在泛免疫疗法数据商店中确定保存的与免疫相关的不良事件风险因素和临床结果
David F Lamparter1, Virginia C Schmid1, Rajat Mohindra2
1Roche Pharma Research and Early Development, F Hoffmann-La Roche, Basel, BS, Switzerland.
Journal for immunotherapy of cancer
|November 14, 2025
概括
与免疫相关的不良事件 (irAEs) 在癌症免疫疗法 (CITs) 之间有所不同. 皮肤毒性与更好的结果相关,而肝炎表明预后较差,这表明irAEs可以预测治疗成功.
科学领域:
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 癌症免疫疗法 (CIT) 可以引起与免疫相关的不良事件 (irAEs).
- 虽然检查点抑制剂 (CPI) 试验中的irAEs得到了充分的研究,但关于非标准CIT的数据有限.
- 在新型CIT中预测irAEs的生物标志物对于患者护理至关重要.
研究的目的:
- 在早期CIT试验中分析irAEs.
- 确定与irAE发生率,严重程度和发病相关的因素.
- 探索irAEs对临床结果的预测价值.
主要方法:
- 分析了27项早期CIT试验 (3608名患者) 的协调数据.
- 包括临床数据,瘤特征,可溶性生物标志物和全基因组基因型定型.
- 分析评估了irAE发作的风险因素;探索了irAE对无进展生存 (PFS) 的预测价值.
主要成果:
- 在CIT分子中观察到的irAE发生率和动力学的显著变化.
- 常见的IRE包括肝炎 (通常严重) 和皮疹 (轻微);肝炎与免疫细胞因子相关,T细胞双特异性对器官有毒性.
- 疹与改善的PFS相关,而肝炎表明预后较差,独立于基线预后得分.
结论:
- CIT类,瘤负担,转移部位和全身免疫状态都会影响irAE的发展.
- 皮肤毒性可能作为系统性免疫激活的标志物,并预测改善PFS.
- 了解irAEs对于管理新型癌症免疫疗法和预测患者结果至关重要.
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