Evaluating the potential of relapse-free survival as a surrogate for overall survival in the adjuvant therapy of melanoma with checkpoint inhibitors
Evaluating the potential of relapse-free survival as a surrogate for overall survival in the adjuvant therapy of melanoma with checkpoint inhibitors
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DOI：
10.1016/j.ejca.2020.07.011
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发表时间：
2020-09-01
影响因子：
8.4
通讯作者：
Kotapati, Srividya
中科院分区：
文献类型：
--
作者：
Coart, Elisabeth;Suciu, Stefan;Kotapati, Srividya
前言：最近黑色素瘤辅助治疗的变化引起了人们对证实无复发生存期(RFS)作为总生存期(OS)替代物的兴趣。方法：我们使用荟萃分析框架，使用来自欧洲癌症研究和治疗组织(EORTC)18071年的伊匹单抗试验的个体患者数据和发表的其他辅助试验的结果来探讨这一问题。结果：在中位5.3年的随访期中，个体患者数据分析结果显示RFS与OS在患者水平上有很强的相关性(r=0.84；95%可信区间[CI]：0.82-0.87)和试验水平的中等相关性(R-2=0.59；95%可信区间：0.08-1.00)。结论：将EORTC 18071结果添加到使用其他试验的已发表结果进行回归分析时，以前在干扰素试验中观察到的试验水平相关性似乎保持不变。在这种情况下，需要更多的佐剂试验数据来确认RFS和OS之间的关联强度。(C)2020年由爱思唯尔有限公司出版。
Introduction: Recent changes in the adjuvant treatment of melanoma have raised interest in confirming relapse-free survival (RFS) as a surrogate for overall survival (OS).Methods: We explore this issue with the meta-analytic framework, using individual patient data from the European Organisation for Research and Treatment of Cancer (EORTC) 18071 trial of ipilimumab and published results from other adjuvant trials.Results: The individual patient data analysis results at a median follow-up of 5.3 years showed a strong association between RFS and OS at the patient level (r = 0.84; 95% confidence interval [CI]: 0.82-0.87) and a moderate association at the trial level (R-2 = 0.59; 95% CI: 0.08-1.00).Conclusions: The trial-level association previously observed in interferon-based trials appeared to be maintained when the EORTC 18071 results were added to a regression analysis using published results from other trials. More data from adjuvant trials are required to confirm the strength of association between RFS and OS in this setting. (c) 2020 Published by Elsevier Ltd.