在NSCLC患者的试验和观察队列中,基于反应和进展的终点
Yichen Lu1, Spencer S Langerman1, Emily McCain1
1Flatiron Health, New York City, New York.
JAMA network open
|May 3, 2024
概括
在非小细胞肺癌患者的临床试验和观察队列中,反应和进展终点相似. 这为临床决策和未来研究验证了观察数据.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 现实世界的证据.
背景情况:
- 固体瘤反应评估标准 (RECIST) 是临床试验中的标准,但不是常规护理,限制了它们在观察性研究中的使用.
- 临床医生定响应措施得到了验证,但缺乏与临床试验数据的比较,这阻碍了它们在决策中的应用.
研究的目的:
- 在非小细胞肺癌 (NSCLC) 患者的临床试验和观察队伍中比较基于反应和进展的终点.
- 评估观察数据的可靠性,用于临床决策.
主要方法:
- 使用IMpower132试验数据和电子健康记录 (EHR) 衍生数据库的回顾性队列研究.
- 在加权的观察和试验队列之间比较反应率,反应持续时间和无进展生存率.
主要成果:
- 临床试验和加权观察队列之间的反应和进展终点是可比的.
- 来自EHR的响应率数量上高于客观响应率,受影响的是包括没有响应评估的患者.
结论:
- 基于反应和进展的终点在临床试验和加权观察队列之间是相似的,这增加了对观察数据可靠性的信心.
- 结果支持使用观察数据进行临床决策,并为未来的研究提供有关EHR衍生反应率的信息.
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