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

Antonio Toesca, Claudia Sangalli, Patrick Maisonneuve, Giulia Massari, Antonia Girardi, Jennifer L Baker, Germana Lissidini, Alessandra Invento, Gabriel Farante, Giovanni Corso, Mario Rietjens, Nickolas Peradze, Alessandra Gottardi, Francesca Magnoni, Luca Bottiglieri, Matteo Lazzeroni, Emilia Montagna, Piergiorgio Labo, Roberto Orecchia, Viviana Galimberti, Mattia Intra, Virgilio Sacchini, Paolo Veronesi, Antonio Toesca, Claudia Sangalli, Patrick Maisonneuve, Giulia Massari, Antonia Girardi, Jennifer L Baker, Germana Lissidini, Alessandra Invento, Gabriel Farante, Giovanni Corso, Mario Rietjens, Nickolas Peradze, Alessandra Gottardi, Francesca Magnoni, Luca Bottiglieri, Matteo Lazzeroni, Emilia Montagna, Piergiorgio Labo, Roberto Orecchia, Viviana Galimberti, Mattia Intra, Virgilio Sacchini, Paolo Veronesi

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.

Conflict of interest statement

The authors report no conflicts of interest.

Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

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Source: PubMed

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