Negenborn VL, et al. - Researchers presented the primary endpoint results evaluating if one-stage implant-based breast reconstruction (IBBR) with acellular dermal matrices (ADMs) allows better patient-reported quality of life (QOL) vs two-stage IBBR, given that one-stage ADM-assisted IBBR was associated with significantly more adverse outcomes in previous findings. In combination with the previously published findings, superior results in terms of patient-reported QOL were not seen with one-stage IBBR vs two-stage IBBR. In the one-stage ADM group, significantly higher risks for adverse outcomes were seen. For one-stage IBBM, use of ADM should be considered on a case-by-case basis.

Methods

• Experts conducted this multicenter, open-label, randomized controlled trial (BRIOS study) in eight hospitals in the Netherlands.
• They recruited women older than 18 years old with breast carcinoma or a genetic predisposition who intended to undergo skin-sparing mastectomy and immediate IBBR.
• They randomly assigned the participants to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR.
• Authors stratified the randomization by center and indication for surgery (oncological or prophylactic) in blocks of 10 participants.
• In the modified intention-to-treat population, the primary endpoint was patient-reported QOL, as measured with the BREAST-Q (ie, health-related QOL scales and satisfaction scales).

Results

• As per data, they enrolled 142 women between April 14, 2013 and May 29, 2015, of whom 69 were randomized to receive one-stage ADM-assisted IBBR and 73 to receive two-stage IBBR.
• The modified intention-to-treat population, after exclusions, had 60 patients in the one-stage group and 61 patients in the two-stage group.
• Findings suggested that out 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.
• They did not note any 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).