在一线先进或复发性子宫内膜癌中,中间终点,无进展生存率和整体生存率之间的关联
Jamie Garside1, Qin Shen2, Bernd Westermayer3
1Department of Value Evidence and Outcomes, GSK, London, United Kingdom.
Clinical therapeutics
|September 9, 2023
概括
无进展生存期 (PFS) 和进展时间 (TTP) 与晚期子宫内膜癌的总生存期 (OS) 有很强的相关性. 这些指标可以帮助预测临床试验的长期结果,当操作系统数据尚未成熟时.
科学领域:
- 妇科瘤学 妇科瘤学
- 临床试验设计 临床试验设计
- 生物统计学 生物统计学
背景情况:
- 晚期/复发的子宫内膜癌带来了重大挑战,长期结果不佳.
- 总生存率 (OS) 数据的成熟缓慢,需要在临床研究中使用代用终点.
- 无进展生存率 (PFS) 和进展时间 (TTP) 是经常使用的替代终点.
研究的目的:
- 评估PFS/TTP和OS在先进/复发性子宫内膜癌的第一线治疗中的相关性.
- 为了确定PFS/TTP对长期OS结果的预测值.
- 为临床决策提供有关使用PFS/TTP作为替代终点的信息.
主要方法:
- 通过系统文献审查识别的2/3期随机对照试验的元分析.
- 使用斯皮尔曼和皮尔森系数评估代孕强度的相关性分析.
- 权重线性回归来量化PFS/TTP和OS之间的关系.
主要成果:
- 来自15项研究的数据显示PFS/TTP和OS之间存在强烈的正相关性 (斯皮尔曼:0.83-0.90;皮尔森:0.86-0.93).
- 增加10%的PFS/TTP概率与增加9.3%至13.3%的OS概率有关.
- 敏感性分析证实了PFS/TTP和OS之间的强有力的关联,解释了研究间的异质性.
结论:
- 在一线先进/复发性子宫内膜癌试验中,PFS/TTP作为长期OS的可靠预测剂.
- 这些发现支持使用PFS/TTP作为替代终点,为卫生当局和临床医生提供有价值的见解.
- 在PFS/TTP的改进可能会转化为更好的操作系统,一旦成熟的数据变得可用.
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