随机对照试验的设计,以估计从多种癌症检测查减少的癌症死亡率
Ping Hu1, Philip C Prorok1, Hormuzd A Katki2
1Division of Cancer Prevention, Department of Health and Human Services, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Journal of the National Cancer Institute
|October 9, 2024
概括
多种癌症检测 (MCD) 测试显示,有望减少癌症死亡率. 大型随机对照试验 (RCT) 可以检测出10%的癌症死亡率降低,大多数死因是肺癌.
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:
- 确定多种癌症检测 (MCD) 测试的救命潜力需要严格的随机对照试验 (RCT).
- 这项研究旨在通过估计潜在的癌症死亡结果,为未来的MCDRCT的设计提供信息.
研究的目的:
- 为了估计癌症死亡率的减少,所需的样本大小和假设的MCDRCT的统计能力.
- 评估各种RCT和MCD测试参数对研究结果的影响.
主要方法:
- 使用了Hu-Zelen模型,这是一种验证的工具,以前用于国家肺部查试验 (NLST).
- 模拟RCT涉及10万名参与者,每只手臂接受9种癌症类型的5次年度查.
- 评估了不同查频率,参与者人口统计和MCD测试性能特征的评估结果.
主要成果:
- 一个基准病例RCT设计表明87%-89%的功率来检测9%-10%的死亡率降低超过7-9年.
- 肺癌占预防死亡的大多数 (64%-66%),其次是结直肠癌 (8%-10%).
- 观察到在个别非肺癌,非结肠直肠癌部位检测死亡率降低的功率有限.
结论:
- 大规模的MCDRCT预计将有89%的功率来检测7-9年内~10%的癌症死亡率减少.
- 对于MCDRCT,所需查的估计数量 (NNS) 相当于哺乳镜查.
- 虽然肺癌占据了预防死亡的主导地位,但其他癌症的贡献是有意义的,尽管孤立它们的特定死亡率降低需要进一步研究或更高风险人群.
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