干预性瘤学试验中的生存和代用生物标志物:陷,挑战和未来方向
Ana P Gonzalez1, Adam Swersky1, Riad Salem2
1Department of Radiology, Section of Interventional Radiology, Northwestern Feinberg School of Medicine, 676 N. St. Clair, Suite 800, Chicago, IL, USA.
Cardiovascular and interventional radiology
|January 16, 2026
概括
干预瘤学 (IO) 使用代用终点来评估癌症治疗,但它们在预测患者益处方面的可靠性需要改进. 未来的研究将整合先进的方法,以加强这些关键标记物的验证和接受.
科学领域:
- 干预性瘤学 (IO) 干预性瘤学
- 翻译癌症研究 翻译癌症研究
- 临床试验方法论 临床试验方法论
背景情况:
- 干预瘤学 (IO) 是多学科癌症护理的组成部分,提供最少的侵入性疗法.
- 该领域正在发展,需要强有力的价值证明,特别是通过替代终点.
- 替代终点,如成像和生物标志物,加速治疗评估,但需要严格的验证.
研究的目的:
- 评估代理终点在干预瘤学的作用和挑战.
- 探索代理终点验证的复杂性及其对临床益处的预测.
- 确定在IO研究中加强代用终点实用性的未来方向.
主要方法:
- 审查现有的干预瘤学研究及其使用替代终点.
- 分析影响替代终点采用的监管和方法挑战.
- 检查代理终点在特定癌症 (如肝细胞癌和肝转移) 中的应用.
主要成果:
- 替代终点在IO中加速治疗评估,但它们作为临床益处预测指标的有效性仍在审查中.
- 不一致的验证,定义和报告挑战了替代终点的采用.
- 替代终点的性能和可靠性在研究中异质,特别是在肝癌中.
结论:
- 关于代用终点能够可靠预测持久的临床结果的能力仍然存在不确定性.
- 推进IO需要整合现代试验方法,合成控制臂,放射学和人工智能来进行替代终点验证.
- IO社区必须平衡创新与关键数据解释,以加强其在瘤学中的作用.
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