Late divergence of survival curves in cancer immunotherapy trials: interpretation and implications
Late divergence of survival curves in cancer immunotherapy trials: interpretation and implications
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DOI：
10.1007/s00262-013-1458-y
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发表时间：
2013-10-01
影响因子：
5.8
通讯作者：
Strannegard, Orjan
中科院分区：
文献类型：
--
作者：
Thoren, Fredrik B.;Anderson, Harald;Strannegard, Orjan
在成功的癌症免疫治疗试验中，治疗患者和对照组的生存曲线出现晚期差异是很常见的。虽然晚期生存曲线差异可能是由于治疗的延迟作用引起的，但它也可能与治疗的早期效果有关。我们认为，晚期生存差异通常反映了疾病进展相对缓慢的患者的治疗的特定益处。延迟生存曲线偏离的发生对免疫治疗试验的统计分析具有重要意义。因此，它导致非比例风险比，使常用的统计检验，如洛格兰克检验，不是最优的。因此，建议免疫治疗试验的统计分析主要应该基于在预先指定的、固定的、晚时间点或之后比较生存曲线的测试。
Late divergence of survival curves of treated patients and controls is commonly seen in successful cancer immunotherapy trials. Although late survival curve divergence may be caused by a delayed action of therapy, it may also be related to early effects of the treatment. We suggest that late survival divergence most often reflects a specific benefit of therapy for patients who suffer from a comparatively slow progression of disease. The occurrence of delayed survival curve divergence has important implications for the statistical analysis of immunotherapy trials. Thus, it leads to non-proportional hazard ratios that make commonly used statistical tests, e.g., the logrank test, suboptimal. It is therefore suggested that the statistical analysis of immunotherapy trials primarily should be based on a test that compares the survival curves at or after a prespecified, fixed, late time point.