在三项I期试验中,结合了除性放射治疗和免疫检查点抑制剂的安全性
Connor Lynch1, Mark C Korpics1, Rohan R Katipally1
1The University of Chicago Medical Center, Department of Radiation and Cellular Oncology, United States.
概括
与免疫检查点抑制剂 (ICI) 结合立体辐射疗法 (SBRT) 是安全的治疗转移性疾病. 谨慎的SBRT输送优先考虑正常组织的限制,确保SBRT和ICI一起使用时的安全性.
科学领域:
- 在瘤学瘤学.
- 辐射瘤学 辐射瘤学
- 免疫治疗是一种免疫疗法.
背景情况:
- 立体性身体放射疗法 (SBRT) 是对脑外转移性疾病的经过验证的治疗方法.
- 结合SBRT与免疫检查点抑制剂 (ICI) 的安全性需要全面报告.
研究的目的:
- 报告与SBRT和ICI组合相关的不良事件 (AE).
- 分析接受SBRT和ICI联合治疗的患者的生存结果.
主要方法:
- 分析了三项涉及多地点SBRT和ICI (pembrolizumab;基于nivolumab的疗法) 的试验的前性数据.
- 使用CTCAE v4.0记录了不良事件,并通过Kaplan-Meier和Fine-Gray回归分析了AE协会的生存率.
主要成果:
- 在213名患者中,50%的患者经历了等级≥2的副作用;27%的患者在10个月的随访时间内经历了等级≥3的副作用.
- 双剂ICI与3级以上的副作用有显著的关联.
- 在患有或没有等级≥3AEs的患者之间,没有观察到无进展或总生存时间的显著差异.
结论:
- 多站点SBRT和ICI可以安全地联合管理.
- 在SBRT交付期间优先考虑正常组织约束对于安全至关重要.
- 这些发现为未来的试验设计提供了背景,研究SBRT和ICI组合.
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