重新分析尿癌化学免疫疗法试验与差异审查
Tomer Meirson1,2,3, Jonathan Ofer1, Noa Zimhony-Nissim1
1Davidoff Cancer Center, Rabin Medical Center, Petach Tikvah, Israel.
JAMA network open
|January 22, 2025
概括
晚期泌尿腺癌临床试验中的差异性审查可能解释了PD-1/PD-L1抑制剂与化疗相结合的不一致结果. 这种现象被称为感知劣势审查,影响了试验解释.
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:
- 三个第三阶段试验 (IMvigor130,KEYNOTE-361,CheckMate901) 评估了PD-1/PD-L1抑制剂加上化疗与单独化疗用于晚期泌尿腺癌.
- 报告了不一致的整体生存 (OS) 益处,只有CheckMate901显示出显著的OS优势.
研究的目的:
- 调查差异性审查作为这些试验中相互矛盾的结果的潜在解释.
- 分析审查失衡对报告的治疗效果的影响.
主要方法:
- 一项比较有效性研究,涉及对IMvigor130,KEYNOTE-361和CheckMate901.1.的数据进行审查分析.
- 卡普兰-梅尔曲线被用来计算审查率,对对照组过度审查进行了敏感性分析.
主要成果:
- 在仅进行化疗的KEYNOTE-361和CheckMate901手臂中观察到过度审查 (> 30%).
- 在调整后,在这些试验中,组合治疗对PFS的益处并不显著.
- 在CheckMate901的OS分析中,差异性审查导致敏感性分析后的尼沃卢马布加化疗的观察到的OS益处丧失.
结论:
- 不同的审查,可能是由于患者寻求替代治疗 ("感知劣势审查"),混了KEYNOTE-361和CheckMate901.1中结果的解释.
- 这种审查不平衡可能会危及试验随机化,并导致有偏见的比较,影响组合疗法的感知有效性.
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