在先进癌症的免疫疗法试验中进行审查. 一个系统审查和一个元研究
Filippo Vitale1, Fabio Salomone1, Massimo Di Maio2
1Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Sergio Pansini 5, Naples, Italy.
Journal of the National Cancer Institute
|August 26, 2025
概括
针对免疫检查点抑制剂 (ICI) 的随机对照试验 (RCT) 的审查率有显著差异. 在试验早期的对照组中发生了更多的审查,而实验组后来显示了更多的审查,影响了生存结果的解释.
科学领域:
- 癌症学
- 临床试验方法
- 生物统计学
背景情况:
- 信息审查对临床试验结果的解释产生重大影响.
- 了解免疫检查点抑制剂 (ICI) 试验中的审查率对于准确的结果评估至关重要.
研究的目的:
- 在评估免疫检查点抑制剂 (ICI) 的随机对照试验 (RCT) 中调查和量化审查率.
- 在癌症试验中比较对照组和实验组之间的审查模式.
主要方法:
- 在2023年12月发布的晚期癌症中对ICI进行系统的RCT搜索.
- 从Kaplan-Meier曲线中提取特定间隔的无进展生存 (PFS) 和总生存 (OS) 的审查率 (T1,Tm,T2).
- 控制组 (C) 和实验组 (E) 之间的审查率 (wΔC-E) 的加权差异的计算.
主要成果:
- 在140个选定的试验中,只有37. 8% (PFS) 和39. 2% (OS) 的审查数据可用.
- 对于PFS和OS,在开始的对照组 (T1) 观察到更高的审查率.
- 实验组在试验结束时 (T2) 对PFS和OS的审查率都较高.
- 与双盲RCT相比,开放RCT在T1的对照组中显示出更高的审查率.
结论:
- 许多ICIRCT没有完全报告审查数据.
- 审查模式是动态的,对照组的初始率较高,实验组的后期增长.
- 需要进一步研究以充分理解这些审查模式对ICI试验生存结果的影响.
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