基于下确界和上确界对数秩检验统计量的新的晚期强调和组合测试及其在肿瘤学试验中的应用。
New late-emphasis and combination tests based on infimum and supremum logrank statistics with application in oncology trials.
发表日期:2023 Mar 31
作者:
Jean Marie Boher, Thomas Filleron, Pierre Bunouf, Richard J Cook
来源:
STATISTICS IN MEDICINE
摘要:
免疫治疗癌症临床试验通常包括一个初始期,此期间患者接受治疗,无明显的治疗效果,随后会出现一段期间,在此期间有效的治疗将降低事件发生的危险率。这种治疗的效应与比例风险假设不相容,因此在替代效应测量和框架测试的开发方面进行了大量的工作。我们考虑基于早期和晚期重点下确界和上确界logrank统计数据的个体和组合测试,描述了它们如何实施,并通过模拟研究评估其性能。通过这项工作和举例应用,我们得出结论,这类检验统计量为评估涉及免疫治疗的癌症临床试验中的治疗效果提供了一个新而强大的框架。© 2023 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.
Immunotherapy cancer clinical trials routinely feature an initial period during which the treatment is given without evident therapeutic benefit, which may be followed by a period during which an effective therapy reduces the hazard for event occurrence. The nature of this treatment effect is incompatible with the proportional hazards assumption, which has prompted much work on the development of alternative effect measures of frameworks for testing. We consider tests based on individual and combination of early- and late-emphasis infimum and supremum logrank statistics, describe how they can be implemented, and evaluate their performance in simulation studies. Through this work and illustrative applications we conclude that this class of test statistics offers a new and powerful framework for assessing treatment effects in cancer clinical trials involving immunotherapies.© 2023 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.