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在CART临床试验中不一致的报告和时间到事件终点的定义:一项审查
Connor B Grady1, Yimei Li2, Shannon L Maude3
1Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.
Transplantation and cellular therapy
|November 27, 2024
概括
化学抗原受体T细胞 (CAR T) 治疗试验显示对时间到事件终点的报告不一致,阻碍了比较. 标准化总生存期和无进展生存期的定义对于准确的临床益处评估至关重要.
科学领域:
- 免疫治疗是一种免疫疗法.
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 化学抗原受体T细胞 (CAR T) 疗法是癌症治疗中的一个快速发展的领域.
- 时间到事件 (TTE) 终点对于评估CAR T疗效至关重要,但定义在不同研究中存在很大差异.
研究的目的:
- 总结CAR T临床试验中TTE终点报告的异质性和完整性.
- 确定影响报告质量的因素,如研究阶段和出版年份.
主要方法:
- 2008年1月至2023年1月在PubMed.上发表的CAR T试验的系统审查.
- 抽象和总结TTE终点定义 (时间来源,事件,审查) 和报告完整性.
- 分析报告的完整性,按研究阶段,出版年和期刊影响因素划分.
主要成果:
- 分析了116篇出版物,其中总生存率 (OS) 和无进展生存率 (PFS) 是最常见的TTEs.
- 对TTE定义的完整报告在所有终点上都很差,特别是OS (32%),PFS (24%) 和响应持续时间 (DOR) (25%).
- 在早期出版物,较低影响因子期刊和I期试验中,报告质量较低,TTE定义具有显著的变化.
结论:
- 在CAR T试验中,TTE终点定义存在实质性的异质性和不完整性.
- 这种变异性阻碍了对结果的准确解释和试验间的对比.
- 标准化的TTE报告,包括时间起源,事件和审查,对于评估临床益处至关重要.
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