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.

Mastitis and Mammary Abscess Management Audit (MAMMA) in the UK and Ireland.

BACKGROUND: The aim of this multicentre prospective audit was to describe the current practice in the management of mastitis and breast abscesses in the UK and Ireland, with a specific focus on rates of surgical intervention. METHODS: This audit was conducted in two phases from August 2020 to August 2021; a phase 1 practice survey and a phase 2 prospective audit. Primary outcome measurements for phase 2 included patient management pathway characteristics and treatment type (medical/radiological/surgical). RESULTS: A total of 69 hospitals participated in phase 2 (1312 patients). The key findings were a high overall rate of incision and drainage (21.0 per cent) and a lower than anticipated proportion of ultrasound-guided aspiration of breast abscesses (61.0 per cent). Significant variations were observed regarding the rate of incision and drainage (range 0-100 per cent; P < 0.001) and the rate of needle aspiration (range 12.5-100 per cent; P < 0.001) between individual units. Overall, 22.5 per cent of patients were admitted for inpatient treatment, out of whom which 72.9 per cent were commenced on intravenous antibiotics. The odds of undergoing incision and drainage for a breast abscess or being admitted for inpatient treatment were significantly higher if patients presented at the weekend compared with a weekday (P ≤ 0.023). Breast specialists reviewed 40.9 per cent of all patients directly, despite the majority of patients (74.2 per cent) presenting within working hours on weekdays. CONCLUSIONS: Variation in practice exists in the management of mastitis and breast abscesses, with high rates of incision and drainage in certain regions of the UK. There is an urgent need for a national best-practice toolbox to minimize practice variation and standardize patient care.

Mastitis and breast abscess is a painful infection of the breast. It is an extremely common breast problem. One in three women can get this condition at some stage in their life. To treat a breast abscess, the pus inside should be drained out of the body. This can be done either by cutting into the breast using surgery or by inserting a fine needle using an ultrasonography scan (which uses ultrasound). Fine-needle drainage has the benefit that it does not require admission to hospital. Surgery can cause the breast to look misshapen. It is unknown which method is used more often in the UK and Ireland. The aim of this study was to describe how mastitis and breast abscesses are treated in the UK and Ireland. This study involved a survey of practice (phase 1) and collection of data, which are routinely recorded for these patients (phase 2). This study involved 69 hospitals and 1312 patient records. One in five women had an operation for a breast abscess. This was higher than expected. Six in 10 women had a pus drainage using a fine needle. The chance of having an operation depended on the hospital. Women that came to hospital at the weekend were almost twice as likely to have an operation. One in five women were admitted to hospital. The chances of that more than doubled if a woman came to hospital at the weekend. There are differences in treatment of mastitis and breast abscesses across the UK and Ireland. Changes need to be put in place to make access to treatment more equal.

A Core Outcome Set for Seamless, Standardized Evaluation of Innovative Surgical Procedures and Devices (COHESIVE): A Patient and Professional Stakeholder Consensus Study.

OBJECTIVE: To develop a COS, an agreed minimum set of outcomes to measure and report in all studies evaluating the introduction and evaluation of novel surgical techniques. SUMMARY OF 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: A total of 7972 verbatim outcomes were identified, categorized into 32 domains, and formatted into survey items/questions. Four hundred ten 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. Twelve outcomes were scored "consensus in" ("very important" by ≥70% of patients and professionals) and 20 "no consensus." A consensus meeting, involvingcontext: modifications, unexpected disadvantages, device problems, technical procedure completion success, patients' experience relating to the procedure being innovative, surgeons'/operators' experience. Other domains relate to intended benefits, whether the overall desired effect was achieved and expected disadvantages. CONCLUSIONS: The COS is recommended for use in all studies before definitive randomized controlled trial evaluation to promote safe, transparent, and efficient surgical innovation.

Current practice and provision of oncoplastic breast-conserving surgery in the UK: results of the ANTHEM national practice questionnaire.

PURPOSE: Oncoplastic breast-conserving surgery (OPBCS) may be a better option than mastectomy ± immediate breast reconstruction (IBR) for women with breast cancer but studies directly comparing the techniques are lacking. We surveyed UK breast units to determine the current practice of OPBCS to inform the design of a future comparative study. METHODS: An electronic survey was developed to explore the current practice of OPBCS. This included the local availability of volume displacement and/or replacement techniques; number of cases performed; contraindications and approach to contralateral symmetrisation. Summary data for each survey item were calculated and overall provision of care examined. RESULTS: 58 UK centres completed the survey, including 43 (74%) stand-alone breast and 15 (26%) combined breast/plastics units. Over 40% of units (n = 24) treated more than 500 cancers/year. Most units offered volume displacement techniques (TMs) (97%). Over two-thirds (n = 39. 67%) of units offered local perforator flaps (LPF). Approximately a half of units (10/19) not performing LPF were planning to introduce them in the next 12-24 months. A third (n = 19, 33%) of units routinely performed simultaneous contralateral symmetrisation mostly with two-surgeon operating. There were limited oncological restrictions to OPBCS with no contraindications for multifocal cancers in most centres; 65% of units (36/55) offered OPBCS for multicentric disease. Extensive DCIS was a contraindication in a minority of units. CONCLUSIONS: OPBCS is widely available in the UK but contraindications and approaches to contralateral symmetrisation were variable. Work is now needed to prospectively evaluate the outcomes of OPBCS vs mastectomy ± IBR to support informed decision-making.

Identifying research priorities in breast cancer surgery: a UK priority setting partnership with the James Lind Alliance.

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.

Bridging pre-surgical endocrine therapy for breast cancer during the COVID-19 pandemic: outcomes from the B-MaP-C study.

PURPOSE: The B-MaP-C study investigated changes to breast cancer care that were necessitated by the COVID-19 pandemic. Here we present a follow-up analysis of those patients commenced on bridging endocrine therapy (BrET), whilst they were awaiting surgery due to reprioritisation of resources. METHODS: This multicentre, multinational cohort study recruited 6045 patients from the UK, Spain and Portugal during the peak pandemic period (Feb-July 2020). Patients on BrET were followed up to investigate the duration of, and response to, BrET. This included changes in tumour size to reflect downstaging potential, and changes in cellular proliferation (Ki67), as a marker of prognosis. RESULTS: 1094 patients were prescribed BrET, over a median period of 53 days (IQR 32-81 days). The majority of patients (95.6%) had strong ER expression (Allred score 7-8/8). Very few patients required expedited surgery, due to lack of response (1.2%) or due to lack of tolerance/compliance (0.8%). There were small reductions in median tumour size after 3 months' treatment duration; median of 4 mm [IQR - 20, 4]. In a small subset of patients (n = 47), a drop in cellular proliferation (Ki67) occurred in 26 patients (55%), from high (Ki67 ≥ 10%) to low (< 10%), with at least one month's duration of BrET. DISCUSSION: This study describes real-world usage of pre-operative endocrine therapy as necessitated by the pandemic. BrET was found to be tolerable and safe. The data support short-term (≤ 3 months) usage of pre-operative endocrine therapy. Longer-term use should be investigated in future trials.

Secondary healthcare costs after mastectomy and immediate breast reconstruction for women with breast cancer in England: population-based cohort study.

BACKGROUND: Immediate breast reconstruction after mastectomy can improve the quality of life for women with breast cancer and rates are increasing. Long-term inpatient costs of care were estimated to understand the impact of different immediate breast reconstruction procedures on healthcare expenditure. METHODS: Hospital Episode Statistics Admitted Patient Care data were used to identify women undergoing unilateral mastectomy and immediate breast reconstruction in English National Health Service hospitals (1 April 2009 to 31 March 2015) and any subsequent procedures performed to revise, replace, or complete the breast reconstruction. Costs were assigned to Hospital Episode Statistics Admitted Patient Care data using the Healthcare Resource Group 2020/21 National Costs Grouper. Generalized linear models were used to estimate mean cumulative costs for five immediate breast reconstruction procedures over 3 and 8 years, adjusting for covariates (age/ethnicity/deprivation). RESULTS: A total of 16 890 women underwent mastectomy and immediate breast reconstruction: implant (5192; 30.7 per cent), expander (2826; 16.7 per cent), autologous latissimus dorsi flap (2372; 14.0 per cent), latissimus dorsi flap with expander/implant (3109; 18.4 per cent), and abdominal free-flap reconstruction (3391; 20.1 per cent). The mean (95 per cent c.i.) cumulative cost was lowest for latissimus dorsi flap with expander/implant reconstruction (€20 103 (€19 582 to €20 625)) over 3 years and highest for abdominal free-flap reconstruction (€27 560 (€27 037 to €28 083)). Over 8 years, expander (€29 140 (€27 659 to €30 621)) and latissimus dorsi flap with expander/implant (€29 312 (€27 622 to €31 003)) reconstructions were the least expensive, while abdominal free-flap reconstruction (€34 536 (€32 958 to €36 113)) remained the most expensive, despite having lower costs for revisions and secondary reconstructions. This was driven primarily by the cost of the index procedure (€5435 (expander reconstruction) to €15 106 (abdominal free-flap reconstruction)). CONCLUSION: Hospital Episode Statistics Admitted Patient Care Healthcare Resource Group data provided a comprehensive longitudinal cost assessment of secondary care. Although abdominal free-flap reconstruction was the most expensive option, higher costs of the index procedure need to be balanced against ongoing long-term costs of revisions/secondary reconstructions, which are higher after implant-based procedures.

Impact of procedure type on revisional surgery and secondary reconstruction after immediate breast reconstruction in a population-based cohort.

BACKGROUND: Women considering immediate breast reconstruction require high-quality information about the likely need for secondary reconstruction and the long-term risk of revisional surgery to make fully informed decisions about different reconstructive options. Such data are currently lacking. This study aimed to explore the impact of reconstruction type on the number of revisions and secondary reconstructions performed 3, 5, and 8 years after immediate breast reconstruction in a large population-based cohort. METHODS: Women undergoing unilateral mastectomy and immediate breast reconstruction for breast cancer or ductal carcinoma in situ in England between 1 April 2009 and 31 March 2015 were identified from National Health Service Hospital Episode Statistics. Numbers of revisions and secondary reconstructions in women undergoing primary definitive immediate breast reconstruction were compared by procedure type at 3, 5, and 8 years after index surgery. RESULTS: Some 16 897 women underwent immediate breast reconstruction with at least 3 years' follow-up. Of these, 14 069 had a definitive reconstruction with an implant only (5193), latissimus dorsi flap with (3110) or without (2373) an implant, or abdominal free flap (3393). Women undergoing implant-only reconstruction were more likely to require revision, with 69.5 per cent (747 of 1075) undergoing at least one revision by 8 years compared with 49.3 per cent (1568 of 3180) in other reconstruction groups. They were also more likely to undergo secondary reconstruction, with the proportion of women having further reconstructive procedures increasing over time: 12.8 per cent (663 of 5193) at 3 years, 14.3 per cent (535 of 3752) at 5 years, and 17.6 per cent (189 of 1075) at 8 years. CONCLUSION: Long-term rates of revisions and secondary reconstructions were considerably higher after primary implant-based reconstruction than autologous procedures. These results should be shared with patients to support informed decision-making.

BACKGROUND: Breast reconstruction is performed to improve well-being for women who need mastectomy (removal of the breast) as part of breast cancer treatment. There are many different types of breast reconstruction operation, and it can be difficult for women to decide which operation, if any, is right for them. Information about the number of extra operations that a woman is likely to need after breast reconstruction surgery is an important factor in helping them make this decision. This study aimed to investigate the number of extra operations that women who had breast reconstruction needed by 3, 5, and 8 years after surgery, and how this differed by the type of breast reconstruction surgery they had. Routinely collected hospital record data were used to identify women having breast reconstruction at the time of mastectomy for breast cancer, and identify any extra operations performed for problems related to the reconstruction in the 8 years after the first operation. The number of extra operations performed after different types of breast reconstructions was compared at 3, 5, and 8 years after the mastectomy. Women who had implant-based reconstruction required more extra operations than those having reconstruction using their own tissue. They were also more likely to have the implant replaced with another type of breast reconstruction than women undergoing tissue-based reconstruction at 3, 5, and 8 years after the first surgery. This information should be discussed with women thinking about breast reconstruction to help them decide what type of operation would be best for them.

Long-term patient-reported outcomes of immediate breast reconstruction after mastectomy for breast cancer: population-based cohort study.

BACKGROUND: Breast reconstruction is offered to improve quality of life for women after mastectomy for breast cancer, but information regarding the long-term patient-reported outcomes of different reconstruction procedures is currently lacking. The Brighter study aimed to evaluate long-term patient-reported outcomes after immediate breast reconstruction (IBR) in a population-based cohort. METHODS: Women who underwent mastectomy with IBR for breast cancer in England between 1 January 2008 and 31 March 2009 were identified from National Health Service Hospital Episode Statistics. Surviving women were invited to complete the BREAST-Q, EQ-5D-5L™, and ICECAP-A at least 12 years after the index procedure. Questionnaires were scored according to developers' instructions and compared by IBR type. RESULTS: Some 1236 women underwent IBR; 343 (27.8 per cent) had 2-stage expander/implant, 630 (51.0 per cent) latissimus dorsi, and 263 (21.3 per cent) abdominal flap reconstructions, with a mean(s.d.) follow-up of 13.3(0.5) years. Women who underwent abdominal flap reconstruction reported higher scores in all BREAST-Q domains than those who had other procedures. These differences remained statistically significant and clinically meaningful after adjusting for age, ethnicity, geographical region, socioeconomic status, smoking, BMI, and complications. The greatest difference was seen in scores for satisfaction with breasts; women who had abdominal flap reconstructions reported scores that were 13.17 (95 per cent c.i. 9.48 to 16.87) points; P < 0.001) higher than those among women who had two-stage expander/implant procedures. Women who underwent latissimus dorsi reconstruction reported significantly more pain/discomfort on the EQ-5D-5L™, but no other differences between procedures were seen. CONCLUSION: Long-term patient-reported outcomes are significantly better following abdominal flap reconstruction than other traditional procedure types. These findings should be shared with women considering IBR to help them make informed decisions about their surgical options.

The Impact of Radiotherapy on Patient-reported Outcomes of Immediate Implant-based Breast Reconstruction With and Without Mesh.

OBJECTIVE: To explore the impact of PMRT on PROs of IBBR performed with and without mesh. SUMMARY OF BACKGROUND DATA: PMRT is increasingly given to improve breast cancer outcomes but can adversely impact complications after IBBR.Little; however, is known about the impact of PMRT on the PROs of IBBR, especially when mesh is used. METHODS: The implant Breast Reconstruction evAluation prospective cohort study recruited consecutive women undergoing immediate IBBR from 81 UK breast and plastic surgical units. Demographic, operative, oncological, and 3-month complication data were collected, and patients consented to receive validated PRO questionnaires at 18-months. The association between IBBR, PMRT, and PROs were investigated using mixed-effects regression models adjusted for clinically-relevant confounders and including a random-effect to account for potential clustering by center. RESULTS: A total of 1163 women consented to receive 18-month questionnaires of whom 730 (63%) completed it. Patients undergoing PMRT (214 patients) reported worse PROs in 3 BREAST-Q domains: satisfaction with breasts [-6.27 points, P = 0.008, 95% confidence interval (CI) (-10.91, -1.63)], satisfaction with outcome [-7.53 points, P = 0.002, CI (-12.20, -2.85)] and physical well-being [-6.55 points, P < 0.001, CI (-9.43, -3.67)]. Overall satisfaction was worse in the PMRT group [OR 0.497, P = 0.002, CI (0.32, 0.77)]. These effects were not ameliorated by mesh use. CONCLUSIONS: PMRT may adversely affect PROs after IBBR irrespective of whether mesh is used. These findings should be discussed with all patients considering IBBR and when indications for PMRT are borderline to enable informed decision-making regarding oncological and reconstructive treatment options. TRIAL REGISTRATION: ISRCTN37664281.

Short-term safety outcomes of mastectomy and immediate prepectoral implant-based breast reconstruction: Pre-BRA prospective multicentre cohort study.

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.

Wire- and magnetic-seed-guided localization of impalpable breast lesions: iBRA-NET localisation study.

BACKGROUND: Wire localization is historically the most common method for guiding excision of non-palpable breast lesions, but there are limitations to the technique. Newer technologies such as magnetic seeds may allow some of these challenges to be overcome. The aim was to compare safety and effectiveness of wire and magnetic seed localization techniques. METHODS: Women undergoing standard wire or magnetic seed localization for non-palpable lesions between August 2018 and August 2020 were recruited prospectively to this IDEAL stage 2a/2b platform cohort study. The primary outcome was effectiveness defined as accurate localization and removal of the index lesion. Secondary endpoints included safety, specimen weight and reoperation rate for positive margins. RESULTS: Data were accrued from 2300 patients in 35 units; 2116 having unifocal, unilateral breast lesion localization. Identification of the index lesion in magnetic-seed-guided (946 patients) and wire-guided excisions (1170 patients) was 99.8 versus 99.1 per cent (P = 0.048). There was no difference in overall complication rate. For a subset of patients having a single lumpectomy only for lesions less than 50 mm (1746 patients), there was no difference in median closest margin (2 mm versus 2 mm, P = 0.342), re-excision rate (12 versus 13 per cent, P = 0.574) and specimen weight in relation to lesion size (0.15 g/mm2versus 0.138 g/mm2, P = 0.453). CONCLUSION: Magnetic seed localization demonstrated similar safety and effectiveness to those of wire localization. This study has established a robust platform for the comparative evaluation of new localization devices.

Breast cancer management pathways during the COVID-19 pandemic: outcomes from the UK 'Alert Level 4' phase of the B-MaP-C study.

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.

Impalpable breast lesion localisation, a logistical challenge: results of the UK iBRA-NET national practice questionnaire.

INTRODUCTION: Breast conserving surgery of impalpable breast lesions requires safe and effective localisation techniques. Wire localisation has traditionally been used, but has limitations. Newer techniques are now being introduced to mitigate this. The iBRA-NET group aims to robustly evaluate these new techniques in well-designed prospective studies. We report the first phase of this evaluation, a survey to establish current practice and service provision of breast localisation techniques in the UK. METHODS: A national practice questionnaire was designed using 'SurveyMonkey®' and was circulated to UK breast surgeons via the Association of Breast Surgery and the Mammary Fold. The questionnaire was live from 6th October 2018 to 6th April 2019. Only one response per unit was requested to reflect the unit's practice. RESULTS: Complete responses were received from 98 breast units across the UK. Wires were the mostly commonly used localisation technique (n = 82) with fewer units using Magseed® (n = 9), Radioguided Occult Lesion Localisation (n = 5) and Radioiodine Seed Localisation (n = 2). There was significant variation in practice and logistics involved. Frequent delays and theatre overruns were reported in 39 and 16 units, respectively. The median satisfaction score of the current technique was 7 out of 10. The main perceived limitation of existing localisation methods was logistics affecting theatre scheduling and the main barrier to introducing a new technique was cost. CONCLUSION: Wires are currently the most commonly used localisation technique but are associated with significant logistical issues. Newer techniques may offer a better solution but will need robust evaluation before they are adopted to ensure safety and efficacy.

Knowledge gaps in oncoplastic breast surgery.

The aims of the Oncoplastic Breast Consortium initiative were to identify important knowledge gaps in the field of oncoplastic breast-conserving surgery and nipple-sparing or skin-sparing mastectomy with immediate breast reconstruction, and to recommend appropriate research strategies to address these gaps. A total of 212 surgeons and 26 patient advocates from 55 countries prioritised the 15 most important knowledge gaps from a list of 38 in two electronic Delphi rounds. An interdisciplinary panel of the Oncoplastic Breast Consortium consisting of 63 stakeholders from 20 countries obtained consensus during an in-person meeting to select seven of these 15 knowledge gaps as research priorities. Three key recommendations emerged from the meeting. First, the effect of oncoplastic breast-conserving surgery on quality of life and the optimal type and timing of reconstruction after nipple-sparing or skin-sparing mastectomy with planned radiotherapy should be addressed by prospective cohort studies at an international level. Second, the role of adjunctive mesh and the positioning of implants during implant-based breast reconstruction should ideally be investigated by randomised controlled trials of pragmatic design. Finally, the BREAST-Q questionnaire is a suitable tool to assess primary outcomes in these studies, but other metrics to measure patient-reported outcomes should be systematically evaluated and quality indicators of surgical morbidity should be further assessed.

Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study.

BACKGROUND: Use of biological or synthetic mesh might improve outcomes of immediate implant-based breast reconstruction-breast reconstruction with implants or expanders at the time of mastectomy-but there is a lack of high-quality evidence to support the safety or effectiveness of the technique. We aimed to establish the short-term safety of immediate implant-based breast reconstruction performed with and without mesh, to inform the feasibility of undertaking a future randomised clinical trial comparing different breast reconstruction techniques. METHODS: In this prospective, multicentre cohort study, we consecutively recruited women aged 16 years or older who had any type of immediate implant-based breast reconstruction for malignancy or risk reduction, with any technique, at 81 participating breast and plastic surgical units in the UK. Data about patient demographics and operative, oncological, and complication details were collected before and after surgery. Outcomes of interest were implant loss (defined as unplanned removal of the expander or implant), infection requiring treatment with antibiotics or surgery, unplanned return to theatre, and unplanned re-admission to hospital for complications of reconstructive surgery, up to 3 months after reconstruction and assessed by clinical review or patient self-report. Follow-up is complete. The study is registered with the ISRCTN Registry, number ISRCTN37664281. FINDINGS: Between Feb 1, 2014, and June 30, 2016, 2108 patients had 2655 mastectomies with immediate implant-based breast reconstruction at 81 units across the UK. 1650 (78%) patients had planned single-stage reconstructions (including 12 patients who had a different technique per breast). 1376 (65%) patients had reconstruction with biological (1133 [54%]) or synthetic (243 [12%]) mesh, 181 (9%) had non-mesh submuscular or subfascial implants, 440 (21%) had dermal sling implants, 42 (2%) had pre-pectoral implants, and 79 (4%) had other or a combination of implants. 3-month outcome data were available for 2081 (99%) patients. Of these patients, 182 (9%, 95% CI 8-10) experienced implant loss, 372 (18%, 16-20) required re-admission to hospital, and 370 (18%, 16-20) required return to theatre for complications within 3 months of their initial surgery. 522 (25%, 95% CI 23-27) patients required treatment for an infection. The rates of all of these complications are higher than those in the National Quality Standards (<5% for re-operation, re-admission, and implant loss, and <10% for infection). INTERPRETATION: Complications after immediate implant-based breast reconstruction are higher than recommended by national standards. A randomised clinical trial is needed to establish the optimal approach to immediate implant-based breast reconstruction. FUNDING: National Institute for Health Research, Association of Breast Surgery, and British Association of Plastic, Reconstructive and Aesthetic Surgeons.

The impact of immediate breast reconstruction on the time to delivery of adjuvant therapy: the iBRA-2 study.

BACKGROUND: Immediate breast reconstruction (IBR) is routinely offered to improve quality-of-life for women requiring mastectomy, but there are concerns that more complex surgery may delay adjuvant oncological treatments and compromise long-term outcomes. High-quality evidence is lacking. The iBRA-2 study aimed to investigate the impact of IBR on time to adjuvant therapy. METHODS: Consecutive women undergoing mastectomy ± IBR for breast cancer July-December, 2016 were included. Patient demographics, operative, oncological and complication data were collected. Time from last definitive cancer surgery to first adjuvant treatment for patients undergoing mastectomy ± IBR were compared and risk factors associated with delays explored. RESULTS: A total of 2540 patients were recruited from 76 centres; 1008 (39.7%) underwent IBR (implant-only [n = 675, 26.6%]; pedicled flaps [n = 105,4.1%] and free-flaps [n = 228, 8.9%]). Complications requiring re-admission or re-operation were significantly more common in patients undergoing IBR than those receiving mastectomy. Adjuvant chemotherapy or radiotherapy was required by 1235 (48.6%) patients. No clinically significant differences were seen in time to adjuvant therapy between patient groups but major complications irrespective of surgery received were significantly associated with treatment delays. CONCLUSIONS: IBR does not result in clinically significant delays to adjuvant therapy, but post-operative complications are associated with treatment delays. Strategies to minimise complications, including careful patient selection, are required to improve outcomes for patients.