Robotic nipple-sparing mastectomy (NSM) is gaining traction as a potential advancement in breast cancer surgery, offering improved aesthetic outcomes and potentially reduced morbidity. A prospective, multicenter randomized controlled trial (NCT05720039) is currently underway to evaluate the safety, oncologic outcomes, and patient-reported outcomes of robotic NSM compared to open NSM for early-stage breast cancer.
The Rise of Robotic NSM
Nipple-sparing mastectomies have become increasingly popular due to their superior aesthetic results. While randomized controlled trials comparing NSM to skin-sparing mastectomy are lacking, studies on NSM for prophylaxis and early breast cancer treatment have demonstrated comparable oncologic outcomes and low recurrence rates. However, a common side effect of NSM is decreased nipple sensation, often resulting in permanent numbness, believed to be caused by nerve transection and retraction during the procedure.
The robotic approach to NSM aims to address these limitations. Robotic NSM allows for excellent visualization through small incisions, potentially minimizing nerve damage. The procedure is performed through a hidden 3-cm incision along the anterior axillary line, and the use of CO2 insufflation instead of manual retraction may further contribute to improved sensation in the flaps and nipples.
Ongoing Clinical Trial
The ongoing clinical trial (NCT05720039), sponsored by Intuitive Surgical, utilizes the da Vinci Single Port Surgical System. Patients undergoing NSM, standard lymph node evaluation, and reconstruction are included in the study. Reconstruction is performed according to the plastic surgeon's preference, involving either direct-to-implant or tissue expander placement followed by implant exchange.
Case Report
A case report illustrates the potential benefits of robotic NSM. A premenopausal woman with a 1.8-cm ER-positive, PR-negative, HER2-negative breast cancer underwent neoadjuvant chemotherapy plus pembrolizumab, achieving an excellent clinical response. She then underwent bilateral robotic NSM with immediate prepectoral implant reconstruction and sentinel lymph node biopsy, resulting in a pathological complete response (pCR). The patient experienced an uncomplicated postoperative course and is currently in follow-up per clinical trial guidelines.
Future Directions
The results of the ongoing clinical trial are eagerly awaited to determine the oncologic safety and efficacy of robotic NSM. This trial will provide valuable insights into the potential of robotic surgery to improve outcomes and reduce morbidity in breast cancer treatment.