癌症老年人随机对照试验的主要终点:范围审查
Tomonori Mizutani1, Funato Sato2, Kohei Uemura3
1Department of Thoracic Oncology, National Cancer Center, Tokyo, Japan.
Journal of geriatric oncology
|January 30, 2026
概括
对老年人进行的癌症试验主要使用生存终点,忽视了以患者为中心的结果,如生活质量. 需要更多的研究来纳入这些新的终点,以便更好地设计和应用试验.
科学领域:
- 老年瘤学 老年瘤学
- 临床试验设计 临床试验设计
- 基于证据的医学基于证据的医学.
背景情况:
- 老年人是一个不断增长的癌症患者群体.
- 传统的癌症试验优先考虑基于瘤的终点 (例如,整体存活率),可能忽视患者重要的结果,如生活质量和功能状态.
- 本综述检查了癌症老年人的随机对照试验 (RCT) 中的主要终点.
研究的目的:
- 系统地表征65岁及以上癌症成年人确认RCT中的初级终点.
- 评估反映患者优先事项的新型终点的定义和分析.
主要方法:
- 搜索了PubMed,CINAHL和Cochrane图书馆的英语确认性RCT,专门招募65岁以上的癌症成年人.
- 分类的终点为传统的 (基于瘤) 或新的 (非基于瘤).
- 提取了关于终点定义,测量工具和统计方法的数据.
主要成果:
- 在66个符合条件的RCT中,确定了71个主要终点; 74.6%是传统的 (主要是总生存率,无进展生存率,无疾病生存率).
- 新的终点 (25.3%) 包括与健康相关的生活质量,毒性,老年评估和患者满意度.
- 新的终点,特别是毒性和功能衰退的定义和统计应用是不一致的.
结论:
- 对于老年人来说,生存仍然是癌症RCT的主要终点,与患者相关的结果不一致整合.
- 需要在临床试验设计中更好地纳入以患者为中心的结果.
- 解决这些差距可以提高研究成果对癌症老龄化人口的实际应用性.
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