基于假体的两阶段乳房重建与即刻一期基于假体的乳房重建联合脱细胞真皮基质的比较：一项开放标签、四期、多中心、随机、对照临床试验。
Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial.
机构信息
Department of Plastic, Reconstructive, and Hand Surgery, VU University Medical Centre, Amsterdam, Netherlands; EMGO Institute for Health and Care Research Amsterdam, Amsterdam, Netherlands.
Department of Plastic, Reconstructive, and Hand Surgery, VU University Medical Centre, Amsterdam, Netherlands; EMGO Institute for Health and Care Research Amsterdam, Amsterdam, Netherlands; Alexander Monro Breast Cancer Hospital, Bilthoven, Netherlands.
出版信息
Lancet Oncol. 2017 Feb;18(2):251-258. doi: 10.1016/S1470-2045(16)30668-4. Epub 2016 Dec 22.
BACKGROUND
The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR.
METHODS
We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446.
FINDINGS
142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67-5·43, p<0·001), reoperation (3·38, 2·10-5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24-9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups.
INTERPRETATION
Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved.
FUNDING
Pink Ribbon, Nuts-Ohra, and LifeCell.
背景
目前，关于使用脱细胞真皮基质（acellular dermal matrices，ADM）在基于植入物的乳房重建（implant-based breast reconstruction，IBBR）中的应用的证据十分有限。本研究旨在前瞻性随机比较即刻行 ADM 辅助 IBBR 与行两阶段 IBBR 的安全性。
方法
本研究在荷兰的 8 家医院进行了一项开放标签、随机对照试验。符合条件的患者为年龄＞18 岁、患有乳腺癌或与乳腺癌相关的基因突变、拟行保留皮肤的乳房切除术并即刻行 IBBR 的女性。采用电子方式进行随机分组，按照中心和 10 例为一组的分组进行分层，以达到大致平衡的分组。患者被随机分配至即刻行 ADM（Strattice，LifeCell，Branchburg，NJ，美国）辅助的一阶段 IBBR 组或两阶段 IBBR 组。主要终点为生活质量，通过不良结局的发生来评估安全性。采用逻辑回归和广义估计方程进行意向性治疗分析。本研究在荷兰临床试验注册中心（Nederlands Trial Register）注册，编号为 NTR5446。
结果
2013 年 4 月 14 日至 2015 年 5 月 29 日，共有 142 名女性入组，其中 59 名（91 侧乳房）患者被分配至即刻行 ADM 辅助的一阶段 IBBR 组，62 名（92 侧乳房）患者被分配至两阶段 IBBR 组。与两阶段 IBBR 相比，即刻行 ADM 辅助的一阶段 IBBR 每侧乳房的手术并发症（粗比值比 3.81，95%CI 2.67-5.43，p＜0.001）、再次手术（3.38，2.10-5.45，p＜0.001）和植入物、ADM 或两者均移除（8.80，8.24-9.40，p＜0.001）的风险更高。即刻行 ADM 辅助的一阶段 IBBR 组中 91 侧乳房有 26 侧（29%）发生严重（3 级）不良事件，两阶段 IBBR 组中 92 侧乳房有 5 侧（5%）发生严重不良事件。两组中轻度至中度不良事件的发生频率相似。
结论
即刻行 ADM 辅助的一阶段 IBBR 与不良事件相关，应谨慎考虑。需要进一步了解患者选择、风险因素以及手术和术后处理等方面。
研究资金
Pink Ribbon、Nuts-Ohra 和 LifeCell。
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