Dutch Quality-of-Life Study With One- vs Two-Stage Breast Reconstruction in Skin-Sparing Mastectomy
In a Dutch study reported in The Lancet Oncology, Negenborn et al found no differences in quality of life (QOL) between women receiving one-stage implant-based breast reconstruction (IBBR) with an acellular dermal matrix (ADM) vs standard two-stage IBBR. A previously reported safety analysis from the trial indicated that one-stage ADM-IBBR was associated with significantly more adverse outcomes.
Study Details
In the multicenter open-label trial, 121 women (modified intent-to-treat population) with breast carcinoma or a genetic predisposition who intended to undergo skin-sparing mastectomy and immediate IBBR were randomized between April 2013 and May 2015 to receive one-stage ADM-IBBR (n = 60) or standard two-stage IBBR (n = 61).
The primary endpoint was patient-reported QOL assessed by the BREAST-Q (0–100 domain scales).
Patient-Reported Outcomes
A total of 48 women (mean follow-up = 17.0 months) in the one-stage group and 44 women (mean follow-up = 17.2 months) in the two-stage group completed the BREAST-Q at least 1 year after the implant procedure. No significant differences between groups were found for postoperative QOL domains, including physical well-being (one-stage group mean = 78.0 vs two-stage group mean = 79.3, P = .60), psychosocial well-being (72.6 vs 72.8, P = .95), and sexual well-being (58.0 vs 57.1, P = .82). No significant differences were found in patient-reported satisfaction domains, including satisfaction with breasts (63.4 vs 60.3, P = .35) and satisfaction with outcome (72.8 vs 67.8, P = .19).
The investigators concluded, “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.”
The study was funded by Pink Ribbon, Nuts-Ohra, and LifeCell.
Margriet Gezina Mullender, PhD, of Amsterdam UMC, Vrije Universiteit, is the corresponding author for The Lancet Oncology article.
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