Vera Lidwina Negenborn1, Danny Aschwin Young-Afat2, Rieky Elise Gustina Dikmans1, Jan Maerten Smit3, Henri Adolf Hubert Winters3, Johan Peter William Don Griot4, Johannes Wilhelmus Rembertus Twisk5, Pieter Quinten Ruhé6, Marcus Antonius Maria Mureau7, Oren Lapid8, Esther Moerman9, Adriaan Anne William Martinus van Turnhout10, Mathias Joseph Petrus Franciscus Ritt4, Mark-Bram Bouman3, Margriet Gezina Mullender11. 1. Department of Plastic, Reconstructive & Hand Surgery, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands; Research Institute, Amsterdam Public Health, Amsterdam, Netherlands. 2. Department of Plastic, Reconstructive & Hand Surgery, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands; Imaging Division, University Medical Center, Utrecht, Netherlands. 3. Department of Plastic, Reconstructive & Hand Surgery, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands; Alexander Monro Breast Cancer Hospital, Bilthoven, Netherlands. 4. Department of Plastic, Reconstructive & Hand Surgery, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands. 5. Department of Epidemiology & Biostatistics, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands. 6. Department of Plastic, Reconstructive & Hand Surgery, Meander Medical Centre, Amersfoort, Netherlands. 7. Department of Plastic and Reconstructive Surgery, Erasmus MC Cancer Institute, University Medical Centre Rotterdam, Rotterdam, Netherlands. 8. Department of Plastic, Reconstructive & Hand Surgery, Amsterdam UMC Academic Medical Center, University of Amsterdam, Netherlands. 9. Department of Plastic, Reconstructive & Hand Surgery, Amsterdam UMC Academic Medical Center, University of Amsterdam, Netherlands; Department of Plastic, Reconstructive and Hand Surgery, Onze Lieve Vrouwe Gasthuis Oost, Amsterdam, Netherlands. 10. Department of Plastic, Reconstructive & Hand Surgery, Tergooi Hospital, Hilversum, Netherlands. 11. Department of Plastic, Reconstructive & Hand Surgery, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands; Research Institute, Amsterdam Public Health, Amsterdam, Netherlands. Electronic address: m.mullender@vumc.nl.
Abstract
BACKGROUND: There is increasing interest in the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR). Suggested advantages are that ADMs facilitate one-stage IBBR and improve aesthetic outcomes. We compared immediate one-stage ADM-assisted IBBR with two-stage IBBR (current standard of care). Our previously reported secondary endpoint showed that one-stage ADM-assisted IBBR was associated with significantly more adverse outcomes. Here, we present the primary endpoint results aiming to assess whether one-stage IBBR with ADM provides higher patient-reported quality of life (QOL) compared with two-stage IBBR. METHODS: This multicentre, open-label, randomised controlled trial (BRIOS study) was done in eight hospitals in the Netherlands. We recruited women aged older than 18 years with breast carcinoma or a genetic predisposition who intended to undergo skin-sparing mastectomy and immediate IBBR. Participants were randomly assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. Randomisation was stratified by centre and indication for surgery (oncological or prophylactic) in blocks of ten participants. The primary endpoint was patient-reported QOL, as measured with the BREAST-Q (ie, health-related QOL scales and satisfaction scales), in the modified intention-to-treat population. The study follow-up is complete. This study is registered with the Netherlands Trial Register, number NTR5446. FINDINGS:Between April 14, 2013, and May 29, 2015, we enrolled 142 women, of whom 69 were randomly assigned toreceive one-stage ADM-assisted IBBR and 73 to receive two-stage IBBR. After exclusions, the modified intention-to-treat population comprised 60 patients in the one-stage group and 61 patients in the two-stage group. Of these, 48 women (mean follow-up 17·0 months [SD 7·8]) in the one-stage group and 44 women (17·2 months [SD 6·7]) in the two-stage group completed the BREAST-Q at least 1 year after implant placement. We found no significant differences in postoperative patient-reported QOL domains, including physical wellbeing (one-stage mean 78·0 [SD 14·1] vs two-stage 79·3 [12·2], p=0·60), psychosocial wellbeing (72·6 [17·3] vs 72·8 [19·6], p=0·95), and sexual wellbeing (58·0 [17·0] vs 57·1 [19·5], p=0·82), or in the patient-reported satisfaction domains: satisfaction with breasts (63·4 [15·8] vs 60·3 [15·4], p=0·35) and satisfaction with outcome (72·8 [19·1] vs 67·8 [16·3], p=0·19). INTERPRETATION: Taken together with our previously published findings, one-stage IBBR with ADM does not yield superior results in terms of patient-reported QOL compared with two-stage IBBR. Risks for adverse outcomes were significantly higher in the one-stage ADM group. Use of ADM for one-stage IBBM should be considered on a case-by-case basis. FUNDING: Pink Ribbon, Nuts-Ohra, and LifeCell.
RCT Entities:
BACKGROUND: There is increasing interest in the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR). Suggested advantages are that ADMs facilitate one-stage IBBR and improve aesthetic outcomes. We compared immediate one-stage ADM-assisted IBBR with two-stage IBBR (current standard of care). Our previously reported secondary endpoint showed that one-stage ADM-assisted IBBR was associated with significantly more adverse outcomes. Here, we present the primary endpoint results aiming to assess whether one-stage IBBR with ADM provides higher patient-reported quality of life (QOL) compared with two-stage IBBR. METHODS: This multicentre, open-label, randomised controlled trial (BRIOS study) was done in eight hospitals in the Netherlands. We recruited women aged older than 18 years with breast carcinoma or a genetic predisposition who intended to undergo skin-sparing mastectomy and immediate IBBR. Participants were randomly assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. Randomisation was stratified by centre and indication for surgery (oncological or prophylactic) in blocks of ten participants. The primary endpoint was patient-reported QOL, as measured with the BREAST-Q (ie, health-related QOL scales and satisfaction scales), in the modified intention-to-treat population. The study follow-up is complete. This study is registered with the Netherlands Trial Register, number NTR5446. FINDINGS: Between April 14, 2013, and May 29, 2015, we enrolled 142 women, of whom 69 were randomly assigned to receive one-stage ADM-assisted IBBR and 73 to receive two-stage IBBR. After exclusions, the modified intention-to-treat population comprised 60 patients in the one-stage group and 61 patients in the two-stage group. Of these, 48 women (mean follow-up 17·0 months [SD 7·8]) in the one-stage group and 44 women (17·2 months [SD 6·7]) in the two-stage group completed the BREAST-Q at least 1 year after implant placement. We found no significant differences in postoperative patient-reported QOL domains, including physical wellbeing (one-stage mean 78·0 [SD 14·1] vs two-stage 79·3 [12·2], p=0·60), psychosocial wellbeing (72·6 [17·3] vs 72·8 [19·6], p=0·95), and sexual wellbeing (58·0 [17·0] vs 57·1 [19·5], p=0·82), or in the patient-reported satisfaction domains: satisfaction with breasts (63·4 [15·8] vs 60·3 [15·4], p=0·35) and satisfaction with outcome (72·8 [19·1] vs 67·8 [16·3], p=0·19). INTERPRETATION: Taken together with our previously published findings, one-stage IBBR with ADM does not yield superior results in terms of patient-reported QOL compared with two-stage IBBR. Risks for adverse outcomes were significantly higher in the one-stage ADM group. Use of ADM for one-stage IBBM should be considered on a case-by-case basis. FUNDING: Pink Ribbon, Nuts-Ohra, and LifeCell.
Authors: Jens-Uwe Blohmer; Lea Beier; Andree Faridi; Christine Ankel; Barbara Krause-Bergmann; Stefan Paepke; Christine Mau; Maren Keller; Hans Joachim Strittmatter; Maria Margarete Karsten Journal: Breast Care (Basel) Date: 2020-09-16 Impact factor: 2.860
Authors: E Sewart; N L Turner; E J Conroy; R I Cutress; J Skillman; L Whisker; S Thrush; N Barnes; C Holcombe; S Potter Journal: BJS Open Date: 2021-01-08
Authors: V L Negenborn; J M Smit; R E G Dikmans; H A H Winters; J W R Twisk; P Q Ruhé; M A M Mureau; S Tuinder; Y Eltahir; N A S Posch; J M van Steveninck-Barends; R R W J van der Hulst; M J P F Ritt; M-B Bouman; M G Mullender Journal: Br J Surg Date: 2019-03-05 Impact factor: 6.939
Authors: Tim C van de Grift; Marc A M Mureau; Vera N Negenborn; Rieky E G Dikmans; Mark-Bram Bouman; Margriet G Mullender Journal: Psychooncology Date: 2020-06-05 Impact factor: 3.894