辅助化疗与结直肠癌患者的观察:一项随机化研究
1, Richard Gray, Jennifer Barnwell
1Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Lancet (London, England)
|December 18, 2007
概括
用黄和叶酸辅助化疗改善了II期结直肠癌患者的存活率. 这种治疗降低了死亡和复发的风险,提供了小但显著的生存益处.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 胃肠道瘤学 胃肠道瘤学
背景情况:
- 在QUASAR试验中,研究了辅助化疗在低风险结直肠癌患者的疗效.
- 在此患者群体中,辅助化疗的适应性先前尚不清楚.
研究的目的:
- 确定辅助化疗在患有复发风险较低的结直肠癌患者的生存益处.
- 评估任何观察到的生存优势的持续时间.
主要方法:
- 3239名II期结直肠癌患者被随机分配给接受甲和叶酸化疗或观察.
- 治疗方案包括不同的静脉注射黄和L-folinic酸的时间表,在前几年有或没有levamisole.
- 主要终点是全因死亡率,根据治疗意图进行分析.
主要成果:
- 与观察相比,化疗显著降低了死亡 (0.82;p=0.008) 和复发 (0.78;p=0.001) 的相对风险.
- 随访时间中位数为5.5年,化疗组有311人死亡,观察组有370人死亡.
- 治疗疗效在各个子组中是一致的,包括瘤部位,阶段,性别和年龄.
结论:
- 用甲和叶酸进行辅助化疗可以改善II期结肠直肠癌患者的生存率.
- 绝对生存率的改善是适度的,估计在5年内3.6%.
- 这项研究支持在选择的II期结肠直肠癌患者中使用这种化疗方案.
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