Antonio Toesca1, Claudia Sangalli2, Patrick Maisonneuve3, Giulia Massari1, Antonia Girardi1, Jennifer L Baker4, Germana Lissidini1, Alessandra Invento1, Gabriel Farante1, Giovanni Corso1,5, Mario Rietjens6, Nickolas Peradze1, Alessandra Gottardi6, Francesca Magnoni1, Luca Bottiglieri7, Matteo Lazzeroni8, Emilia Montagna9, Piergiorgio Labo10, Roberto Orecchia11, Viviana Galimberti1, Mattia Intra1, Virgilio Sacchini1,5,12, Paolo Veronesi1,5. 1. Division of Breast Surgery, European Institute of Oncology IRCCS, Milan, Italy. 2. Data Management, European Institute of Oncology IRCCS, Milan, Italy. 3. Division of Epidemiology and Biostatistics, IEO European Institute of Oncology IRCCS, Milan, Italy. 4. Breast Surgery Division, Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles CA. 5. University of Milan School of Medicine, Milan, Italy. 6. Division of Plastic and Reconstructive Surgery, European Institute of Oncology IRCCS, Milan, Italy. 7. Division of Pathology, European Institute of Oncology IRCCS, Milan, Italy. 8. Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy. 9. Division of Medical Senology, European Institute of Oncology IRCCS, Milan, Italy. 10. Operating Theatre, European Institute of Oncology IRCCS, Milan, Italy. 11. Scientific Direction, European Institute of Oncology IRCCS, Milan, Italy. 12. Breast Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.
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.
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.