Dutch Quality-of-Life Study With One- vs Two-Stage Breast Reconstruction in Skin-Sparing Mastectomy


Key Points

  • No significant differences in QOL or satisfaction were observed with the one-stage vs two-stage procedure.
  • The one-stage procedure was associated with more adverse outcomes in a prior safety analysis.

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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.