与免疫相关的不良事件发生在单剂量免疫检查点阻塞剂后迅速发生
Romain Guitton1, Ariane Laparra2, Noemie Chanson3
1Internal Medicine and Clinical Immunology, Nancy University Hospital Center, Nancy, France.
Journal for immunotherapy of cancer
|September 24, 2025
概括
一次剂量抗编程死亡配体1 (PD-L) 1治疗可以导致严重的免疫相关不良事件 (irAEs),包括致命的结果,在癌症患者. 由于缺乏预测标志物,在初始治疗期间加强监测至关重要.
科学领域:
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
- 药物监督 药物监督 药物监督
背景情况:
- 免疫检查点阻塞 (ICB) 剂量在癌症治疗中至关重要.
- 与免疫相关的不良事件 (irAEs) 在ICB中很常见.
- 单次抗PD-(L) 1剂后发生irrAEs的风险尚未研究.
研究的目的:
- 调查第一剂抗PD-(L) 1治疗后的irAEs的发生率和特征.
- 评估在初始暴露于抗PD-L1后的irAEs的严重程度,包括致命事件.
- 为了确定严重或早期发作的IRE的潜在预测标志物.
主要方法:
- 在Gustave Roussy的单中心前性队列研究.
- 使用了来自法国REISAMIC注册表 (药监数据库) 的数据.
- 包括患有晚期/转移性癌症的成年患者,接受他们的第一个抗PD-(L) 1输液,监测到第二剂量.
主要成果:
- 1.96% (70/3565) 的患者经过单次抗PD-(L) 1输液后经历了irrAEs.
- 在37.1% (20/70) 的受影响患者中,发生了严重的 (3-4级) 染性反应,在4.3% (3/70) 的受影响患者中发生了致命的 (5级) 染性反应.
- 最常见的irrAEs涉及皮肤,肌肉骨,内分泌和心血管系统,平均发病时间为14天;没有确定任何预测标志物.
结论:
- 单剂量抗PD-(L) 1疗法在晚期癌症患者中具有严重和致命的irrAEs的显著风险.
- 由于缺乏预测标志物,因此在治疗的早期阶段需要加强患者监测.
- 需要进一步的研究来优化ICB剂量方案,以提高安全性和有效性.
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