Group and individual feedback sessions focussed on two key areas – articulating equipoise through balanced information provision, and considering optimal ways to explore patient preferences where they are expressed. Despite the many set-up and recruitment challenges that arose from opening at the start of the pandemic, SMALL has recruited 142 patients to date from 23 sites, with an approached to randomised patient ratio of ~50%. Conclusion SMALL is a novel surgical de-escalation study in breast cancer, which will provide critical evidence to support reductions in treatment of good prognosis disease. Using a range of qualitative methodology, the QRI has identified both broad support for the study within the clinical community, but has also identified barriers to recruitment at both clinician and patient level. These challenges have been addressed employing a range of methods, and the recruitment level and approach/randomised ratio shows the overall acceptability of this study to patients. Further work will involve interviews with patients, with a focus on their views on de-escalation, and further recruiter feedback sessions. Taken together, theis data will help inform the development and design of future de-escalation and treatment optimisation studies in breast cancer. SMALL is funded by the UK NIHR HTA programme, award 17/42/32 Citation Format: Stuart A. McIntosh, Charlotte E. Coles, David Dodwell, Kenneth Elder, Jessica Foster, Claire Gaunt, Amanda Kirkham, Iain Lyburn, Jenna Morgan, Sarah E. Pinder, Sarah Pirrie, Shelley Potter, Tracy Roberts, Nisha Sharma, Hilary Stobart, Elizabeth Southgate, Sian Taylor-Phillips, Matthew Wallis, Daniel Rea, Sangeetha Paramasivan. Recruitment challenges in a UK surgical de-escalation study: preliminary qualitative research findings from the SMALL trial [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-17.

Background Prepectoral breast reconstruction (PPBR) has recently been introduced to reduce postoperative pain and improve cosmetic outcomes in women having implant-based procedures. High-quality evidence to support the practice of PPBR, however, is lacking. Pre-BRA is an IDEAL stage 2a/2b study that aimed to establish the safety, effectiveness, and stability of PPBR before definitive evaluation in an RCT. The short-term safety endpoints at 3 months after surgery are reported here. Methods Consecutive patients electing to undergo immediate PPBR at participating UK centres between July 2019 and December 2020 were invited to participate. Demographic, operative, oncology, and complication data were collected. The primary outcome was implant loss at 3 months. Other outcomes of interest included readmission, reoperation, and infection. Results Some 347 women underwent 424 immediate implant-based reconstructions at 40 centres. Most were single-stage direct-to-implant (357, 84.2 per cent) biological mesh-assisted (341, 80.4 per cent) procedures. Conversion to subpectoral reconstruction was necessary in four patients (0.9 per cent) owing to poor skin-flap quality. Of the 343 women who underwent PPBR, 144 (42.0 per cent) experienced at least one postoperative complication. Implant loss occurred in 28 women (8.2 per cent), 67 (19.5 per cent) experienced an infection, 60 (17.5 per cent) were readmitted for a complication, and 55 (16.0 per cent) required reoperation within 3 months of reconstruction. Conclusion Complication rates following PPBR are high and implant loss is comparable to that associated with subpectoral mesh-assisted implant-based techniques. These findings support the need for a well-designed RCT comparing prepectoral and subpectoral reconstruction to establish best practice for implant-based breast reconstruction.

ObjectiveOutcome selection and reporting in studies of novel surgical procedures and devices lacks standardisation, hindering safe and effective evaluation. A core outcome set (COS) to measure and report in all studies of surgical innovation is needed. We explored outcomes in a specific sample of innovative surgical device case studies to identify outcome domains specifically relevant to innovation to inform the development of a COS.DesignA targeted review of 11 purposive selected case studies of innovative surgical devices.MethodsElectronic database searches in PubMed (July 2018) identified publications reporting the introduction and evaluation of each device. Outcomes were extracted and categorised into domains until no new domains were conceptualised. Outcomes specifically relevant to evaluating innovation were further scrutinised.Results112 relevant publications were identified, and 5926 outcomes extracted. Heterogeneity in study type, outcome selection and reporting was observed across surgical devices. Categorisation of outcomes was performed for 2689 (45.4%) outcomes into five broad outcome domains. Outcomes considered key to the evaluation of innovation (n=66; 2.5%) were further categorised as surgeon/operator experience (n=40; 1.5%), unanticipated events (n=15, 0.6%) and modifications (n=11; 0.4%).ConclusionOutcome domains unique to evaluating innovative surgical devices have been identified. Findings have been combined with multiple other data sources relevant to the evaluation of surgical innovation to inform the development of a COS to measure and report in all studies evaluating novel surgical procedures/devices.

Introduction\ud \ud Evidence based guidelines for the optimal management of breast cancer locoregional recurrence (LRR) are limited, with potential for variation in clinical practice. This national practice questionnaire (NPQ) was designed to establish the current practice of UK breast multidisciplinary teams (MDTs) regarding LRR management.\ud \ud \ud \ud Methods\ud \ud UK breast units were invited to take part in the MARECA study MDT NPQ. Scenario-based questions were used to elicit preference in pre-operative staging investigations, surgical management, and adjuvant therapy.\ud \ud \ud \ud Results\ud \ud 822 MDT members across 42 breast units (out of 144; 29%) participated in the NPQ (February–August 2021). Most units (95%) routinely performed staging CT scan, but bone scan was selectively performed (31%).\ud \ud \ud \ud For patients previously treated with breast conserving surgery (BCS) and radiotherapy, few units (7%) always/usually offered repeat BCS. However, in the absence of radiotherapy, most units (90%) always/usually offered repeat BCS. For patients presenting with isolated local recurrence following previous BCS and SLNB (sentinel lymph node biopsy), most units (95%) advocated repeat SLNB. Where SLNs could not be identified, 86% proceeded to a four-node axillary sampling procedure.\ud \ud \ud \ud For ER positive, HER2 negative, node negative local recurrence, 10% of units always/usually offered chemotherapy. For ER positive, HER2 negative, node positive local recurrence, this recommendation increased to 64%. For triple negative breast cancer local recurrence, 90% of units always/usually offered chemotherapy.\ud \ud \ud \ud Conclusion\ud \ud This survey has highlighted where consistencies and variations exist in the multidisciplinary management of breast cancer LRR. However, further research is required to determine how these management patterns influence patient outcomes, which will further refine optimal treatment pathways.

ObjectiveDuring development of complex surgical innovations, modifications occur to optimize safety and efficacy. Operators’ experiences (how professionals feel undertaking the innovation) drives this process but comprehensive overviews of measures of this concept are lacking. This study identified and appraised measures to assess operators’ experience of surgical innovation.Study design and settingThere were three phases: 1) Literature reviews identified measures of operators’ experience and concepts measured were extracted and grouped into domains. 2) Quality appraisal was conducted to assess content validity of identified instruments, and was supported by COSMIN methodology. Self-reported measurement instruments that had underdone formal development were eligible. Content validity was assessed using COSMIN criteria for good content validity (rated sufficient/insufficient/indeterminate/inconsistent), informed by standards for measurement development and domains identified in phase 1. 3) Instruments determined suitable and of sufficient quality underwent supplemental appraisal in interviews with international multi-disciplinary professionals and a focus group.ResultsLiterature reviews identified 16 measurement instruments from 243 studies. Most assessed ‘psychological’ experiences and ‘usability’. No instrument was specifically validated for innovative surgery. Three instruments were rated ‘sufficient’ (SURG-TLX) or ‘indeterminate’ (STAI,ISAT). Twenty professionals were interviewed (7 female; 15 specialties; 6 countries) and the focus group included 10 participants (4 professionals, 6 researchers). The SURG-TLX was considered the most relevant, comprehensive, and comprehensible instrument.ConclusionThe SURG-TLX is preliminarily recommended to measure operators’ experiences of innovation. Further work exploring its role and impact on surgical innovation is required.

To better understand how to support UK breast surgeons in clinical trial participation and recruitment, the Association of Breast Surgery (ABS) Academic and Research (A&R) Committee surveyed the ABS membership on the challenges and barriers surrounding the recruitment of patients to breast cancer clinical trials. Improving patient outcomes depends on better engagement with clinical research.

Background Immediate implant‐based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK, but almost one in ten women experience implant loss and reconstructive failure after this technique. Little is known about how implant loss impacts on patients' quality of life. The first phase of the Loss of implant Breast Reconstruction (LiBRA) study aimed to use qualitative methods to explore women's experiences of implant loss and develop recommendations to improve care. Methods Semistructured interviews were conducted with a purposive sample of women who experienced implant loss after immediate IBBR, performed for malignancy or risk reduction across six centres. Interviews explored decision‐making regarding IBBR, and experiences of implant loss and support received. Thematic analysis was used to explore the qualitative interview data. Sampling, data collection and analysis were undertaken concurrently and iteratively until data saturation was achieved. Results Twenty‐four women were interviewed; 19 had surgery for malignancy and five for risk reduction. The median time between implant loss and interview was 42 (range 22–74) months. Ten women had undergone secondary reconstruction, two were awaiting surgery, and 12 had declined further reconstruction. Three key themes were identified: the need for accurate information about the risks and benefits of IBBR; the need for more information about ‘early‐warning’ signs of postoperative problems, to empower women to seek help; and better support following implant loss. Conclusion Implant loss is a devastating event for many women. Better preoperative information and support, along with holistic patient‐centred care when complications occur, may significantly improve the experience and outcome of care., Immediate implant‐based breast reconstruction is the most commonly performed reconstructive procedure worldwide after mastectomy for breast cancer, but up to one in ten women experience implant loss and reconstructive failure after this technique. This qualitative study explores the experiences of 24 women experiencing implant loss from six centres across the UK. It highlights the need for more balanced presentation of the risks and benefits of different techniques to inform decision‐making, the need for better information regarding the early signs of potential problems to empower women to seek help, and more support for patients experiencing this potentially devastating complication. Patients need better support

BackgroundBreast reconstruction (BR) is performed to improve outcomes for patients undergoing mastectomy. A recently developed core outcome set for BR includes six patient-reported outcomes that should be measured and reported in all future studies. It is vital that any instrument used to measure these outcomes as part of a core measurement set be robustly developed and validated so data are reliable and accurate. The aim of this systematic review is to evaluate the development and measurement properties of existing BR patient-reported outcome measures (PROMs) to inform instrument selection for future studies.MethodsA PRISMA-compliant systematic review of development and validation studies of BR PROMs was conducted to assess their measurement properties. PROMs with adequate content validity were assessed using three steps: (1) the methodological quality of each identified study was assessed using the COSMIN Risk of Bias checklist; (2) criteria were applied for assessing good measurement properties; and (3) evidence was summarized and the quality of evidence assessed using a modified GRADE approach.ResultsFourteen articles reported the development and measurement properties of six PROMs. Of these, only three (BREAST-Q, BRECON-31, and EORTC QLQ-BRECON-23) were considered to have adequate content validity and proceeded to full evaluation. This showed that all three PROMs had been robustly developed and validated and demonstrated adequate quality.ConclusionsBREAST-Q, BRECON-31, and EORTC QLQ-BRECON-23 have been well-developed and demonstrate adequate measurement properties. Work with key stakeholders is now needed to generate consensus regarding which PROM should be recommended for inclusion in a core measurement set.

Introduction: Potential advantages of neoadjuvant systemic therapy (NST) include downstaging disease to minimise surgery, and in vivo assessment of tumour sensitivity to therapeutic drugs. Considerable variation in NST use remains, however, and it is unclear whether pathological response rates reflect those reported in trials, or whether downstaging achieved impacts on surgical decision-making. The NeST prospective multicentre study will address these questions through investigating patterns of care in the UK. Methods: Women undergoing NST as their primary breast cancer treatment (chemotherapy (CT), endocrine (ET) and targeted therapies) in UK centres between December 2017 and November 2018 were included. Anonymised data was collected at 37 participating centres, and uploaded to REDCap. Results: 1179 patients received neoadjuvant treatment during the study period. 41% had HER2+ disease, 28% TNBC and 31% ER+ HER2- disease. 48% were node positive and 52% node negative. Cited indications for neoadjuvant treatment were (more than one option applicable to each patient): Downstaging (mastectomy to breast conservation) 37% Facilitate dual antiHER2 therapy 33% Inoperable disease 19% Improved cosmesis (reduced volume of excision) 17% Facilitate BRCA testing 9% Inflammatory breast cancer 6% In patients recommended to receive NST, the MDT decision was for neoadjuvant CT in 87% of cases and neoadjuvant ET in 13%. For ER+ disease, the commonest reasons for prescribing CT were high grade disease and pre-menopausal status. The majority were treated with anthracycline-taxane combinations. 21% of TNBC patients were treated with platinum-containing regimens. In HER2+ disease, 54% were treated with dual antiHER2 therapies/chemotherapy, with 10% receiving chemotherapy/single antiHER2 agent (trastuzumab). Centres were asked to indicate primary breast surgical treatment recommended prior to/without NST. At abstract submission, this data was available for 887 patients. 31 had inoperable disease. A total of 477 were considered to require mastectomy, with disease not amenable to breast conservation surgery (BCS). A further 379 patients were considered candidates for BCS. Data on final surgical procedure was available for 765 patients. Of those patients determined suitable only for mastectomy at diagnosis, 123 underwent BCS as their primary operation - a downstaging rate of 26%. The overall mastectomy rate in this cohort was 48%, with 33% having mastectomy and 15% mastectomy with immediate reconstruction. Pathological response data was available in 672 patients, with an overall pathological complete response (pCR) rate of 29% (defined as no residual invasive or in situ disease). pCR rate according to molecular subtype was 37% for HER2+ disease, 35% for TNBC and 7% for ER+, HER2-ve disease. The pCR rate in patients downstaged from mastectomy to BCS was 27%. Conclusions: This UK national prospective study suggests that surgical downstaging remains a key indication for the use of NST. This is reflected in the fact that 26% of patients in this series were downstaged from an original surgical plan for mastectomy, with NST enabling BCS in these patients. However, based on this data it appears that surgical downstaging is no more likely in those with pCR compared to those without a pCR. Additional indications for NST are emerging, according to disease biology. There is widespread use of dual antiHER2 targeted therapies in this setting, with increasing use of platinum-containing regimens for TNBC. Neoadjuvant CT continues to be frequently used in the treatment of ER+ disease, despite known low pCR rates in this context, which are again confirmed. Low rates of neoadjuvant ET use are reported. Data collection is ongoing; updated data will be presented in December 2019. Citation Format: Stuart A McIntosh, Gareth W Irwin, Finian Bannon, Charlotte Coles, Ellen Copson, Ramsey Cutress, Rajiv Dave, Margaret Grayson, Chris Holcombe, Sheeba Irshad, Ciara O'Brien, Rachel O'Connell, Carlo Palmieri, Abeer M Shaaban, Nisha Sharma, Jagdeep Singh, Ian Whitehead, Shelley Potter. National utilisation of neoadjuvant systemic therapy and impact on surgical treatment - A prospective multi-centre cohort study [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-16-04.

Introduction: Approximately 55,000 women in the United Kingdom are diagnosed with new breast cancer annually. Since emerging in December 2019, SARS-CoV-2 (coronavirus disease 2019, COVID-19) has become a global pandemic, affecting healthcare delivery worldwide. In response to the pandemic, multiple guidelines were issued to assist with rationalising breast cancer care. The primary aim of the B-MaP-C study is to audit and describe breast cancer management of patients newly diagnosed with breast cancer during the COVID-19 pandemic against pre-COVID-19 management practice in the UK. The implications of changes to management will be determined and the impact of a COVID-19 diagnosis on the patient's breast cancer management will be determined. Methods and analysis: This is a multi-centre collaborative audit of consecutive breast cancer patients undergoing treatment decisions during the acute and recovery phases of the COVID-19 pandemic. All patients with newly diagnosed primary breast cancer, whose treatment was decided in a multidisciplinary meeting from the 16th March 2020, are eligible for inclusion. Ethics and dissemination: As this is an audit ethical approval is not required. Each participating centre is required to register the study locally and obtain local governance approvals prior to commencement of data collection. Local audit data will be available to individual participating units for governance purposes. The results of the data analysis will be submitted for publication, as well as disseminated via the ABS newsletter and a webinar. All data will be presented at national and international conferences, circumstances permitting. Registration details: Each participating centre received local governance audit registration.