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免疫检查点抑制剂相关免疫相关不良事件(irAEs)术语的癌症免疫疗法学会(SITC)共识定义。

Society for Immunotherapy of Cancer (SITC) consensus definitions for immune checkpoint inhibitor-associated immune-related adverse events (irAEs) terminology.

发表日期:2023 Mar
作者: Jarushka Naidoo, Catherine Murphy, Michael B Atkins, Julie R Brahmer, Stephane Champiat, David Feltquate, Lee M Krug, Javid Moslehi, M Catherine Pietanza, Joanne Riemer, Caroline Robert, Elad Sharon, Maria E Suarez-Almazor, Karthik Suresh, Michelle Turner, Jeffrey Weber, Laura C Cappelli
来源: Best Pract Res Cl Ob

摘要:

与免疫检查点抑制剂(ICI)治疗有关的免疫相关不良事件(irAEs)在临床表现上可能存在显著差异,包括自然史、治疗结果和模式。由于缺乏共同或一致使用的术语,irAE管理的临床指南应用对医师来说可能具有挑战性。此外,鉴于irAE的临床经验和已发表的数据不断增长,对这些毒性的异质自然史、治疗反应和模式有了更深入的了解,而这目前在irAE指南中还没有得到体现。此外,没有前瞻性试验数据可用于指导不同表现的irAEs的管理。为了认识到irAEs的自然史、治疗反应和模式需要统一术语的需求,免疫治疗学会(SITC)召集了来自学术医学、行业和监管机构的国际知名专家组成的共识小组。专家小组利用修订后的Delphi共识过程,制定了一些irAE术语的临床定义,其中包括与irAE自然史有关的术语(例如,重新发作、慢性活跃、慢性非活跃、延迟/迟发型)、治疗反应(例如,类固醇无效、类固醇依赖性)和模式(例如,多系统irAEs)。SITC制定这些定义以支持采用标准化词汇表,以供irAEs的统一应用临床实践指南,并促进未来irAEs的临床试验。©作者(或其雇主)2023年。在CC BY-NC下允许重复使用。不可进行商业再利用。由BMJ出版。
Immune-related adverse events (irAEs) associated with immune checkpoint inhibitor (ICI) therapy may vary substantially in their clinical presentation, including natural history, outcomes to treatment, and patterns. The application of clinical guidelines for irAE management can be challenging for practitioners due to a lack of common or consistently applied terminology. Furthermore, given the growing body of clinical experience and published data on irAEs, there is a greater appreciation for the heterogeneous natural histories, responses to treatment, and patterns of these toxicities, which is not currently reflected in irAE guidelines. Furthermore, there are no prospective trial data to inform the management of the distinct presentations of irAEs. Recognizing a need for uniform terminology for the natural history, response to treatment, and patterns of irAEs, the Society for Immunotherapy of Cancer (SITC) convened a consensus panel composed of leading international experts from academic medicine, industry, and regulatory agencies. Using a modified Delphi consensus process, the expert panel developed clinical definitions for irAE terminology used in the literature, encompassing terms related to irAE natural history (ie, re-emergent, chronic active, chronic inactive, delayed/late onset), response to treatment (ie, steroid unresponsive, steroid dependent), and patterns (ie, multisystem irAEs). SITC developed these definitions to support the adoption of a standardized vocabulary for irAEs, which will have implications for the uniform application of irAE clinical practice guidelines and to enable future irAE clinical trials.© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.