Time to Progression as a Surrogate Marker for Overall Survival in Patients with Advanced Non-small Cell Lung Cancer
Time to Progression as a Surrogate Marker for Overall Survival in Patients with Advanced Non-small Cell Lung Cancer
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DOI：
10.1097/jto.0b013e3181989bd2
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发表时间：
2009-03-01
影响因子：
20.4
通讯作者：
Tanimoto, Mitsune
中科院分区：
文献类型：
--
作者：
Hotta, Katsuyuki;Fujiwara, Yoshiro;Tanimoto, Mitsune
目的：随着用于晚期非小细胞肺癌的活性化合物越来越多，评估替代终点是否可以替代随机试验中的生存期以快速有效地评估疗效是有用的。我们通过文献调查研究了总生存期和进展时间（TTP）差异之间的关系。方法：我们使用54项III期试验或一线化疗的中位TTP （MTTP）和中位生存时间（MST）进行多元线性回归分析，涉及23,457例晚期非小细胞肺癌患者。每项试验的MST比被定义为研究组与参考组的MST比。MTTP比率的定义类似。结果：尽管在多元回归模型中MTTP比率是影响MST比率的独立因素（p < 0.01），但在整体队列（R(2) = 0.33）和各种试验设置（R(2) = 0.16 0.51）中，MST与MTTP比率之间的关联程度仅为中等。这意味着MTTP比率可能占MST比率方差的不到一半。结论：TTP可能作为一种替代标志物，但可能不是第一fine设置的最终选择。
Purpose: With the increasing number of active compounds available for advanced non-small cell lung cancer, it is useful to evaluate whether surrogate end points can replace Survival in randomized trials for the rapid and efficient assessment of efficacy. We examine the association between differences in overall survival and time to progression (TTP) using a literature survey.Methods: We used median TTP (MTTP) and median survival time (MST) from 54 phase III trials or first-line chemotherapy involving 23,457 advanced non-small cell lung cancer patients in a multiple linear regression analysis. The MST ratio in each trial was defined as the ratio of MST in the investigational arm to that in the reference arm. The MTTP ratio was defined similarly.Results: The degree of the association between the MST and MTTP ratios was only moderate both in the overall cohort (R(2) = 0.33) and various trial settings (R(2) = 0.16 0.51), although the MTTP ratio was an independent factor influencing the MST ratio in the multiple regression model (p < 0.01). This means that the MTTP ratio could account for less than half of the variance in the MST ratio.Conclusions: The TTP potentially acts as a Surrogate Marker, but may not be still a definitive alternative in the first-fine setting.