Mastectomy with Reconstruction Including Robotic Endoscopic Surgery (MARRES): a prospective cohort study of the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG) and Korean Breast Cancer Study Group (KBCSG)

Jai Min Ryu, Jeea Lee, Jeeyeon Lee, BeomSeok Ko, Joo Heung Kim, Hyukjai Shin, Hyung Seok Park, Korea Robot-endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG), Jai Min Ryu, Jeea Lee, Jeeyeon Lee, BeomSeok Ko, Joo Heung Kim, Hyukjai Shin, Hyung Seok Park, Korea Robot-endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG)

Abstract

Background: Robotic nipple-sparing mastectomy (RNSM) has emerged as a new treatment option for breast cancer and risk-reducing mastectomy (RRM) for women who have a high risk of pathogenic variants. Even though several studies have reported that RNSM is a feasible procedure, some argue that it should only be performed by specialized surgeons, and data on oncologic outcomes and patient-reported outcomes (PROs) are limited. Recently, the United States Food and Drug Administration and several surgeons warned that robotic breast surgery should be performed only by specialized surgeons and recommended that the benefits, risks, and alternatives of all available treatment options be discussed with patients so they can make informed treatment decisions. The Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG) has been established to evaluate, standardize, and teach this state-of-the-art procedure. We have designed a multicenter prospective cohort study entitled Mastectomy with Reconstruction Including Robot Endoscopic Surgery (MARRES) to report surgical, PRO, and oncologic outcomes.

Methods: MARRES is a multi-institution cohort study prospectively collecting data from patients undergoing mastectomy and reconstruction. The patient inclusion criteria are adult women older than 19 with breast cancer or a high risk of breast cancer (patients with BRCA1/2, TP53, PALB2 mutations, etc.), who have scheduled therapeutic or RRM and want immediate reconstruction. Surgical outcomes, including pre- and postoperative photos, oncologic outcomes, cost-effectiveness, and PRO, are collected. The primary endpoints are postoperative complication rates within 30 postoperative days and the Clavien-Dindo grade of postoperative complications within 180 postoperative days. The secondary endpoints are 5-year postoperative recurrence-free survival and cancer incidence rate (for those who underwent RRM), patient satisfaction with reconstruction expectations preoperative (baseline) and results within 6 to 12 postoperative months, surgeon satisfaction with postoperative results in 6 postoperative months, and cost-effectiveness of the definitive surgery. Patient recruitment will be completed in April 2025, and the target number of enrolled patients is 2000.

Discussion: This study will provide evidence about the surgical outcomes, oncologic outcomes, and patient satisfaction with RNSM and endoscopic nipple-sparing mastectomy (NSM), compared with conventional NSM.

Trial registration: ClinicalTrials.gov Identifier NCT04585074. Registered April 8, 2020.

Keywords: Breast neoplasms; Conventional nipple-sparing mastectomy; Endoscopic nipple-sparing mastectomy; Germline BRCA1/2 mutation; Immediate breast reconstruction; Minimally invasive procedure; Robotic-assisted nipple-sparing mastectomy.

Conflict of interest statement

Hyung Seok Park received honoraria from AstraZeneca, Takeda, Ethicon, Medtronic, and Intuitive Surgical. Jai Min Ryu received a research grant from Medtronic for this study. No other relationships or activities have occurred that could appear to have influenced the submitted work.

© 2023. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart of the prospective cohort study

References

    1. Toth BA, Lappert P. Modified skin incisions for mastectomy: the need for plastic surgical input in preoperative planning. Plast Reconstr Surg. 1991;87(6):1048–1053. doi: 10.1097/00006534-199106000-00006.
    1. Cocquyt VF, Blondeel PN, Depypere HT, Van De Sijpe KA, Daems KK, Monstrey SJ, Van Belle SJ. Better cosmetic results and comparable quality of life after skin-sparing mastectomy and immediate autologous breast reconstruction compared to breast conservative treatment. Br J Plast Surg. 2003;56(5):462–470. doi: 10.1016/S0007-1226(03)00198-X.
    1. Reefy S, Patani N, Anderson A, Burgoyne G, Osman H, Mokbel K. Oncological outcome and patient satisfaction with skin-sparing mastectomy and immediate breast reconstruction: a prospective observational study. BMC Cancer. 2010;10:171. doi: 10.1186/1471-2407-10-171.
    1. Mota BS, Riera R, Ricci MD, Barrett J, de Castria TB, Atallah AN, Bevilacqua JL: Nipple- and areola-sparing mastectomy for the treatment of breast cancer. Cochrane Database Syst Rev. 2016;11(11):CD008932.
    1. Agha RA, Al Omran Y, Wellstead G, Sagoo H, Barai I, Rajmohan S, Borrelli MR, Vella-Baldacchino M, Orgill DP, Rusby JE. Systematic review of therapeutic nipple-sparing versus skin-sparing mastectomy. BJS Open. 2019;3(2):135–145. doi: 10.1002/bjs5.50119.
    1. Alsharif E, Ryu JM, Choi HJ, Nam SJ, Kim SW, Yu J, Chae BJ, Lee SK, Lee JE: Oncologic Outcomes of Nipple-Sparing Mastectomy with Immediate Breast Reconstruction in Patients with Tumor-Nipple Distance Less than 2.0 cm. J Breast Cancer. 2019;22(4):613–623.
    1. Weber WP, Haug M, Kurzeder C, Bjelic-Radisic V, Koller R, Reitsamer R, Fitzal F, Biazus J, Brenelli F, Urban C, et al. Oncoplastic Breast Consortium consensus conference on nipple-sparing mastectomy. Breast Cancer Res Treat. 2018;172(3):523–537. doi: 10.1007/s10549-018-4937-1.
    1. Corso G, De Lorenzi F, Vicini E, Pagani G, Veronesi P, Sargenti M, Magnoni F, Naninato P, Maisonneuve P, Sangalli C et al: Nipple-sparing mastectomy with different approaches: surgical incisions, complications, and cosmetic results. Preliminary results of 100 consecutive patients at a single center. J Plast Reconstr Aesthet Surg. 2018;71(12):1751–1760.
    1. Lanthaler M, Spinelli R, Tasch C, Sieb M, Harfmann M, Nitto A, Pierer G, Bauer T. Influence of Incision Site on Postoperative Outcome in Skin-/Nipple-Sparing Mastectomy: Is There a Difference between Radial and Inframammary Incision? Breast Care (Basel) 2020;15(3):265–271. doi: 10.1159/000502408.
    1. Park S, Yoon C, Bae SJ, Cha C, Kim D, Lee J, Ahn SG, Roh TS, Kim YS, Jeong J. Comparison of complications according to incision types in nipple-sparing mastectomy and immediate reconstruction. Breast (Edinburgh, Scotland) 2020;53:85–91. doi: 10.1016/j.breast.2020.06.009.
    1. Sakamoto N, Fukuma E, Higa K, Ozaki S, Sakamoto M, Abe S, Kurihara T, Tozaki M. Early results of an endoscopic nipple-sparing mastectomy for breast cancer. Indian J Surg Oncol. 2010;1(3):232–239. doi: 10.1007/s13193-011-0057-7.
    1. Friedlander LD, Sundin J, Bakshandeh N. Endoscopy mastectomy and breast reconstruction: endoscopic breast surgery. Aesthetic Plast Surg. 1995;19(1):27–29. doi: 10.1007/BF00209307.
    1. Mok CW, Lai HW. Endoscopic-assisted surgery in the management of breast cancer: 20 years review of trend, techniques and outcomes. Breast (Edinburgh, Scotland) 2019;46:144–156. doi: 10.1016/j.breast.2019.05.013.
    1. Toesca A, Peradze N, Manconi A, Nevola Teixeira LF: Reply to the letter to the editor "Robotic-assisted Nipple Sparing Mastectomy: A feasibility study on cadaveric models" by Sarfati B. et al. J Plast Reconstr Aesthet Surg. 2017;70(4):558–560.
    1. Park HS, Kim JH, Lee DW, Song SY, Park S, Kim SI, Ryu DH, Cho YU. Gasless Robot-Assisted Nipple-Sparing Mastectomy: A Case Report. J Breast Cancer. 2018;21(3):334–338. doi: 10.4048/jbc.2018.21.e45.
    1. Angarita FA, Castelo M, Englesakis M, McCready DR, Cil TD. Robot-assisted nipple-sparing mastectomy: systematic review. Br J Surg. 2020;107(12):1580–1594.
    1. Margenthaler JA. Robotic Mastectomy-Program Malfunction? JAMA Surg. 2020;155(6):461–462. doi: 10.1001/jamasurg.2019.6361.
    1. Jackson RS, Sanders T, Park A, Buras R, Liang W, Harris C, Mylander C, Rosman M, Holton L, Singh D, et al. Prospective Study Comparing Surgeons' Pain and Fatigue Associated with Nipple-Sparing versus Skin-Sparing Mastectomy. Ann Surg Oncol. 2017;24(10):3024–3031. doi: 10.1245/s10434-017-5929-9.
    1. Ryu JM, Kim JY, Choi HJ, Ko B, Kim J, Cho J, et al. Robot-assisted nipple-sparing mastectomy with immediate breast reconstruction: an initial experience of the Korea robot-endoscopy minimal access breast surgery study group (KoREa-BSG). Ann Surg. 2022;275(5):985–91.
    1. Freeman BS. Subcutaneous mastectomy for benign breast lesions with immediate or delayed prosthetic replacement. Plast Reconstr Surg Transplant Bull. 1962;30:676–682. doi: 10.1097/00006534-196212000-00008.
    1. Hinton CP, Doyle PJ, Blamey RW, Davies CJ, Holliday HW, Elston CW. Subcutaneous mastectomy for primary operable breast cancer. Br J Surg. 1984;71(6):469–472. doi: 10.1002/bjs.1800710623.
    1. Headon HL, Kasem A, Mokbel K. The Oncological Safety of Nipple-Sparing Mastectomy: A Systematic Review of the Literature with a Pooled Analysis of 12,358 Procedures. Arch Plast Surg. 2016;43(4):328–338. doi: 10.5999/aps.2016.43.4.328.
    1. Mallon P, Feron JG, Couturaud B, Fitoussi A, Lemasurier P, Guihard T, Cothier-Savay I, Reyal F. The role of nipple-sparing mastectomy in breast cancer: a comprehensive review of the literature. Plast Reconstr Surg. 2013;131(5):969–984. doi: 10.1097/PRS.0b013e3182865a3c.
    1. Stanec Z, Žic R, Budi S, Stanec S, Milanović R, Vlajčić Z, Roje Z, Rudman F, Martić K, Held R, et al. Skin and nipple-areola complex sparing mastectomy in breast cancer patients: 15-year experience. Ann Plast Surg. 2014;73(5):485–491. doi: 10.1097/SAP.0b013e31827a30e6.
    1. Wu ZY, Kim HJ, Lee JW, Chung IY, Kim JS, Lee SB, Son BH, Eom JS, Kim SB, Gong GY, et al. Breast Cancer Recurrence in the Nipple-Areola Complex After Nipple-Sparing Mastectomy With Immediate Breast Reconstruction for Invasive Breast Cancer. JAMA Surg. 2019;154(11):1030–1037. doi: 10.1001/jamasurg.2019.2959.
    1. Gerber B, Krause A, Dieterich M, Kundt G, Reimer T. The oncological safety of skin sparing mastectomy with conservation of the nipple-areola complex and autologous reconstruction: an extended follow-up study. Ann Surg. 2009;249(3):461–468. doi: 10.1097/SLA.0b013e31819a044f.
    1. Benediktsson KP, Perbeck L. Survival in breast cancer after nipple-sparing subcutaneous mastectomy and immediate reconstruction with implants: a prospective trial with 13 years median follow-up in 216 patients. Eur J Surg Oncol. 2008;34(2):143–148. doi: 10.1016/j.ejso.2007.06.010.
    1. Moyer HR, Ghazi B, Daniel JR, Gasgarth R, Carlson GW. Nipple-sparing mastectomy: technical aspects and aesthetic outcomes. Ann Plast Surg. 2012;68(5):446–450. doi: 10.1097/SAP.0b013e3182394bba.
    1. Sherman KA, Woon S, French J, Elder E. Body image and psychological distress in nipple-sparing mastectomy: the roles of self-compassion and appearance investment. Psychooncology. 2017;26(3):337–345. doi: 10.1002/pon.4138.
    1. Sacchini V, Pinotti JA, Barros AC, Luini A, Pluchinotta A, Pinotti M, Boratto MG, Ricci MD, Ruiz CA, Nisida AC, et al. Nipple-sparing mastectomy for breast cancer and risk reduction: oncologic or technical problem? J Am Coll Surg. 2006;203(5):704–714. doi: 10.1016/j.jamcollsurg.2006.07.015.
    1. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4. 2022. Available from: . Accessed 6 Dec 2022.
    1. Eaves FF, 3rd, Bostwick J, 3rd, Nahai F, Murray DR, Styblo TM, Carlson GW: Endoscopic techniques in aesthetic breast surgery. Augmentation, mastectomy, biopsy, capsulotomy, capsulorrhaphy, reduction, mastopexy, and reconstructive techniques. Clin Plastic Surg. 1995;22(4):683–695.
    1. Yamashita K, Shimizu K: Endoscopic video-assisted breast surgery: procedures and short-term results. J Nippon Med Sch. 2006;73(4):193–202.
    1. Ho WS, Ying SY, Chan AC. Endoscopic-assisted subcutaneous mastectomy and axillary dissection with immediate mammary prosthesis reconstruction for early breast cancer. Surg Endosc. 2002;16(2):302–306. doi: 10.1007/s004640000203.
    1. Kitamura K, Ishida M, Inoue H, Kinoshita J, Hashizume M, Sugimachi K. Early results of an endoscope-assisted subcutaneous mastectomy and reconstruction for breast cancer. Surgery. 2002;131(1 Suppl):S324–329. doi: 10.1067/msy.2002.120120.
    1. Lai HW, Wu HS, Chuang KL, Chen DR, Chang TW, Kuo SJ, Chen ST, Kuo YL. Endoscopy-Assisted Total Mastectomy Followed by Immediate Pedicled Transverse Rectus Abdominis Musculocutaneous (TRAM) Flap Reconstruction: Preliminary Results of 48 Patients. Surg Innov. 2015;22(4):382–389. doi: 10.1177/1553350614546003.
    1. Kuo YL, Chang CH, Chang TY, Chien HF, Liao LM, Hung CS, Lin SL, Chen ST, Chen DR, Lai HW. Endoscopy-Assisted Total Mastectomy with and without Immediate Reconstruction: An Extended Follow-Up Multicenter Study. Plastic Reconstruct Surg. 2021;147(2):267–278. doi: 10.1097/PRS.0000000000007587.
    1. Lee HY, Chang YW, Yu DY, Lee TY, Kim DW, Kim WY, Jung SP, Woo SU, Lee JB, Son GS. Comparison of Single Incision Endoscopic Nipple-Sparing Mastectomy and Conventional Nipple-Sparing Mastectomy for Breast Cancer Based on Initial Experience. J Breast Cancer. 2021;24(2):196–205. doi: 10.4048/jbc.2021.24.e18.
    1. Rathat G, Herlin C, Bonnel C, Captier G, Duraes M. Endoscopic Nipple-Sparing Mastectomy with Immediate Prepectoral Implant-Based Reconstruction: A Case Report. Am J Case Rep. 2019;20:1812–1816. doi: 10.12659/AJCR.919669.
    1. Leal Ghezzi T, Campos Corleta O. 30 Years of Robotic Surgery. World J Surg. 2016;40(10):2550–2557. doi: 10.1007/s00268-016-3543-9.
    1. Lee J, Park HS, Lee H, Lee DW, Song SY, Lew DH, Kim JY, Park S, Kim SI. Post-Operative Complications and Nipple Necrosis Rates Between Conventional and Robotic Nipple-Sparing Mastectomy. Front Oncol. 2020;10:594388. doi: 10.3389/fonc.2020.594388.
    1. Toesca A, Invento A, Massari G, Girardi A, Peradze N, Lissidini G, Sangalli C, Maisonneuve P, Manconi A, Gottardi A, et al. Update on the Feasibility and Progress on Robotic Breast Surgery. Ann Surg Oncol. 2019;26(10):3046–3051. doi: 10.1245/s10434-019-07590-7.
    1. Sanson C, Roulot A, Honart JF, Rimareix F, Leymarie N, Sarfati B: Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A prospective Study of 138 Procedures. Chirurgia (Bucharest, Romania : 1990). 2021; 116(2):135–142.
    1. Lai HW, Chen ST, Mok CW, Lin YJ, Wu HK, Lin SL, Chen DR, Kuo SJ. Robotic versus conventional nipple sparing mastectomy and immediate gel implant breast reconstruction in the management of breast cancer- A case control comparison study with analysis of clinical outcome, medical cost, and patient-reported cosmetic results. J Plast Reconstr Aesthet Surg. 2020;73(8):1514–1525. doi: 10.1016/j.bjps.2020.02.021.
    1. Houvenaeghel G, Barrou J, Jauffret C, Rua S, Sabiani L, Van Troy A, Buttarelli M, Blache G, Lambaudie E, Cohen M, et al. Robotic Versus Conventional Nipple-Sparing Mastectomy With Immediate Breast Reconstruction. Front Oncol. 2021;11:637049. doi: 10.3389/fonc.2021.637049.
    1. Loh ZJ, Wu TY, Cheng FT. Evaluation of the Learning Curve in Robotic Nipple-sparing Mastectomy for Breast Cancer. Clin Breast Cancer. 2021;21(3):e279–e284. doi: 10.1016/j.clbc.2020.09.013.
    1. Kuo WL, Huang JJ, Huang YT, Chueh LF, Lee JT, Tsai HP, Chen SC. Robot-assisted Mastectomy Followed by Immediate Autologous Microsurgical Free Flap Reconstruction: Techniques and Feasibility in Three Different Breast Cancer Surgical Scenarios. Clin Breast Cancer. 2020;20(1):e1–e8. doi: 10.1016/j.clbc.2019.06.018.
    1. Park HS, Lee J, Lee DW, Song SY, Lew DH, Kim SI, Cho YU. Robot-assisted Nipple-sparing Mastectomy with Immediate Breast Reconstruction: An Initial Experience. Sci Rep. 2019;9(1):15669. doi: 10.1038/s41598-019-51744-2.
    1. Lai HW, Toesca A, Sarfati B, Park HS, Houvenaeghel G, Selber JC, Cheng FT, Kuo WL, Peradze N, Song SY, et al. Consensus Statement on Robotic Mastectomy-Expert Panel From International Endoscopic and Robotic Breast Surgery Symposium (IERBS) 2019. Ann Surg. 2020;271(6):1005–1012. doi: 10.1097/SLA.0000000000003789.
    1. Toesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, et al. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast (Edinburgh, Scotland) 2017;31:51–56. doi: 10.1016/j.breast.2016.10.009.
    1. Shin H. Current Trends in and Indications for Endoscopy-Assisted Breast Surgery for Breast Cancer. Adv Exp Med Biol. 2021;1187:567–590. doi: 10.1007/978-981-32-9620-6_30.
    1. Ueda S, Tamaki Y, Yano K, Okishiro N, Yanagisawa T, Imasato M, Shimazu K, Kim SJ, Miyoshi Y, Tanji Y, et al. Cosmetic outcome and patient satisfaction after skin-sparing mastectomy for breast cancer with immediate reconstruction of the breast. Surgery. 2008;143(3):414–425. doi: 10.1016/j.surg.2007.10.006.
    1. Potter S, Conroy EJ, Cutress RI, Williamson PR, Whisker L, Thrush S, Skillman J, Barnes NLP, Mylvaganam S, Teasdale E, et al. Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study. Lancet Oncol. 2019;20(2):254–266. doi: 10.1016/S1470-2045(18)30781-2.

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