Long-term oncological outcomes of robotic mastectomy for breast cancer: a randomized clinical trial

Robotic nipple-sparing mastectomy (RNSM) has emerged over the past decade as a minimally invasive alternative to conventional open nipple-sparing mastectomy (NSM), with the aim of improving cosmetic and patient-reported outcomes while preserving oncological safety. Although feasibility, perioperative safety, and quality-of-life outcomes have been reported1–3, the lack of long-term comparative oncological data has remained a major barrier to widespread clinical and regulatory acceptance. This research letter reports the long-term oncological outcomes of the first randomized controlled trial comparing RNSM with open NSM in patients with breast cancer. The single-centre, open-label, phase III randomized trial enrolled 80 women between March 2017 and December 2018 who were eligible for NSM with immediate reconstruction1. Participants were randomized 1:1 to undergo RNSM using the Da Vinci Xi® platform or conventional open NSM. The trial was originally powered to detect differences in patient-reported quality-of-life outcomes although long-term oncological outcomes were prespecified secondary endpoints. For the present analysis, patients undergoing prophylactic mastectomy were excluded, leaving 69 patients with invasive breast cancer or ductal carcinoma in situ (DCIS) for evaluation of oncologic outcomes.