Capturing longer term surgical outcome measures as part of routine care of breast cancer patients.

INTRODUCTION: The transition away from routine clinical follow up after breast cancer towards imaging surveillance and patient-initiated contact limits opportunities for patients and doctors to communicate about the long-term effects of treatment. The ABS oncoplastic guidelines (2021) recommend that post-operative 2D images and patient-reported outcomes (PROMs) are routinely collected but give no guidance as to how best to implement this. METHODS: From December 2019 until March 2024, women due for their year 3 or 5 surveillance mammogram at The Royal Marsden Sutton site were invited to complete a BREAST-Q questionnaire and attend medical photography. Panel assessment of photographs was undertaken. Results were presented to the oncoplastic MDT, including summary PROMs and illustrative case presentations. Free-text comments were shared with the relevant teams. Associations between demographic or clinic-pathological factors and uptake were investigated. RESULTS: Of the 1211 women invited, 246 patients (20.3 %) completed BREAST-Q questionnaires, 182 (15.0 %) attended for medical photography and 114 (9.4 %) completed both. Uptake was not associated with age, ethnicity or surgical factors but patients with higher BMI were less likely to respond to the questionnaire. Patients who had undergone complex oncoplastic procedures were more likely to respond than those who had simple procedures. Patient-reported outcome results were in line with the published literature. CONCLUSION: Reviewing images with their paired PROMs and discussing free-text feedback was instructive for the team. Work is needed to identify barriers to patient participation and improve uptake to be representative of the overall patient population. Quantifying appearance in photographs would help summarise aesthetic outcome data.

Pre-operative Radiotherapy And Deep Inferior Epigastric Artery Perforator (DIEP) flAp study (PRADA): Aesthetic outcome and patient satisfaction at one year.

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.

Primary radiotherapy and deep inferior epigastric perforator flap reconstruction for patients with breast cancer (PRADA): a multicentre, prospective, non-randomised, feasibility study.

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.

A scoring system for 3D surface images of breast reconstruction developed using the Delphi consensus process.

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.

3-Dimensional objective aesthetic evaluation to replace panel assessment after breast-conserving treatment.

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.