替代终点对扩大阶段小细胞肺癌整体存活率的元分析
1University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, USA.
ESMO open
|October 16, 2025
概括
无进展生存率 (PFS) 在一线小细胞肺癌 (SCLC) 试验中强烈预测整体生存率 (OS),包括免疫治疗. 然而,整体反应率 (ORR) 和疾病控制率 (DCR) 并不能可靠地预测SCLC的结果.
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:
- 总体应答率 (ORR),疾病控制率 (DCR) 和无进展生存率 (PFS) 是通常用于总体生存率 (OS) 的替代终点.
- 这些替代品在预测小细胞肺癌 (SCLC) 的生存系统中的可靠性尚未得到充分证实.
研究的目的:
- 系统地评估ORR,DCR和PFS作为SCLC中OS的替代终点的有效性.
- 评估不同治疗线和环境中这些终点之间的相关性.
主要方法:
- 根据PRISMA指南,对MEDLINE,Embase,Cochrane和ClinicalTrials.gov (2014-2024) 进行了系统的文献搜索.
- 从23个随机的III期SCLC试验 (10,340名患者) 中提取了数据.
- 使用权重线性回归和皮尔森相关性分析来评估代理终点和OS之间的关联.
主要成果:
- 无进展生存期 (PFS) 与一线SCLC (r=0.77,P<0.001) 和一线免疫疗法设置 (r=0.80,P=0.006) 的总生存期 (OS) 有着强烈的相关性.
- 总体应答率 (ORR) 和疾病控制率 (DCR) 在一线或二线设置中与OS无关.
- 在第二行设置中,DCR与PFS相关 (r=-0.84,P=0.01),但与OS无关.
结论:
- 无进展生存率 (PFS) 是临床上有价值和可靠的替代终点,用于第一线SCLC的整体生存率 (OS),包括化疗免疫治疗.
- 总体反应率 (ORR) 和疾病控制率 (DCR) 不是SCLC长期结果的可靠预测指标.
- 在未来SCLC临床试验的设计和解释中,PFS应优先考虑ORR和DCR.
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