副作用登记册免疫瘤学 (SERIO) - 一种用于系统分析免疫治疗诱导的副作用的工具
Carolin Ertl1, Theresa Ruf1, Dirk Mentzer2
1Department of Dermatology and Allergy, LMU University Hospital, LMU Munich, Munich, Germany; SERIO Registry (www.serio-registry.org).
概括
副作用登记免疫瘤学 (SERIO) 数据库捕获免疫治疗的罕见免疫相关不良事件 (irAEs). 这些真实数据有助于管理严重的副作用,并改善免疫瘤学患者的治疗结果.
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:
- 免疫疗法,包括免疫检查点抑制剂 (ICI),在各种癌症中提供显著的临床益处,但与各种副作用有关.
- 现实世界的数据分析对于识别新的安全信号,理解诊断特征,评估风险和评估免疫疗法诱导的副作用的治疗结果至关重要.
研究的目的:
- 为罕见,复杂和严重的免疫疗法诱导的副作用建立一个全面的现实世界的证据基础.
- 促进改善副作用管理,风险评估和了解免疫瘤学中的病理机制.
主要方法:
- 国际副作用登记免疫瘤学 (SERIO) 数据库收集有关患者和瘤特征,免疫治疗类型,副作用管理和结果的结构化数据.
- 该注册表使用一个关系数据库管理系统,有25个器官模块,包括针对免疫效应细胞相关的神经毒性综合征 (ICANS) 和细胞因子释放综合征 (CRS) 的特定模块.
- 数据捕获包括对生物样本进行进一步调查的信息.
主要成果:
- 在13个国家58个中心的17种瘤类型中,SERIO记录了1398个与免疫相关的不良事件 (irAEs).
- 神经 (7.6%),肺 (4.0%) 和心脏毒性 (2.9%) 是通过九种不同的免疫疗法诱导的观察到的irrAEs之一.
- 50%的irrAEs是严重的或危及生命的,其中23.0%的患者需要因耐火性或依赖性irrAEs进行二线治疗.
结论:
- 强有力的证据基础对于管理罕见,复杂或耐受性免疫相关不良事件至关重要.
- 该SERIO注册表提供了一个宝贵的资源,以优化副作用管理,从而减少免疫治疗相关的发病率和死亡率.
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