ImportanceIn oncology randomized clinical trials, suboptimal access to best available care at recurrence (or relapse) may affect overall survival results.ObjectiveTo assess the proportion and the quality of postrecurrence treatment received by patients enrolled in US Food and Drug Administration (FDA) registration trials of systemic therapy in the adjuvant or neoadjuvant setting.Evidence ReviewFor this systematic review, all trials leading to an FDA approval from January 2018 through May 2023 were obtained from the FDA website and drug announcements. Randomized clinical trials of an anticancer drug in the neoadjuvant or the adjuvant setting were included. Trials of supportive care treatment and treatments given in combination with radiotherapy were excluded. Information abstracted for each trial included tumor type, setting, phase, type of sponsor, reporting and assessment of postrecurrence, and overall survival data.FindingsA total of 14 FDA trials met the inclusion criteria. Postrecurrence data were not available in 6 of 14 registration trials (43%). Of the 8 remaining trials, postrecurrence treatment was assessed as suboptimal in 6 (75%). Overall, only 2 of 14 trials (14%) had data assessed as appropriate.Conclusions and RelevanceThis systematic review found that 43% of randomized clinical trials of anticancer treatment in the adjuvant or neoadjuvant context failed to present any assessable postrecurrence treatment data. In instances in which these data were shared, postrecurrence treatment was suboptimal 75% of the time. The findings suggest that regulatory bodies should enforce rules stipulating that patients have access to the best standard of care at recurrence.

中文翻译：

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新辅助或辅助 FDA 注册试验中的复发后治疗


重要性在肿瘤学随机临床试验中，复发时未能获得最佳可用护理可能会影响总体生存结果。目的评估参加美国食品和药物管理局 (FDA) 注册试验的患者接受复发后治疗的比例和质量辅助或新辅助治疗中的全身治疗。证据审查对于本次系统审查，从 2018 年 1 月到 2023 年 5 月获得 FDA 批准的所有试验均来自 FDA 网站和药物公告。包括新辅助或辅助治疗中抗癌药物的随机临床试验。支持性护理治疗和与放疗联合治疗的试验被排除在外。每项试验提取的信息包括肿瘤类型、背景、阶段、申办者类型、复发后报告和评估以及总体生存数据。结果 总共 14 项 FDA 试验符合纳入标准。 14 项注册试验中有 6 项（43%）没有复发后数据。在其余 8 项试验中，有 6 项（75%）的复发后治疗被评估为次优。总体而言，14 项试验中只有 2 项（14%）对数据进行了适当评估。结论和相关性这项系统评价发现，43% 的辅助或新辅助抗癌治疗随机临床试验未能提供任何可评估的复发后治疗数据。在共享这些数据的情况下，75% 的情况下复发后治疗效果不佳。研究结果表明，监管机构应执行规定，规定患者在复发时能够获得最佳标准的护理。