治疗选择的现实世界证据的价值:结肠癌的案例研究
Lingjie Shen1, Anja van Gestel2, Peter Prinsen2
1Department of Methodology and Statistics, Tilburg University, Tilburg, the Netherlands.
JCO clinical cancer informatics
|May 16, 2024
概括
现实世界的证据 (RWE) 可以指导治疗II和III阶段结肠癌 (CC) 的治疗决策. 这项研究使用RWE来复制荷兰目前的辅助化疗 (ACT) 指南,突出其临床决策潜力.
科学领域:
- 在瘤学瘤学.
- 医疗保健服务研究 医疗服务研究
- 生物统计学 生物统计学
背景情况:
- 现实世界数据 (RWD) 分析产生了针对个性化治疗决策的现实世界证据 (RWE).
- 由于潜在的混因素,生成有效的RWE具有挑战性.
- 本研究涉及负责临床决策的RWE一代.
研究的目的:
- 展示一种负责任地产生RWE的方法,以指导处理决策.
- 通过复制现有的辅助化疗 (ACT) 准则来验证这种RWE生成方法,用于II期和III期结肠癌 (CC).
主要方法:
- 来自荷兰癌症登记处的27,056名II期和III期CC患者的分析.
- 使用G计算,根据患者和瘤特征进行调整,估计ACT的5年整体生存 (OS) 益处.
- 基于估计的患者特异性OS益处构建一个ACT决策树.
主要成果:
- 导出的决策树与现行荷兰指南对ACT在II和III阶段的CC.相一致.
- 该指南建议在III阶段或II阶段 (T4) CC中进行手术和ACT,在II阶段 (T3) CC中仅进行手术.
- 没有发现足够的RWE与II阶段 (T4) CC与微卫星不稳定性高 (MSI-H) 的ACT相矛盾.
结论:
- 当RWE精心生成时,可以补充临床决策的证据,并为治疗指南提供信息.
- 该研究验证了ACT目前对CC的建议,并建议进一步调查MSI-H状态.
- 未来的指导方针代应该考虑MSI-H状态的第二阶段CC处理决策.
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