免疫检查点抑制剂的不良药物事件 - 一个回顾性,描述性的现实世界数据分析
Lauris Annatha Mariam Auch1,2, Chloé Sieber3,4, Dirk Lehnick3,4
1Faculty of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland. lauris.auch@gmail.com.
BMC cancer
|August 12, 2025
概括
近一半的患者在免疫治疗中经历了与免疫相关的不良事件 (irAEs),女性报告的irAEs比男性更多. 需要有结构的文档,以便在现实数据中更好地跟踪irAE.
科学领域:
- 免疫学和瘤学
- 临床药理学 临床药理学
- 现实世界的证据研究研究.
背景情况:
- 免疫相关不良事件 (irAEs) 是免疫检查点抑制剂 (ICI) 治疗的常见并发症.
- 了解irAE发生率和特征对于患者管理和治疗优化至关重要.
研究的目的:
- 分析与ICI治疗的真实世界患者队列中的irAEs的发病率和特征.
- 根据器官系统,严重程度,治疗剂和性别来调查irAE发生的变化.
主要方法:
- 在2020年1月至2023年5月期间,对500名接受抗CTLA-4,抗PD-1或抗PD-L1抑制剂治疗的患者进行了回顾性分析.
- 在电子健康记录中记录的IRAE使用CTCAE标准进行分级并进行描述性分析.
主要成果:
- 总体而言,43.2%的患者至少经历过一次irAE,女性 (47.4%) 的发病率高于男性 (40.5%).
- 在13.6%的患者中,发生严重的 (等级≥3) 染性反应. 最常见的irrAEs包括皮肤 (15.2%),胃肠道 (13.0%) 和内分泌 (10.8%).
结论:
- 免疫检查点抑制剂与显著的IRAE负担有关,特别是在女性中.
- 当前的文档实践可能会低估IRE,突出显示需要采用结构化数据收集进行前性研究.
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