无进展生存率,无疾病生存率和其他瘤学复合终点:需要改善报告
Anushka Walia1, Jordan Tuia2, Vinay Prasad2
1School of Medicine, University of California, San Francisco, San Francisco, CA, USA. anushka.walia@ucsf.edu.
Nature reviews. Clinical oncology
|October 12, 2023
概括
瘤学试验中的复合终点提高了统计能力,但缺乏明确的定义. 对组件事件的透明报告对于准确解释治疗效益至关重要.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 复合终点如无进展生存率 (PFS) 和无疾病生存率 (DFS) 在瘤学研究中很常见.
- 这些措施将多个事件 (例如,瘤再生,新病变,死亡) 结合到一个单一的时间到事件结果中.
- 虽然提供了统计上的优势,但复合终点存在重大局限性.
研究的目的:
- 突出在瘤学试验中复合终点内报告组件事件的缺陷.
- 讨论使用复合端点的优势和挑战.
- 倡导对组件事件分解进行透明报告,以准确解释试验.
主要方法:
- 对50项使用无进展生存作为结果的瘤学研究的综述.
- 分析了五个主要瘤学期刊上发表的研究.
- 检查复合终点的定义和报告实践.
主要成果:
- 在关键瘤学试验中,复合结果测量经常被用作主要终点.
- 复合终点的定义往往缺乏标准化,阻碍了跨试验的比较.
- 发表的瘤学研究中很少提供有关组件事件的具体细分信息.
结论:
- 对复合终点缺乏透明的报告使得临床试验结果的解释变得复杂.
- 组件事件定义和临床意义的变化会影响治疗疗效的评估.
- 在瘤学研究中,对组件事件进行标准化和透明的报告至关重要,以确保对治疗益处的准确评估.
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