A Comparison of the Performance of EndoPredict Clinical and NHS PREDICT in 120 Patients Treated for ER-positive Breast Cancer.

BACKGROUND: Computational algorithms, such as NHS PREDICT, have been developed using cancer registry data to guide decisions regarding adjuvant chemotherapy. They are limited by biases of the underlying data. Recent breakthroughs in molecular biology have aided the development of genomic assays which provide superior clinical information. In this study, we compared the performance in risk stratification of EndoPredict Clinical (EPClin, a composite of clinical data and EndoPredict) and PREDICT in a cohort of patients with breast cancer considered potential candidates for chemotherapy by the clinicians. MATERIALS AND METHODS: One hundred and twenty patients with biopsy-proven oestrogen receptor positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer who underwent surgery were included. EPClin and PREDICT were determined for every tumour, and the results were compared. RESULTS: Using EPClin scores performed on 120 tumours, the cohort was stratified into low- (n=60) and high-risk (n=60) groups leading to 50% reduction in total chemotherapy prescriptions. PREDICT differentiated the patients into low- (n=45), intermediate- (n=33), and high-risk groups (n=42). Discordance between scores was demonstrated for 50 (41.66%) tumours. Nine (20%) out of 45 patients with low PREDICT scores had high EPClin scores and would otherwise not have received chemotherapy if the NHS PREDICT tool had been used alone. Eight (19%) out of 42 patients at high risk by PREDICT were reclassified as being at low risk by EPClin and avoided adjuvant chemotherapy. The sensitivity, specificity, positive predictive value and negative predictive value for NHS PREDICT to predict the potential need for chemotherapy as determined by EPClin were 85%, 51%, 68% and 80%, respectively. CONCLUSION: To our knowledge, this is the first clinical study to compare EPClin and PREDICT. The data indicate that computational algorithms such as NHS PREDICT may not accurately predict the need for chemotherapy leading to overtreatment, undertreatment or uncertainty and anxiety in a significant proportion of patients. This underscores the importance of more personalized prognostic tools.

Clinical outcome and patient satisfaction with the use of bovine-derived acellular dermal matrix (SurgiMend™) in implant based immediate reconstruction following skin sparing mastectomy: A prospective observational study in a single centre.

INTRODUCTION: The advent of acellular dermal matrix devices (ADMs) has enhanced both the scope of implant-based immediate breast reconstruction (IBR) following skin sparing mastectomy (SSM) for the treatment or risk reduction of breast cancer. Currently, there are a wide range of options available for the use of ADMs. METHODS: This is a prospective observational single institution study of 118 consecutive patients undergoing a total of 164 SSM and IBR procedures either for treatment for breast cancer or for risk reduction, between 2012 and 2014. IBR was performed using an implant and bovine-derived ADM (SurgiMend™). Nipple sparing mastectomy (NSM) accounted for 103 procedures. IBR was performed as a single stage procedure in 23% of patients. The primary endpoint of this prospective study was the explantation rate and secondary endpoints included quality of life, patient satisfaction, aesthetic outcome assessed objectively, surgical complications, overall and disease free survival. RESULTS: Forty-six patients (39%) had a bilateral and 72 underwent a unilateral SSM. Of those who underwent a unilateral SSM, 25 had a contralateral adjustment procedure. Out of 164 procedures, 117 (71%) were for the treatment of breast cancer. Sixty-one patients received chemotherapy (52%) and 32 (27%) had radiotherapy. In this study 27 patients underwent post-mastectomy radiotherapy. At a mean follow of 21 months, the explantation rate was 1.2%, 4% (6 patients) developed wound complications. The patient satisfaction with the procedure was found to be very high. The mean Breast Q Score was 85 and the mean overall patient satisfaction rating was 9 out of a possible 10. The mean objective assessment score was 8.9 out of a possible 10 and the mean subjective capsular contracture severity score was 2.9 out of 10. There were two cases of local recurrence (1.7%), one distant recurrence (0.8%) and one patient died of metastatic breast cancer (0.8%). Overall survival was 99.2% and locoregional disease free survival (LRFS) was 98.3%. One patient (0.8%) developed a mild inflammatory reaction secondary to the underlying mesh. CONCLUSIONS: SurgiMend™ is an effective adjunct to implant based IBR following SSM. It is associated with a very low rate of implant loss and a high level of patient satisfaction and is associated with a very low incidence of inflammatory reaction. Neither prior radiotherapy nor post-mastectomy radiotherapy (PMRT) represents a contraindication to its use.

Towards optimal management of the axilla in the context of a positive sentinel node biopsy in early breast cancer.

The sentinel lymph node biopsy (SLNB) was initially pioneered for staging melanoma in 1994 and it has been subsequently validated by several trials, and has become the new standard of care for patients with clinically node negative invasive breast cancer. The focussed examination of fewer lymph nodes in addition to improvements in histopathological and molecular analysis has increased the rate at which micrometastases and isolated tumour cells are identified. In this article we review the literature regarding the optimal management of the axilla when the SLNB is positive for metastatic disease based on level 1 evidence derived from randomised clinical trials.