Design considerations for randomized comparisons of neoadjuvant-adjuvant versus adjuvant-only cancer immunotherapy when tumor measurement schedules do not align (SWOG S1801).

IF 2.2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Megan Othus, Elad Sharon, Michael C Wu, Vernon K Sondak, Antoni Ribas, Sapna P Patel
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引用次数: 0

Abstract

BackgroundIn 2022, SWOG S1801 was the first trial to demonstrate that single-agent anti-PD-1 checkpoint inhibition used as neoadjuvant-adjuvant therapy leads to significantly improved outcomes compared to adjuvant-only therapy. Endpoints in trials comparing neoadjuvant-adjuvant to adjuvant strategies need special consideration to ensure that event measurement timing is appropriately accounted for in analyses to avoid biased comparisons artificially favoring one arm over another.MethodsThe S1801 trial is used a case study to evaluate the issues involved in selecting endpoints for trials comparing neoadjuvant-adjuvant versus adjuvant-only strategies.ResultsDefinitions and timing of measurement of events is provided. Trial scenarios when recurrence-free versus event-free survival should be used are provided.ConclusionsIn randomized trials comparing neoadjuvant-adjuvant to adjuvant-only strategies, event-free survival endpoints measured from randomization are required for unbiased comparison of the arms. The time at which events can be measured on each arm needs to be carefully considered. If measurement of events occurs at different times on the randomized arms, modified definitions of event-free survival must be used to avoid bias.

当肿瘤测量计划不一致时,新辅助与仅辅助的癌症免疫治疗随机比较的设计考虑(SWOG S1801)。
在2022年,SWOG S1801是首个证明单药抗pd -1检查点抑制作为新辅助辅助治疗与单纯辅助治疗相比可显著改善疗效的试验。在比较新佐剂-佐剂和辅助策略的试验中,终点需要特别考虑,以确保在分析中适当考虑事件测量时间,以避免人为偏向某一组的偏倚比较。方法S1801试验是一个案例研究,用于评估新佐剂-佐剂与单纯佐剂策略比较试验中选择终点所涉及的问题。结果给出了事件测量的定义和时间。提供了使用无复发生存期和无事件生存期的试验方案。结论:在比较新佐剂与单纯佐剂策略的随机试验中,从随机化中测量的无事件生存终点需要用于两组的无偏比较。在每条手臂上测量事件发生的时间需要仔细考虑。如果随机组的事件测量发生在不同时间,则必须使用修改后的无事件生存期定义以避免偏倚。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Clinical Trials
Clinical Trials 医学-医学:研究与实验
CiteScore
4.10
自引率
3.70%
发文量
82
审稿时长
6-12 weeks
期刊介绍: Clinical Trials is dedicated to advancing knowledge on the design and conduct of clinical trials related research methodologies. Covering the design, conduct, analysis, synthesis and evaluation of key methodologies, the journal remains on the cusp of the latest topics, including ethics, regulation and policy impact.
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