Progression-free survival as a surrogate endpoint of overall survival in patients with metastatic colorectal cancer.
Progression-free survival as a surrogate endpoint of overall survival in patients with metastatic colorectal cancer.
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DOI：
10.2147/ott.s151276
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发表时间：
2018
影响因子：
4
通讯作者：
Dieli F
中科院分区：
文献类型：
--
作者：
Cicero G;De Luca R;Dieli F
在许多旨在评估抗癌治疗疗效的临床试验中，总生存期（OS）经常被用作主要终点，尽管它有几个弱点。本研究评估了无进展生存期（PFS）作为转移性结直肠癌（MCRC）患者OS的潜在替代终点在前三线治疗中的作用。120例MCRC患者参加了这项研究。评估一线、二线和三线治疗的中位PFS和OS。分析进展时间与OS的相关性。三线治疗的中位PFS分别为8.5个月、5个月和3个月。中位OS为32.4个月。发现一线治疗Folfox-avastin的PFS和OS之间存在适度的相关性。二线治疗获得了类似的数据。然而，在三线治疗期间，PFS和OS之间没有相关性。回归分析显示PFS可预测OS。简而言之，一线和二线治疗的PFS可以作为MCRC患者OS的替代终点。
In many clinical trials designed to assess the efficacy of anticancer treatments, overall survival (OS) is often used as a primary endpoint despite its several points of weakness. This study evaluated the role of progression-free survival (PFS) in the first three lines of treatment as a potential surrogate endpoint of OS in patients with metastatic colorectal cancer (MCRC). One hundred and twenty patients with MCRC were enrolled in this study. The median PFS of the first-, second-, and third-lines of treatment and the OS were evaluated. The correlation between the time to progression and the OS was analyzed. The median PFS of the three lines of treatment were 8.5, 5, and 3 months, respectively. The median OS was 32.4 months. A modest correlation was found between the PFS to the first-line treatment with Folfox–avastin and OS. Similar data were obtained with the second-line treatment. However, no correlation was found between the PFS and OS during the third-line treatment. The regression analysis revealed that PFS is predictive of OS. In brief, the PFS of the first- and second-lines of treatment could be a good candidate as a surrogate endpoint of OS in patients with MCRC.