Progression-Free Survival as a Surrogate for Overall Survival in Advanced/Recurrent Gastric Cancer Trials: A Meta-Analysis
Progression-Free Survival as a Surrogate for Overall Survival in Advanced/Recurrent Gastric Cancer Trials: A Meta-Analysis
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DOI：
10.1093/jnci/djt269
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发表时间：
2013-11-01
影响因子：
10.3
通讯作者：
Buyse, Marc
中科院分区：
文献类型：
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作者：
Paoletti, Xavier;Oba, Koji;Buyse, Marc
评估晚期/复发性胃癌化疗疗效的传统终点是总生存期（OS），但OS需要长期随访。我们研究了无进展生存期 (PFS) 是否可以有效替代 OS。使用 GASTRIC 荟萃分析中的个体患者数据，通过终点之间的相关性以及终点治疗效果之间的相关性来评估 PFS 的替代性。还评估了基于 PFS 的预测的外部验证。对 20 项随机试验中 4069 名患者的个体数据进行了分析。 PFS 和 OS 之间的等级相关系数为 0.853（95% 置信区间 [CI] = 0.852 至 0.854）。 PFS 和 OS 治疗效果之间的 R-2 为 0.61（95% CI = 0.04 至 1.00）。 PFS 和 OS 的治疗效果仅中度相关，我们无法确认 PFS 作为晚期/复发性胃癌 OS 替代终点的有效性。
The traditional endpoint for assessing efficacy of chemotherapies for advanced/recurrent gastric cancer is overall survival (OS), but OS requires prolonged follow-up. We investigated whether progression-free survival (PFS) is a valid surrogate for OS. Using individual patient data from the GASTRIC meta-analysis, surrogacy of PFS was assessed through the correlation between the endpoints and through the correlation between the treatment effects on the endpoints. External validation of the prediction based on PFS was also evaluated. Individual data from 4069 patients in 20 randomized trials were analyzed. The rank correlation coefficient between PFS and OS was 0.853 (95% confidence interval [CI] = 0.852 to 0.854). The R-2 between treatment effects on PFS and on OS was 0.61 (95% CI = 0.04 to 1.00). Treatment effects on PFS and on OS were only moderately correlated, and we could not confirm the validity of PFS as a surrogate endpoint for OS in advanced/recurrent gastric cancer.