论文标题
在预期生存曲线的预期延迟分离的设置中，分层的适度加权对数秩测试
Stratified modestly-weighted log-rank tests in settings with an anticipated delayed separation of survival curves
论文作者
论文摘要
生存曲线的延迟分离是免疫肿瘤学验证性研究的常见。近年来，已经提出了许多旨在有效捕获潜在长期生存改善的新型统计方法。但是，绝大多数人不考虑分层，这是一个主要限制，考虑到大多数（如果不是全部）大型验证性研究目前采用分层的主要分析。在本文中，我们结合了最近提出的加权对数秩检验，这些测试旨在在生存曲线的延迟分离下正常工作，并通过基线变量进行分层。目的是提高测试的效率时，当分层变量对生存具有高度的预后。由于有许多潜在的方法可以结合两种技术，因此我们比较了广泛的模拟研究中的几种可能性。我们还追溯地应用了两项随机临床试验。
Delayed separation of survival curves is a common occurrence in confirmatory studies in immuno-oncology. Many novel statistical methods that aim to efficiently capture potential long-term survival improvements have been proposed in recent years. However, the vast majority do not consider stratification, which is a major limitation considering that most (if not all) large confirmatory studies currently employ a stratified primary analysis. In this article, we combine recently proposed weighted log-rank tests that have been designed to work well under a delayed separation of survival curves, with stratification by a baseline variable. The aim is to increase the efficiency of the test when the stratifying variable is highly prognostic for survival. As there are many potential ways to combine the two techniques, we compare several possibilities in an extensive simulation study. We also apply the techniques retrospectively to two recent randomized clinical trials.
