癌症尾症临床试验中的瘤和生存终点:尾症终点系列的系统综述6
Olav Dajani1, Iain Philips2, Ester Kristine Størkson1
1Regional Advisory Unit for Palliative Care, Dept. of Oncology, Oslo University Hospital/European Palliative Care Research Centre (PRC), Dept. of Oncology, Oslo University Hospital, and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Journal of cachexia, sarcopenia and muscle
|March 11, 2025
概括
癌症缓解症 (CC) 试验经常报告二次瘤终点,但很少有重大发现. 未来的CC研究需要同质的患者队列和强大的统计方法来获得可靠的结果.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 营养科学 营养科学
背景情况:
- 癌症缓解症 (CC) 对瘤学结果产生负面影响.
- 对于CC试验的瘤终点的理解有限,也没有系统审查.
- 本综述系统地检查了CC临床试验中的瘤终点.
研究的目的:
- 系统地审查和分析癌症终点,用于癌症缓解症 (CC) 临床试验.
- 确定CC研究中瘤结果报告的趋势和局限性.
- 为未来的CC试验设计和终端选择提供建议.
主要方法:
- 在MEDLINE,Embase和Cochrane数据库 (1990-2023) 中进行系统的文献搜索.
- 纳入标准:参与者≥18岁,受控设计,≥40名参与者,缓冲症干预>14天,并报告瘤终点.
- 数据提取遵循PRISMA指导方针;在PROSPERO.注册的审查.
主要成果:
- 57项试验 (9743名患者) 符合条件,重点关注肺癌,胰腺癌,头癌和肠胃癌.
- 通常报告的瘤终点包括整体存活率 (OS,46项试验) 和不良事件 (AE,42项试验).
- 报告了OS,无进展生存期 (PFS) 或响应率 (RR) 的少数重要发现;可靠性受到统计问题和对功率计算的不良遵守限制.
结论:
- 在CC试验中的瘤终点主要是次要的,产生有限的显著结果.
- 患者群体,干预措施和结果报告的异质性阻碍了关于CC治疗的坚定结论.
- 未来的CC试验需要均的队列,适当的功率分析,以及对OS和AE的标准化统计报告,以产生有意义的结果.
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