A randomized trial of robotic mastectomy versus open surgery in women with breast cancer or BRCA mutation

Objective: To compare robotic mastectomy with open classical technique outcomes in breast cancer patients. Summary background data: As the use of robotic nipple sparing mastectomy continues to rise, improved understanding of the surgical, oncologic and quality of life outcomes is imperative for appropriate patient selection as well as to better understand indications, limits, advantages and dangers. Methods: In a phase III, open label, single center, randomized controlled trial involving 80 women with breast cancer (69) or with BRCA mutation (11), we compared the outcome of robotic and open nipple sparing mastectomy. Primary outcomes were surgical complications and quality of life using specific validated questionnaires. Secondary objective included oncologic outcomes. Results: Robotic procedure was 1 hour and 18 minutes longer than open (P < 0.001). No differences in the number or type of complications (P = 0.11) were observed. Breast-Q scores in satisfaction with breasts, psychosocial, physical and sexual well-being were significantly higher after robotic mastectomy vs open procedure. Respect to baseline, physical and sexual well-being domains remained stable after robotic mastectomy while they significantly decreased after open procedure (P<= 0.02). The overall Body Image Scale questionnaire score was 20.7 +/- 13.8 vs. 9.9 +/- 5.1 in the robotic vs open groups respectively, P < 0.0001. At median follow-up 28.6 months (range 3.7-43.3), no local events were observed. Conclusions: Complications were similar among groups upholding the robotic technique to be safe. Quality of life was maintained after robotic mastectomy while significantly decrease after open surgery. Early follow up confirm no premature local failure. ClinicalTrials.gov NCT03440398.