与免疫检查点抑制剂相关的心血管毒性:解释临床试验和现实世界数据之间的差异
Amalia Papanikolopoulou1, Helena Michalopoulou2, Konstantinos G Kyriakoulis1
1Third Department of Internal Medicine, Sotiria General Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, GRC.
Cureus
|July 31, 2025
概括
实际数据显示,免疫检查点抑制剂 (ICI) 治疗的癌症患者的心血管免疫相关不良事件 (CV-irAEs) 比临床试验表明的要高. 这些发现强调了ICI治疗中心血管并发症的新兴威胁.
科学领域:
- 心脏病学 心脏病学
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
背景情况:
- 免疫检查点抑制剂 (ICI) 正在彻底改变癌症治疗,但可能导致与免疫相关的不良事件 (irAEs).
- 心血管免疫相关不良事件 (CV-irAEs) 是一个重大问题,现实数据可能与临床试验元分析有所不同.
- 了解不同患者群体中CV-irAEs的发病率和频谱对于风险管理至关重要.
研究的目的:
- 从ICI治疗的癌症患者的观察性研究中估计CV-irAEs的发生率.
- 调查临床试验的元分析与现实世界的观察性研究之间的CV-irAE发病率的差异.
- 确定最常见的CV-IRAE类型及其在ICI治疗期间的时间.
主要方法:
- 按照PRISMA指南进行系统的文献审查和元分析.
- 在PubMed上搜索ICI治疗癌症患者的观察性研究.
- 单臂元分析使用 Stata 汇总特定 CV-irAEs (心肌炎,心律失常等) 的发病率. ) 的情况.
主要成果:
- CV-irAEs的总发病率为8% (95%CI:6%,10%),其中心律不整 (18%),心肌炎 (11%),心力衰竭 (8%) 是最常见的.
- 开始CV-irAE的中位时间为119天.
- 在这次观察性研究的元分析中,发生率高于临床试验元分析中报告的发生率 (0.05%-1.30%).
结论:
- 观察性研究表明,与临床试验数据相比,ICI治疗中CV-irAEs的发生率更高.
- 心律失常,心肌炎和心力衰竭是最常见和最严重的CV-irAEs.
- 这些发现表明CV-irAEs是一个新兴的威胁,可能受到更长的随访期和现实世界的心脏毒性定义的不同影响.
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