BACKGROUND: Germline pathogenic variants mutations) in the BRCA1 and BRCA2 genes cause an increased risk of breast cancer and ovarian cancer. Mainstream cancer genetic testing (MCG) was introduced for breast cancer patients in our unit in 2013. Non-geneticist clinicians have been trained to offer genetic testing during initial treatment planning. We assessed the impact of timely test results on surgical decision-making. METHODS: Women who had undergone mainstream genetic testing for breast cancer between September 2013 and September 2018 were identified from a prospective database. Surgical data were collected retrospectively. RESULTS: 580 eligible women had mainstream genetic testing. For 474 this was their first breast cancer diagnosis. The median age was 46 years (interquartile range (IQR) 38-57). The indications were: age ≤45 years for 233 (49%); triple negative disease for 192 women (40.5%); bilateral breast cancer age <60 for 39 (8%) and other for 72 (14%) women. The median time for test initiation to result was 18 days (IQR 15-21). 302 (64% received results before surgery. 88% of those found to have a BRCA mutation before surgery opted for bilateral mastectomy (compared to 5% with BRCA wild type). An additional 106 patients had a new diagnosis on a background of previous treatment. Of these all with a pathogenic variant chose bilateral mastectomy. CONCLUSION: Timely BRCA gene testing influences surgeons' and patients' choice of surgery. It reassures women with a negative result and allows those with a positive result to take an active decision about the management of their future risk..

INTRODUCTION: The optimal combination of radiotherapy and breast reconstruction has not yet been defined. Post-mastectomy radiotherapy (PMRT) has deleterious effects on breast reconstruction, leading to caution amongst surgeons. Pre-operative radiotherapy (PRT) is a growing area of interest, is demonstrated to be safe, and spares autologous flaps from radiotherapy. This study evaluates the aesthetic outcome of PRT and deep inferior epigastric artery perforator (DIEP) flap reconstruction within the Pre-operative Radiotherapy And Deep Inferior Epigastric artery Perforator (DIEP) flAp (PRADA) cohort. METHODS: PRADA was an observational cohort study designed to evaluate the feasibility and safety of PRT for women undergoing neoadjuvant chemotherapy and DIEP reconstruction. Panel evaluation of 3D surface images (3D-SIs) and patient-reported outcome measures (BREAST-Q) for a subset of women in the study were compared with those of a DIEP-PMRT cohort who had undergone DIEP reconstruction and PMRT. RESULTS: Seventeen out of 33 women from the PRADA study participated in this planned substudy. Twenty-eight women formed the DIEP-PMRT cohort (median follow-up 23 months). The median (inter-quartile range [IQR]) 'satisfaction with breasts' score at 12 months for the PRADA cohort was significantly better than the DIEP-PMRT cohort (77 [72-87] versus 64 [54-71], respectively), p=0.01). Median [IQR] panel evaluation (5-point scale) was also significantly better for the PRADA cohort than for the DIEP-PMRT cohort (4.3 [3.9-4.6] versus 3.6 [2.8-4] p=0.003). CONCLUSIONS: Aesthetic outcome for the PRADA cohort was reported to be 'good' or 'excellent' in 93% of cases using a bespoke panel assessment with robust methodology. Patient satisfaction at one year is encouraging and superior to DIEP-PMRT at 23 months. Switching surgery-radiotherapy sequencing leads to similar breast aesthetic outcomes and warrants further large-scale, multi-centre evaluation in a randomised trial..

BACKGROUND: Breast Cancer incidence in the UK is estimated to rise to 71,000 per year by 2035. Preventative strategies could significantly reduce this. Preventative therapy reduces women's risk of oestrogen receptor positive breast cancer, but uptake remains low. Having established a preventative therapy clinic as part of a wider breast cancer prevention project, we explored qualitative data to inform future preventative efforts. METHOD: Women aged 30 to 60 who had benign diagnoses at a symptomatic breast clinic or were under mammographic surveillance in the moderate risk family history clinic were invited to participate in the study. Those who expressed an interest and completed an initial questionnaire had their breast cancer risk calculated using the IBIS risk calculator. Those at increased risk were invited to a consultation about preventative therapy. RESULTS: 182 women were identified as increased risk (≥ 17% lifetime or ≥ 3% 10-year risk NICE guidelines: Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer, 20131) of whom 91 women (50%) would not have been identified by family history criteria alone. 96% attended a risk/prevention consultation and all eligible women accepted screening mammography but only 14 (8%) women requested a preventative therapy prescription during the duration of the study. Reluctance to take medication and inconvenient time of life were common reasons for declining preventative therapy. Despite this, the majority were grateful for breast cancer risk and prevention information. CONCLUSIONS: Women at increased risk of breast cancer accept additional screening but are reluctant to take preventative therapy. This suggests that stratified screening methods using risk calculations would have high uptake. Raising awareness of preventative therapy is important and the breast cancer community has yet to find the optimum timing and formula for discussing it and must accept women's informed preferences above artificial targets. REGISTRATION NUMBERS: The PIONEER study was granted Health Research Authority (HRA) ethical approval by the Westminster Ethics Committee. IRAS project ID 265619, ClinicalTrials.gov Identifier: NCT04574063. Recruitment began in September 2020 and was completed in October 2021..

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BACKGROUND: Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. However, evidence for this treatment sequence is sparse. We aimed to explore the feasibility of preoperative radiotherapy followed by skin-sparing mastectomy and deep inferior epigastric perforator (DIEP) flap reconstruction in patients with breast cancer requiring mastectomy. METHODS: We conducted a prospective, non-randomised, feasibility study at two National Health Service trusts in the UK. Eligible patients were women aged older than 18 years with a laboratory diagnosis of primary breast cancer requiring mastectomy and post-mastectomy radiotherapy, who were suitable for DIEP flap reconstruction. Preoperative radiotherapy started 3-4 weeks after neoadjuvant chemotherapy and was delivered to the breast, plus regional nodes as required, at 40 Gy in 15 fractions (over 3 weeks) or 42·72 Gy in 16 fractions (over 3·2 weeks). Adverse skin radiation toxicity was assessed preoperatively using the Radiation Therapy Oncology Group toxicity grading system. Skin-sparing mastectomy and DIEP flap reconstruction were planned for 2-6 weeks after completion of preoperative radiotherapy. The primary endpoint was the proportion of open breast wounds greater than 1 cm width requiring a dressing at 4 weeks after surgery, assessed in all participants. This study is registered with ClinicalTrials.gov, NCT02771938, and is closed to recruitment. FINDINGS: Between Jan 25, 2016, and Dec 11, 2017, 33 patients were enrolled. At 4 weeks after surgery, four (12·1%, 95% CI 3·4-28·2) of 33 patients had an open breast wound greater than 1 cm. One (3%) patient had confluent moist desquamation (grade 3). There were no serious treatment-related adverse events and no treatment-related deaths. INTERPRETATION: Preoperative radiotherapy followed by skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically safe, with rates of breast open wounds similar to those reported with post-mastectomy radiotherapy. A randomised trial comparing preoperative radiotherapy with post-mastectomy radiotherapy is required to precisely determine and compare surgical, oncological, and breast reconstruction outcomes, including quality of life. FUNDING: Cancer Research UK, National Institute for Health Research..

Incidence of bilateral risk-reducing mastectomies (RRMs) is increasing. The aim of this study was to compare satisfaction, aesthetic and oncological outcomes in women undergoing RRM with implant-based reconstruction comparing nipple-sparing mastectomy (NSM) with skin-sparing mastectomy (SSM) (sacrificing the nipple +/− nipple reconstruction). Women who had undergone bilateral RRM between 1997 and 2016 were invited. Aesthetic outcome and nipple symmetry were evaluated using standardized anthropometric measurements. The oncological outcome was assessed at last documented follow up. Ninety-three women (186 breasts) participated, 60 (64.5%) had NSM, 33 (35.5%) SSM. Median time between surgery and participation was 98.4 months (IQR: 61.7−133.9). Of the women, 23/33 (69.7%) who had SSM underwent nipple reconstruction. Nipple projection was shorter in the reconstructed SSM group than the maintained NSM group (p < 0.001). There was no significant difference in overall symmetry (p = 0.670), satisfaction regarding nipple preservation (p = 0.257) or overall nipple satisfaction (p = 0.074). There were no diagnoses of breast cancer at a median follow up of 129 months (IQR: 65−160.6). Women who undergo nipple-sparing RRM maintain long-term nipple symmetry. Nipple projection was less maintained after nipple reconstruction. Although satisfaction with the nipples was higher in the NSM group, this did not reach statistical significance. No breast cancers developed after RRM with long-term follow up..

Background Guide-wire localisation remains the most commonly used technique for localisation of impalpable breast lesions in the UK. One alternative is magnetic seed localisation. We aimed to investigate patient and clinician satisfaction in two consecutive cohorts, describe re-excision and positive margin rates, and explore reasons for positive margins and the implications for localisation techniques.Methods A single-institution prospective service evaluation of two cohorts of consecutive cases of wire and then Magseed localisation was carried out. Data were collected on patient and clinician satisfaction, clinico-pathological findings, and causes of involved margins. T tests were used to compare continuous variables and Chi-squared test for satisfaction outcomes.Results 168 consecutive cases used wire-guided localisation (WGL) and 128 subsequent cases used Magseeds. Patients reported less anxiety between localisation and surgery in the Magseed group, and clinicians reported greater ease of use of Magseeds. There were no differences in lesion size, surgical complexity, or re-excision rate between the groups. In a subset of patients receiving standard wide local excision (i.e., excluding mammoplasties), the impact on margin involvement was investigated. There was no significant difference in radiological under-sizing or accuracy of localisation. However, specimen weight and eccentricity of the lesion were statistically significantly lower in the Magseed group. Despite this, re-excision rates were not significantly different (p = 0.4).Conclusions This is the first large study of satisfaction with localisation and showed clinician preference for Magseed and a reduction in patient anxiety. It also demonstrated similar positive margin rates despite smaller specimen weights in the Magseed group. Magnetic seed localisation offers an acceptable clinical alternative to guide wire localisation. The impact on local service provision should also be considered..

INTRODUCTION: Over half of women with surgically managed breast cancer in the UK undergo breast-conserving treatment (BCT). While photographs are shown prior to reconstructive surgery or complex oncoplastic procedures, standard practice prior to breast conservation is to simply describe the likely aesthetic changes. Patients have expressed the desire for more personalized information about likely appearance after surgery. The hypothesis was that viewing a three-dimensional (3D) simulation improves patients' confidence in knowing their likely aesthetic outcome after surgery. METHODS: A randomized, controlled trial of 117 women planning unilateral BCT was undertaken. The randomization was three-way: standard of care (verbal description alone, control group), viewing two-dimensional (2D) photographs, or viewing a 3D simulation before surgery. The primary endpoint was the comparison between groups' median answer on a visual analogue scale (VAS) for the question administered before surgery: 'How confident are you that you know how your breasts are likely to look after treatment?' RESULTS: The median VAS in the control group was 5.2 (i.q.r. 2.6-7.8); 8.0 (i.q.r. 5.7-8.7) for 2D photography, and 8.9 (i.q.r. 8.2-9.5) for 3D simulation. There was a significant difference between groups (P < 0.010) with post-hoc pairwise comparisons demonstrating a statistically significant difference between 3D simulation and both standard care and viewing 2D photographs (P < 0.010 and P = 0.012, respectively). CONCLUSION: This RCT has demonstrated that women who viewed an individualized 3D simulation of likely aesthetic outcome for BCT were more confident going into surgery than those who received standard care or who were shown 2D photographs of other women. The impact on longer-term satisfaction with outcome remains to be determined.Registration number: NCT03250260 (http://www.clinicaltrials.gov)..

INTRODUCTION:Evaluation of aesthetics after breast reconstruction is challenging. In the absence of an objective measurement, panel assessment is widely adopted. Heterogeneity of scales and poor internal consistency make comparison difficult. Development and validation of an expert panel scale using a Delphi consensus process is described. It was designed specifically for use as the gold standard for development of an objective evaluation tool using 3-Dimensional Surface Imaging (3D-SI). MATERIALS AND METHODS:20 items relating to aesthetic assessment were identified for consideration in the Delphi consensus process. Items were selected for inclusion in the definitive panel scale by iterative rounds of voting according to importance, consensus discussion, and a final vote. The Delphi-derived scale was tested on a clinical research series for intra- and inter-panellist, and intra-panel reliability, and correlation with Patient Reported Outcome Measures (PROMs). RESULTS:61 surgeons participated in the Delphi process. Oncoplastic and plastic surgeons were represented. The Delphi-derived scale included symmetry, volume, shape, position of breast mound, nipple position, and a global score. Intra-panellist reliability ranged from poor to almost perfect (wκ<0to0.86), inter-rater reliability was fair (ICC range 0.4-0.5) for individual items and good (ICC0.6) for the global score, intra-panel reliability was moderate to substantial (wκ0.4-0.7), and correlation with PROMs was moderate (r = 0.5p < 0.01). CONCLUSIONS:The Delphi-derived panel evaluation is at least as good as other scales in the literature and has been developed specifically to provide expert evaluation of aesthetics after breast reconstruction. The logistical constraints of panel assessment remain, reinforcing the need to develop an objective evaluation method..

Background Two-thirds of patients with early breast cancer undergo breast-conserving treatment (BCT). Aesthetic outcome is important and has long term implications for psychosocial wellbeing. The aesthetic goal of BCT is symmetry for which there is no gold-standard measure. Panel scoring is the most widely adopted assessment but has well-described limitations. This paper describes a model to objectively report aesthetic outcome using measures derived from 3-dimensional surface images (3D-SI).Method Objective measures and panel assessment were undertaken independently for 3D-SI of women who underwent BCT 1-5 years previously. Univariate analysis was used to test for association between measures and panel score. A forward stepwise multiple linear regression model was fitted to identify 3D measurements that jointly predicted the mean panel score. The fitted model coefficients were used to predict mean panel scores for an independent validation set then compared to the mean observed panel score.Results Very good intra-panel reliability was observed for the training and validation sets (wκ = 0.87, wκ = 0.84). Six 3D-measures were used in the multivariate model. There was a good correlation between the predicted and mean observed panel score in the training (n = 190) and validation (n = 100) sets (r = 0.68, r = 0.65). The 3D model tended to predict scores towards the median. The model was calibrated which improved the distribution of predicted scores.Conclusion A six-variable objective aesthetic outcome model for BCT has been described and validated. This can predict and could replace panel assessment, facilitating the independent and unbiased evaluation of aesthetic outcome to communicate and compare results, benchmark practice, and raise standards..

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Background The use of nipple-sparing mastectomy (NSM) is increasing, despite unproven oncological safety in the therapeutic setting. The aim of this systematic review was to determine the safety and efficacy of NSM compared with skin-sparing mastectomy (SSM).Methods A literature search of all original studies including RCTs, cohort studies and case-control studies comparing women undergoing therapeutic NSM or SSM for breast cancer was undertaken. Primary outcomes were oncological outcomes; secondary outcomes were clinical, aesthetic, patient-reported and quality-of-life outcomes. Data analysis was undertaken to explore the relationship between NSM and SSM, and preselected outcomes. Heterogeneity was assessed using the Cochrane tests.Results A total of 690 articles were identified, of which 14 were included. There was no statistically significant difference in 5-year disease-free survival and mortality for NSM and SSM groups, where data were available. Local recurrence rates were also similar for NSM and SSM (3·9 versus 3·3 per cent respectively; P  = 0·45). NSM had a partial or complete nipple necrosis rate of 15·0 per cent, and a higher complication rate than SSM (22·6 versus 14·0 per cent respectively). The higher overall complication rate was due to the rate of nipple necrosis in the NSM group (15·0 per cent).Conclusion In carefully selected cases, NSM is a viable choice for women with breast cancer who need to have a mastectomy. More research is needed to help further refine which surgical approaches to NSM optimize outcomes..

Purpose: The most significant prognostic factor in early breast cancer is lymph node involvement. This stage between localized and systemic disease is key to understanding breast cancer progression; however, our knowledge of the evolution of lymph node malignant invasion remains limited, as most currently available data are derived from primary tumors.Experimental Design: In 11 patients with treatment-naïve node-positive early breast cancer without clinical evidence of distant metastasis, we investigated lymph node evolution using spatial multiregion sequencing (n = 78 samples) of primary and lymph node deposits and genomic profiling of matched longitudinal circulating tumor DNA (ctDNA).Results: Linear evolution from primary to lymph node was rare (1/11), whereas the majority of cases displayed either early divergence between primary and nodes (4/11) or no detectable divergence (6/11), where both primary and nodal cells belonged to a single recent expansion of a metastatic clone. Divergence of metastatic subclones was driven in part by APOBEC. Longitudinal ctDNA samples from 2 of 7 subjects with evaluable plasma taken perioperatively reflected the two major evolutionary patterns and demonstrate that private mutations can be detected even from early metastatic nodal deposits. Moreover, node removal resulted in disappearance of private lymph node mutations in ctDNA.Conclusions: This study sheds new light on a crucial evolutionary step in the natural history of breast cancer, demonstrating early establishment of axillary lymph node metastasis in a substantial proportion of patients. Clin Cancer Res; 24(19); 4763-70. ©2018 AACR..

PURPOSE: Three-dimensional surface imaging (3D-SI) of the breasts enables the measurement of breast volume and shape symmetry. If these measurements were sufficiently accurate and repeatable, they could be used in planning oncological breast surgery and as an objective measure of aesthetic outcome. The aim of this study was to validate the measurements of breast volume and symmetry provided by the Vectra XT imaging system. METHODS: To validate measurements, breast phantom models of true volume between 100 and 1000 cm3 were constructed and varying amounts removed to mimic breast tissue 'resections'. The volumes of the phantoms were measured using 3D-SI by two observers and compared to a gold standard. For intra-observer repeatability and inter-observer reproducibility in vivo, 16 patients who had undergone oncological breast surgery had breast volume and symmetry measured three times by two observers. RESULTS: A mean relative difference of 2.17 and 2.28% for observer 1 and 2 respectively was seen in the phantom measurements compared to the gold standard (n = 45, Bland Altman agreement). Intra-observer variation over ten repeated measurements demonstrated mean coefficients of variation (CV) of 0.58 and 0.49%, respectively. The inter-observer variation demonstrated a mean relative difference of 0.11% between the two observers. In patients, intra-observer variation over three repeated volume measurements for each observer was 3.9 and 3.8% (mean CV); the mean relative difference between observers was 5.78%. For three repeated shape symmetry measurements using RMS projection difference between the two breasts, the intra-observer variations were 8 and 14% (mean CV), the mean relative difference between observers was 0.43 mm for average symmetry values that ranged from about 3.5 to 15.5 mm. CONCLUSION: This first validation of breast volume and shape symmetry measurements using the Vectra XT 3D-SI system suggests that these measurements have the potential to assist in pre-operative planning and also as a measure of aesthetic outcome..

Nipple-sparing mastectomy is a valuable addition to the options available for women at high risk of developing breast cancer. In this review, we summarize current knowledge about the high-risk genes, BRCA1 , BRCA2 and TP53 and the associated guidelines with regard to risk-reducing surgery. We consider other genetic risks and high-risk lesions. We discuss the literature on bilateral mastectomy for breast cancer risk-reduction, and the results of nipple-sparing mastectomy in particular. Finally, we report on patient satisfaction with these procedures and the impact that nipple-sparing mastectomy may have on women at high-risk of breast cancer..

Background The authors investigated aesthetic outcome and patient satisfaction in women who have undergone deep inferior epigastric artery perforator (DIEP) flap reconstruction in the setting of postmastectomy radiotherapy. Patients who underwent DIEP flap reconstruction without postmastectomy radiotherapy were the control group.Methods Participants who had undergone DIEP flap reconstruction between September 1, 2009, and September 1, 2014, were recruited, answered the BREAST-Q, and underwent three-dimensional surface-imaging. A panel assessed the aesthetic outcome by reviewing these images.Results One hundred sixty-seven women participated. Eighty women (48 percent) underwent immediate DIEP flap reconstruction and no postmastectomy radiotherapy; 28 (17 percent) underwent immediate DIEP flap reconstruction with postmastectomy radiotherapy; 38 (23 percent) underwent simple mastectomy, postmastectomy radiotherapy, and DIEP flap reconstruction; and 21 (13 percent) underwent mastectomy with temporizing implant, postmastectomy radiotherapy, and DIEP flap reconstruction. Median satisfaction scores were significantly different among the groups (p < 0.05). Post hoc comparison demonstrated that women who had an immediate DIEP flap reconstruction were significantly less satisfied if they had postmastectomy radiotherapy. In women requiring radiotherapy, those undergoing delayed reconstruction after a simple mastectomy were most satisfied, but there was no significant difference between the immediate DIEP flap and temporizing implant groups. Median panel scores differed among groups, being significantly higher if the immediate reconstruction was not subjected to radiotherapy. There was no significant difference in panel assessment among the three groups of women who had received radiotherapy.Conclusions Patients who avoid having their immediate DIEP flap reconstruction irradiated are more satisfied and have better aesthetic outcome than those who undergo postmastectomy radiotherapy. In women requiring radiotherapy and who wish to have an immediate or "delayed-immediate" reconstruction, there were no significant differences in panel or patient satisfaction. Therefore, immediate DIEP flap reconstruction or mastectomy with temporizing implant then DIEP flap surgery are acceptable treatment pathways in the context of post-mastectomy radiotherapy..

PURPOSE: To establish whether objective measurements of symmetry of volume and shape using three-dimensional surface imaging (3D-SI) can be used as surrogate markers of aesthetic outcome in patients who have undergone breast conserving therapy (BCT). METHODS: Women who had undergone unilateral BCT in the preceding 1-6 years were invited to participate. Participants completed a satisfaction questionnaire (BREAST-Q) and underwent 3D-SI. Volume and surface symmetry were measured on the images. Assessment of aesthetic outcome was undertaken by a panel of clinicians. The Kruskal-Wallis test was used to assess the relationship between volume and shape symmetry measurements with the panel score. Spearman's rho correlations were used to assess the relationship between the measurements and patient satisfaction. RESULTS: 200 women participated. Median volume symmetry was 87% (IQR 78-93) and shape symmetry was 5.9 mm (IQR 4.2-8.0). The participants were grouped according to panel assessment of aesthetic outcome (poor, fair, good, excellent) and the median volume and shape symmetry was calculated for each group. Volume symmetry significantly differed between the groups. Post hoc pairwise comparisons demonstrated that these differences existed between panel scores of fair versus good and good versus excellent. Median shape symmetry also differed according to patient panel groups with four significant pairwise comparisons between poor versus good, poor versus excellent, fair versus good and fair versus excellent. There was a significant but weak correlation of both volume symmetry and surface asymmetry with BREAST-Q scores (correlation coefficients 0.187 and -0.229, respectively). CONCLUSION: Breast volume and shape symmetry are both associated with panel assessment scores and patient satisfaction. The objective volume and shape symmetry measures were strongly associated with panel assessment scores, such that a 3D-SI tool could replace panel assessment as a faster and more objective method of evaluating aesthetic outcomes..

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Introduction Bilateral mammoplasty (BM) can optimise oncological safety and aesthetic outcomes in women with large or ptotic breasts whose tumour to breast volume ratio or tumour location pose a challenge to standard breast-conserving therapy (BCT) and for whom mastectomy (with or without reconstruction) may be the only alternative.Methods We undertook a comprehensive analysis of surgical outcomes (complications according to the Clavien Dindo classification), acute radiation morbidity (Radiation Therapy Oncology Group classification), oncological outcomes, and patient satisfaction (BREAST-Q questionnaire) in women who underwent BM for breast cancer (BC) from June 2009-November 2014.Results 168 women were included. Median age was 55 years (range:33-84) and median tumour size at imaging 35 mm (range:0-170). Median specimen weight was 242 g (range 39-1824). The wise pattern technique was used in 87.5% of procedures. At least one complication occurred in 68 (40.5%) women, mostly Clavien Dindo grade 1. Grade 3 complications were infrequent (8.9%) but occurred mainly on the therapeutic mammoplasty (TM) side (p < 0.05). Complications were associated with higher BMI, specimen weight and longer time to radiotherapy (p < 0.05). Median follow-up was 37 months (range: 13-77). Local recurrence occurred in 3 (1.8%), distant metastases in 5 (3.0%), and 10 (6.0%) women have died. The median score for 'satisfaction with breasts' was 77 (range: 0-100).Conclusions This study provides concurrent data on surgical, oncological and patient-reported outcomes. It offers evidence that BM is an effective treatment for breast cancer in large- or ptotic-breasted women..

Introduction Oncoplastic breast surgery is used to extend the role of breast-conserving surgery (BCS) to women with an unfavourable tumour to breast volume ratio. However, large-breasted women with a relatively small breast cancer may be offered bilateral reduction mammoplasty (BRM) despite being suitable for standard BCS as the more complex surgery may have advantages in terms of patient satisfaction and reduced adverse effects of radiotherapy.Patient and methods This retrospective study evaluated surgical and patient-reported outcome measures (PROMs) in large-breasted women with early (<3 cm) breast cancer, who have undergone unilateral standard BCS or BRM.Results This series included 157 women, 87 in the unilateral BCS group and 70 in the BRM group. Median age was 60.2 years (range: 33-83.9). Median follow-up was 36 months (range: 9.8-76). Tumour size, rates of axillary dissection, adjuvant chemotherapy and tumour bed irradiation boost were significantly greater in the BRM group (p < 0.05). The surgical complication rate was not significantly different (43.7% vs. 34.3%, p = 0.253). Re-excision rates were higher in the standard BCS group (p < 0.05). Time to chemotherapy was similar, but time to radiotherapy was longer after BRM surgery (p = 0.025). Despite worse prognostic factors, more complex surgery and more aggressive adjuvant treatment, patients report better satisfaction and physical functioning and fewer adverse effects of radiotherapy after BRM than standard unilateral BCS. This difference was not statistically different in this small study (p > 0.05).Conclusion Limitations of this study mean it can only be regarded as hypothesis-generating. Nonetheless, the trends merit a prospective study to investigate the optimal management of smaller breast cancers in larger-breasted women..

Introduction Ultrasound (US) is the imaging modality of choice for staging the axilla prior to surgery in patients with breast cancer (BC). High pathological complete response rates in the axilla after NACT mean a more conservative approach to surgery can be considered. Radiological re-staging is important in this decision making. After the presentation of results from ACOSOG Z1071 in December 2012, formal ultrasound re-assessment of the axilla after primary therapy was specifically requested in our institution. We report on the accuracy of axillary US (aUS) for identifying residual axillary disease post-NACT.Methods Data were collected on patients who had proven axillary disease prior to NACT and underwent axillary lymph node dissection after NACT between January 2013 and December 2015. Post-chemotherapy aUS reports and axillary pathology reports were classified as positive or negative for abnormal lymph nodes and for residual disease (cCR and pCR respectively).Results The sensitivity and specificity of aUS was 71% and 88% respectively. The negative predictive value (NPV) was 83%. The false negative rate was 29%.Conclusions Axillary ultrasound provides clinically useful information post-NACT, which will guide surgical decision-making. Patients with aUS-negative axillae are likely to have a lower false negative rate of SLNB after NACT (Boughey et al.). However, aUS does not replace the need to identify and biopsy the nodes which were proven to be positive prior to NACT..

PURPOSE: The most recently developed module of the BREAST-Q, a validated patient outcome measure, is for patients who have undergone breast-conserving therapy (BCT) for cancer. This aim of this study was to assess patient satisfaction and quality of life after BCT using BREAST-Q, investigate clinical risk factors for lower satisfaction and explore the relationship between patient satisfaction with the appearance of their breasts and the other domains of the BREAST-Q. METHODS: Women who had undergone unilateral BCT in the preceding 1-6 years were invited to participate at the time of their annual surveillance mammogram. Clinicopathological data were collected from an electronic database. Linear regression was used to evaluate risk factors for lower satisfaction. Spearman's rho correlation coefficients were calculated to evaluate the relationship between domains. RESULTS: 200 women completed the questionnaire. Mean age was 60 years (SD 11.1). Time from surgery was 35.5 months (SD 17.8). Median score for 'Satisfaction with breasts' was 68 (interquartile range 55-80). Lowest scores were for 'sexual wellbeing' (57, IQR 45-66). On multivariate analysis, BMI at the time of surgery (p = 0.002), delayed wound healing (p = 0.001) and axillary surgery (p = 0.003) were independent risk factors for lower satisfaction. There was significant correlation between 'Satisfaction with breasts' and all other BREAST-Q domains. CONCLUSION: High BMI, delayed wound healing and axillary surgery are risk factors for lower patient satisfaction. This first publication reporting the whole dataset for the BREAST-Q BCT will serve as a benchmark for future studies of patient satisfaction following BCT..

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Introduction Breast cancer has a lifetime incidence of one in eight women. Over the past three decades there has been a move towards breast conservation and a focus on aesthetic outcomes while maintaining oncological safety. For some patients, mastectomy is the preferred option. There is growing interest in the potential use of nipple sparing mastectomy (NSM). However, oncological safety remains unproven, and the benefits and indications have not been clearly identified. The objective of this systematic review will be to determine the safety and efficacy of NSM as compared with skin sparing mastectomy (SSM).Methods and analysis All original comparative studies including; randomised controlled trials, cohort studies and case-control studies involving women undergoing either NSM or SSM for breast cancer will be included. Outcomes are primary-relating to oncological outcomes and secondary-relating to clinical, aesthetic, patient reported and quality of life outcomes. A comprehensive electronic literature search, designed by a search specialist, will be undertaken. Grey literature searches will also be conducted. Eligibility assessment will occur in two stages; title and abstract screening and then full text assessment. Each step will be conducted by two trained teams acting independently. Data will then be extracted and stored in a database with standardised extraction fields to facilitate easy and consistent data entry. Data analysis will be undertaken to explore the relationship between NSM or SSM and preselected outcomes, heterogeneity will be assessed using the Cochrane tests.Ethics and dissemination This systematic review requires no ethical approval. It will be published in a peer-reviewed journal. It will also be presented at national and international conferences. Updates of the review will be conducted to inform and guide healthcare practice and policy..

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Abstract Background There is a limited evidence base to guide surgeons on the ideal thickness of skin flaps during mastectomy. Here the literature relevant to optimizing mastectomy skin flap thickness is reviewed, including anatomical studies, oncological considerations, factors affecting viability, and the impact of surgical technique and adjuvant therapies. Methods A MEDLINE search was performed using the search terms ‘mastectomy’ and ‘skin flap’ or ‘flap thickness’. Titles and abstracts from peer-reviewed publications were screened for relevance. Results A subcutaneous layer of variable thickness that contains minimal breast epithelium lies between the dermis and breast tissue. The thickness of this layer may vary within and between breasts, and does not appear to be associated with obesity or age. The existence of a distinct layer of superficial fascia in the breast remains controversial and may be present in only up to 56 per cent of patients. When present, it may not be visible macroscopically, and can contain islands of breast tissue. As skin flap necrosis occurs in approximately 5 per cent of patients, a balance must be sought between removing all breast tissue at mastectomy and leaving reliably viable skin flaps. Conclusion The variable and unpredictable thickness of the breast subcutaneous layer means that a single specific universal thickness for mastectomy skin flaps cannot be recommended. It may be that the plane between the subdermal fat and breast parenchyma is a reasonable guide for mastectomy flap thickness, but this may not always correspond to a subcutaneous fascial layer. .

The rate of surgical site infection (SSI) after breast surgery is higher than expected for a 'clean procedure'. There is currently no consensus on the use of antibiotics, and as a result there is variation in use. An infection may compromise cosmesis and delay the start of adjuvant therapy. This research highlight reviews a recent paper by Gulluoglu and colleagues investigating the use of antibiotics in overweight and obese patients undergoing breast cancer surgery and also reviews the current literature on this important topic..

Abstract Introduction Doctors who are diagnosed with breast cancer make up a small but unique subset of women owing to their medical knowledge. Anecdote suggests that doctors with breast cancer are more likely to opt for mastectomy than non-medically qualified patients. The primary aim of this study was to compare mastectomy rates in medically-qualified doctors with degree-educated controls with breast cancer. Methods Research ethics approval was obtained. Patients diagnosed with breast cancer between 1/1/2006 and 31/12/2011 and who had signed a generic research consent form were included in this observational study. Every patient was screened by occupation independently by 2 investigators to identify medically-qualified doctors and suitable (degree-educated) controls such as teachers, lawyers etc. Those with a medical background (e.g.nurse, physiotherapist etc) but not a medical doctor were excluded. Further exclusions were necessary if patients who were reviewed for a second opinion, reconstruction only or radiotherapy only or were male, surgery was not performed, BRCA positivity (might opt for bilateral mastectomy), unusual histology (e.g. lymphoma, sarcoma), recurrence or had a past history of contralateral breast cancer. Doctors and controls were compared by age, tumour characteristics and treatments using Student's t test for continuous variables and Fisher's exact test for categorical variables. Results: In total 8623 patients were reviewed and/or treated for breast cancer of whom 5215 had signed the generic research consent form. Overall 607 were either doctors or appropriate occupation controls. After exclusions 473 patients were eligible to be included in the analysis. Of these: 51 were medically-qualified doctors and 422 were degree-educated (controls). Comparison of tumour characteristics and treatment between doctors and controls DoctorsControlspNumber51422 Mean age (years)53.350.80.11Mean total tumour size (mm)32.231.60.89     Number (%)Number (%)pDCIS alone10(20)53 (13)0.18Node positive16 (31)157 (37)0.44ER positive45 (88)337 (80)0.18HER2 positive12 (24)113 (27)0.73    Neoadjuvant chemotherapy6 (12)58 (14)0.83Adjuvant chemotherapy14 (27)154 (36)0.21    mastectomy17 (33)145 (34)1.00Immediate reconstruction9 (53)65 (45)0.61Post mastectomy radiotherapy5 (29)68 (47)0.20Comparison of age, tumour characteristics, mastectomy, chemotherapy and post mastectomy radiotherapy rates between doctors and the control group There was no statistical difference in age and tumour characteristics between the doctors with breast cancer and the control group. There was no statistical difference in chemotherapy rate, mastectomy rate, or uptake of immediate breast reconstruction or post-mastectomy radiotherapy in mastectomy patients between the doctors with breast cancer and the control group. Conclusion Doctors in this study were not statistically more likely to undergo mastectomy than controls. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P1-09-18..

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Abstract Introduction: Intra-operative assessment of sentinel nodes (SLNs) allows immediate completion axillary dissection (cALND) in breast cancer patients. Molecular assessment such as one-step nucleic acid amplication (OSNA) promises greater sensitivity and provides a more accurate quantitative assessment than traditional methods. Our unit policy is to proceed to cALND in patients with macrometastases but not for micrometastases. However, evidence of upstaging has led us to seek to raise the threshold for proceeding to cALND. The CK19 mRNA copy number is an expression of the metastatic burden in the SLN and may be related to the presence of additional disease in the cALND. Since the original copy number threshold between micro (250–5000 copies/microliter) and macrometastasis (&gt;5000 copies/microliter) was based on few patients and serial pathological sections, we investigated the mRNA copy number in patients with and without additional disease in the cALND. Methods: All patients in our unit undergo pre-operative axillary ultrasound with fine needle aspiration cytology of any suspicious nodes. Those with malignant cytology proceed directly to ALND. Radiologically and cytologically node negative patients undergo sentinel lymph node biopsy (SLNB) and OSNA. Electronic records of consecutive patients with invasive breast cancer undergoing SLNB with OSNA from August 2011 to March 2012 were retrospectively reviewed. Two parameters of mRNA copy number were examined: Copy number of the highest copy number SLN and the summed copy numbers of all positive SLNs. Their relationship to the presence of further disease in the axilla was examined using Student's t test. Results: Of 201 SLNBs, 45 (22%) had macrometastasis-positive OSNA and therefore underwent cALND (1 patient declined). Twenty patients (45%) had no further positive nodes (a negative cALND) with a total axillary metastatic burden of 1–2 in 11–27 nodes. Twenty four (55%) showed further disease (a positive cALND) with a burden of 2–20 in 9–30 nodes, including the SLNs. There was no significant difference in tumour size or grade between patients with additional positive nodes in the cALND compared with those with no further disease. There was no significant difference in the copy number of the highest copy number positive SLN (p = 0.44) or in the summed copy number of all positive SLNs (p = 0.36) between the cALND positive and negative groups. Conclusion: OSNA CK19 mRNA copy number does not correlate with the cALND metastatic burden. Therefore, raising the copy number threshold may be too simplistic as a method to better select patients with high probability of a positive cALND. A predictive model will be derived based on multivariate analysis of the larger patient population (&gt;400 patients) that will have undergone SLNB with OSNA by the time of SABCS. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-01-11..

Abstract Introduction: Intra-operative assessment (IOA) of the axillary sentinel lymph node (SLN) allows immediate completion axillary lymph node dissection (cALND) for a positive SLN. One-step nucleic acid amplification assay (OSNA, (Sysmex)), a molecular technique, is very sensitive and may upstage the axilla compared with other forms of intra-operative assessment and with formal, paraffin-embedded haematoxylin and eosin (H&E) histopathology. This would result in an increased cALND rate at a time when efforts are being made to reduce unnecessary axillary surgery in line with the Z0011 trial (Giuliano et al. 2011). This study compares node positive rates before and after two changes in practice: the introduction of OSNA and the unit policy to perform cALND for macrometastatic SLN disease only. Methods: All patients in our unit undergo pre-operative axillary ultrasound with fine needle aspiration cytology of any suspicious nodes. Those with malignant cytology proceed directly to ALND. Radiologically and cytologically node negative patients undergo SLNB. Consecutive electronic records were examined for all SLNB procedures in two groups: Pre-OSNA from June 2006 to December 2010 and OSNA from August 2011 to March 2012. Pre-OSNA, patients were offered cALND for micro-or macroscopic SLN disease identified by H&E histology. Following Z0011, patients in the OSNA group proceeded to cALND for SLN macrometastases but not for micrometastases. The chi-squared test was used to compare results between the two groups. Results: The groups were similar in terms of age, tumour size, grade and receptor status. Sentinel node and cALND results are shown in table 1. In summary, testing by OSNA resulted in a higher node positive rate and a greater proportion reported with micrometastases (40% compared with 23% pre-OSNA). The OSNA macrometastasis rate was equal to the pre-OSNA overall node positive rate (22%). Among patients proceeding to cALND (all node-positive pre-OSNA patients and OSNA patients with macrometastases) there was no significant difference in the proportion with additional positive nodes in the cALND or the proportion with a total of four or more positive nodes. Conclusion: The introduction of OSNA has increased the proportion of patients identified as node positive, and has increased the proportion reported to have macrometastasis. Simultaneously, the decision not to perform cALND for patients with micrometastasis was intended to limit the additional surgery performed in the SLNB group as a whole. However, since this decision was based on data from studies using H&E assessment, we should look for ways to raise the threshold for cALND such that it includes only the patients at the highest risk of axillary recurrence. Reference Giuliano AE et al. JAMA 2011; 305(6): 569–75. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-01-10..

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Although there is scant evidence to support multidisciplinary meetings in any cancer specialty, they are now regarded as best practice. We believe the oncoplastic multidisciplinary meeting plays a similarly important role, consolidating oncoplastic multidisciplinary working and allowing transparent decision making, standardisation of care and recording of results. This may drive oncoplastic surgery to an evidence-based position from which oncoplastic excellence can be achieved. .

INTRODUCTION Immediate breast reconstruction after mastectomy has known psychological and financial advantages but it is difficult to compare the outcome of various methods of reconstruction. Re-operation rates are an objective measure of surgical intervention required to attain and maintain acceptable cosmesis. PATIENTS AND METHODS A series of 95 patients (110 immediate reconstructions) was analysed for number of re-operations required within 5 years of initial surgery, magnitude of procedures, ‘survival’ of the reconstruction and effect of radiotherapy. RESULTS Although more intervention was seen in patients with implant-based reconstruction and the time-course over which autologous and implant-based reconstructions fail is different these did not reach statistical significance. Radiotherapy has a significant effect on failure of implant-based reconstruction. CONCLUSIONS Long-term, large studies of immediate reconstruction are required to assess adequately the impact of type of reconstruction on re-operation rates. The National Mastectomy and Breast Reconstruction Audit is ideally placed to provide answers to remaining questions about longevity of immediate breast reconstruction and the effect that late failure has on patient satisfaction. .

Abstract Background Although effective local control is the primary goal of surgery for breast cancer, the long-term aesthetic outcome is also important. Nipple-sparing mastectomy aims to address this, but there is no consensus on its clinical application. Evidence relating to oncological safety, surgical technique and early data on aesthetic outcome was reviewed. Methods The review was based on a PubMed search using the terms ‘nipple-sparing’ or ‘subcutaneous mastectomy’ and ‘breast cancer’. Results Large pathological studies report occult nipple involvement with cancer in 5·6–31 per cent, reflecting variation in inclusion criteria. Recent clinical series with careful patient selection report local recurrence in less than 5 per cent of patients. The incidence of cancer in the retained nipple after risk-reducing mastectomy is less than 1 per cent. Nipple necrosis rates range up to 8 and 16 per cent for total and partial necrosis respectively. Variations in outcome result from differences in extent of resection, placement of incisions and type of breast reconstruction. Conclusion Nipple-sparing mastectomy is an acceptable technique for women undergoing risk-reducing mastectomy. In the therapeutic setting, it may be offered to patients with smaller tumours far from the nipple and favourable pathological features. Women should be counselled about nipple necrosis and the potential for local recurrence. .

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Purpose Although breast-conserving surgery is a standard approach for patients with breast cancer, mastectomy often becomes necessary. Surgical options now include nipple-sparing mastectomy but its oncological safety is still controversial. This study evaluates frequency and patterns of occult nipple involvement in a large contemporary cohort of patients with the retroareolar margin as possible indicator of nipple involvement. Patients and Methods Three hundred sixteen consecutive mastectomy specimens (232 therapeutic, 84 prophylactic) with grossly unremarkable nipples were evaluated by coronal sections through the entire nipple and subareolar tissue. Extent and location of nipple involvement by carcinoma was assessed with the tissue deep to the skin as potential retroareolar en-face resection margin. Results Seventy-one percent of nipples from therapeutic mastectomies showed no pathologic abnormality, 21% had ductal carcinoma in situ (DCIS), invasive carcinoma (IC), or lymphovascular invasion (LVI), and 8% lobular neoplasia (lobular carcinoma in situ). Human epidermal growth factor receptor 2 amplification, tumor size, and tumor-nipple distance were associated with nipple involvement by multivariate analysis (P = .0047, .0126, and .0176); histologic grade of both DCIS (P = .002) and IC (P = .03), LVI (P = .03), and lymph node involvement (P = .02) by univariate analysis. Nipple involvement by IC or DCIS was identified in the retroareolar margin with a sensitivity of 0.8 and a negative predictive value of 0.96. None of the 84 prophylactic mastectomies showed nipple involvement by IC or DCIS. Conclusion Nipple-sparing mastectomy may be suitable for selected cases of breast carcinoma with low probability of nipple involvement by carcinoma and prophylactic procedures. A retroareolar en-face margin may be used to test for occult involvement in patients undergoing nipple-sparing mastectomy. .

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Abstract Background This prospective study aimed to build a predictive model using preoperative information to aid selection for nipple-sparing mastectomy. Methods Two hundred consecutive skin-sparing mastectomy specimens without overt nipple involvement were evaluated. Demographic, preoperative pathology and imaging information was collected. Nipple specimens (2 × 2 × 2 cm) were sectioned at 3-mm intervals. Haematoxylin and eosin-stained slides were examined by a breast pathologist for involvement by tumour. Logistic regression analyses of 65 therapeutic procedures identified factors associated with occult involvement and created a predictive model. This was tested on specimens from a further 65 therapeutic procedures. Results Occult nipple involvement was noted in 32 (24·6 per cent) of 130 mastectomy specimens. In the training set, imaging diameter of the lesion and its distance from the nipple predicted nipple involvement on univariable analysis (P = 0·011 and P = 0·014 respectively). The multivariable logistic regression model was validated in the test set. The areas under the receiver–operating characteristic curve were 0·824 and 0·709 for the training and test sets respectively. Conclusion Three-quarters of women undergoing mastectomy did not have occult nipple involvement. A clinical tool including tumour size and distance from the nipple has been developed to improve patient selection for nipple-sparing mastectomy. .

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Abstract The Editors welcome topical correspondence from readers relating to articles published in the Journal. Responses can be sent electronically via the BJS website (www.bjs.co.uk) or by post. All letters will be reviewed and, if approved, appear on the website. A selection of these will be edited and published in the Journal. Letters must be no more than 250 words in length. Letters submitted by post should be typed on A4-sized paper in double spacing and should be accompanied by a disk..

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Background Participation in research can be beneficial for patients and healthcare providers, but may prove demanding at patient, clinician and organizational levels. Patient representatives are supportive of online research to overcome these challenges. The aim of this pilot study was to develop an online recruitment platform and test its feasibility and acceptability while evaluating the accuracy of participant-reported data.Methods The online research platform was developed in a 1-day 'hackathon' with a digital design company. Women who underwent implant-based breast reconstruction in 2011-2016 were invited by letter containing the web address (URL) of the study site and their unique study number. Once online, participants learned about the study, consented, entered data on demographics, treatment received and patient-reported outcome measures (BREAST-Q™), and booked an appointment for a single hospital visit for three-dimensional surface imaging (3D-SI). Real-time process evaluation was performed. The primary endpoint was recruitment rate.Results The recruitment rate was 40 per cent. Of the 100 women, 50 logged on to the platform and 40 completed the process through to 3D-SI. The majority of discontinuations after logging on occurred between consenting and entering demographics (3 women, 6 per cent), and between completing the BREAST-Q and booking an appointment for 3D-SI using the online calendar (3 women, 6 per cent). All women completed the online BREAST-Q™ once started. Participants took a median of 23 minutes to complete the online process. Patient-reported clinical data were accurate in 12 of 13 domains compared with electronic records (95 per cent concordance). Process evaluation demonstrated acceptability.Conclusion The results of this pilot demonstrate the online platform to be acceptable, feasible, and accurate for this population from a single institution. The low-burden design may enable participation from centres with less research support and participants from hard-to-reach groups or dispersed geographical locations, but with online access..

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