杜尔瓦卢马布和特梅利卢马布组合疗法引起的不良事件:系统性审查和元分析
Hiromi Matsumoto1, Kohei Somekawa1, Nobuyuki Horita2
1Department of Pulmonology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Therapeutic advances in medical oncology
|September 18, 2023
概括
杜尔瓦卢马布加特雷梅利马布 (DT) 组合治疗与不良事件 (AE) 的高发病率有关,大约78%的患者经历任何AE,30%经历严重AE. 这些安全发现对于理解DT至关重要.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床试验 临床试验
背景情况:
- 免疫检查点抑制剂 (ICI) 在癌症治疗中具有显著的治疗益处.
- 杜尔瓦卢马布加上特梅利卢马布 (DT) 是一种新兴的ICI组合疗法,据报道,它在各种癌症中有效.
- DT的综合安全概况,特别是罕见的不良事件 (AE),需要进行彻底的调查.
研究的目的:
- 系统评估与DT组合疗法相关的不良事件 (AE) 的频率.
- 量化特定有害事象的发生率和接受DT的患者的整体安全问题.
- 根据治疗线路 (第一线与后一线) 进行AE频率比较.
主要方法:
- 进行了系统审查和元分析,搜索了四个相关研究的数据库.
- 包括的研究包括随机试验,单臂试验和观察性研究 (前性和后性).
- 关键结果包括任何AE,3级或更高的AE,严重AE,导致停药的AE和与治疗相关的死亡的聚合频率.
主要成果:
- 从30篇文章中对3099名患者的分析显示,任何AE的汇总频率为77.8%,3级AE的频率为29.3%.
- 严重的副作用发生在34.9%的患者中,而13.3%的患者经历了导致治疗中止的副作用.
- 常见的副作用超过15%的发生率包括疲劳 (30.1%),腹 (21.7%), (17.9%),食欲下降 (17.7%) 和恶心 (15.6%).
结论:
- DT组合疗法显示了不良事件的高发病率,大约78%的患者经历了任何AE.
- 很大一部分,大约30%,经历了3级或更高的AEs,不管先前的治疗.
- 这些发现强调了在接受DT治疗的患者中监测和管理AE的重要性.
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