对直肠癌的器官保护 (GRECCAR 2):一个前性,随机的,开放的,多中心的,第三阶段试验
Eric Rullier1, Philippe Rouanet2, Jean-Jacques Tuech3
1Department of Colorectal Surgery, Haut-Lévèque Hospital, Pessac, CHU Bordeaux, France.
Lancet (London, England)
|June 12, 2017
概括
在直肠癌治疗后,器官的保存表明局部切除并没有优于全间直肠切除. 在局部切除组中完成手术增加了患病率,否定了潜在的益处.
科学领域:
- 癌症学
- 外科瘤学
- 临床试验
背景情况:
- 对于新辅助化疗反应良好的直肠癌患者来说,器官保存是一种方法.
- 它的目的是避免直肠切除的病率和副作用.
- 这项研究比较了下直肠癌化学放射治疗后的局部切除 (LE) 与全直肠切除 (TME).
研究的目的:
- 为了比较局部切除与全腹腔切除的疗效和安全性.
- 评估低直肠癌患者在化疗后获得良好临床反应的结局.
主要方法:
- 一个前性的,随机的,开放的,多中心的第三阶段试验.
- 145名患有下直肠癌的良好临床反应者被随机分为LE或TME.
- 主要终点:2年死亡,复发,发病率和副作用的综合结果.
主要成果:
- 56%的LE群体和48%的TME群体在2年后出现了一种或多种主要结果事件.
- 在复合结果或其组件中没有观察到LE和TME之间的显著差异.
- 局部切除并没有显示出优于全腹腔切除的效果.
结论:
- 这项研究未能证明局部切除对全间直肠切除的优势.
- 在LE组中完成TME的高率可能增加了病率,并影响了LE的益处.
- 改善患者选择可以提高器官保存策略.
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