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首页> 外文期刊>Memo - Magazine of European medical oncology >Challenges with overall survival as an endpoint for efficacy assessment in first line metastatic breast cancer randomized controlled clinical trials and the investigation of truncated overall survival as an alternative endpoint
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Challenges with overall survival as an endpoint for efficacy assessment in first line metastatic breast cancer randomized controlled clinical trials and the investigation of truncated overall survival as an alternative endpoint

机译：一线转移性乳腺癌随机对照临床试验中以总生存为终点进行疗效评估的挑战以及作为替代终点的截短总生存的研究

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Background Overall survival (OS) remains the gold standard to assess treatment benefit in randomized controlled clinical trials (RCT) of advanced cancer. In first line metastatic breast cancer (1 L MBC) where survival typically is several years instead of months, it is increasingly seen that OS-treatment effects dilute over time, with later line therapies strongly influencing OS analyses. We investigate truncated OS (i.e., truncating deaths and follow-up beyond a certain time point from randomization) as a potential alternative endpoint to OS. Methods We reanalyze data from two RCTs in 1L MBC to illustrate how OS results can be driven by early treatment effects. We flexibly model the hazard ratio (HR) according to time since randomization. We conduct simulations to characterize the impact of number of events, sample-size, and recruitment on the power of the log-rank test for OS and for truncated OS considering truncation at 12, IB, or 24 months in presence of non-proportional hazards (non-PH).
机译：背景技术总生存（OS）仍然是评估晚期癌症随机对照临床试验（RCT）疗效的金标准。在生存期通常为数年而不是数月的一线转移性乳腺癌（1 L MBC）中，越来越多地看到OS治疗效果随着时间的流逝而逐渐减弱，后来的线疗法强烈影响OS分析。我们调查了截短的OS（即从随机化到某个时间点后截短的死亡和随访）作为OS的潜在替代终点。方法我们重新分析来自1L MBC中两个RCT的数据，以说明早期治疗效果如何驱动OS结果。自随机化以来，我们根据时间灵活地对危险比（HR）进行建模。我们进行模拟以表征事件数量，样本大小和募集对OS和被截断的OS的对数秩检验的影响的影响，并考虑在存在非比例风险的情况下在12，IB或24个月被截断（非PH）。

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