A Randomized Trial of Robotic Mastectomy Versus Open Surgery in Women With Breast Cancer or BrCA Mutation

Abstract

Objective:The aim of this study was 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 versus open procedure. Respect to baseline, physical and sexual well-being domains remained stable after robotic mastectomy, whereas they significantly decreased after open procedure (P < 0.02). The overall Body Image Scale questionnaire score was 20.7 ± 13.8 versus 9.9 ± 5.1 in the robotic versus open groups respectively, P < 0.0001. At median follow-up 28.6months (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

Breast Cancer Surgery: New Issues

“…Its safety and feasibility have been the subject of several studies [98]. A very recent phase III randomized controlled trial has concluded that robotic NSM is a safe procedure to perform given that its complications are similar to those of the traditional technique and that no local events have been observed at a median follow-up of 28.6 months [99]. The role of the minimally invasive technique in improving BC patients' quality of life and in minimizing post-operative complications is also analyzed in a recent comparative study by Chen and colleagues, who have reported a decreased incidence of lymphedema after the Da Vinci Robot-assisted axillary lymph-node dissection during NSM.…”

Safe Technical Innovation

“… 2 – 4 However, these benefits come with a prolonged operative time, uncertainty surrounding its oncologic safety, and potentially increased costs. Recently, Toesca et al 5 reported outcomes from the first randomized controlled trial comparing RNSM to open NSM. Among 80 women with breast cancer or a BRCA mutation, RNSM took significantly longer but produced better quality of life for patients after surgery as determined by the Breast-Q and Body Image Scale instruments.…”

Mastectomy and Immediate Breast Reconstruction with Pre-Pectoral or Sub- Pectoral Implant: Assessing Clinical Practice, Post-Surgical Outcomes, Patient’s Satisfaction and Cost

“…In our center, among 2112 mastectomies performed between January 2016 and July 2020, IBR-rate was 40.5%: 35.4% (618/1748) for primary BC, 47.9% (105/219) for local recurrence and 91% (132/145) for prophylactic mastectomies. Several new procedures are been developed, as robotic procedures [ 12 – 15 ], pre-pectoral implant-IBR with or without synthetic or acellular dermal matrix [ 7 , 16 – 21 ]. However, it was reported that use of meshes significantly increases the cost of surgery [ 16 ].…”