Friends of Cancer Research.
Genentech, A Member of the Roche Group.
Cytotherapy. 2022 Jul;24(7):742-749. doi: 10.1016/j.jcyt.2022.01.004. Epub 2022 Feb 23.
As cancer immunotherapies continue to expand across all areas of oncology, it is imperative to establish a standardized approach for defining and capturing clinically important toxicities, such as cytokine release syndrome (CRS). In this paper, we provide considerations for categorizing the variety of adverse events that may accompany CRS and for recognizing that presentations of CRS may differ among various immunotherapies (e.g., monoclonal antibodies, CAR T cell therapies and T cell engagers, which can include bispecific antibodies and other constructs). The goals of this paper are to ensure accurate and consistent identification of CRS in patients receiving immunotherapies in clinical studies to aid in reporting; enable more precise evaluation of the therapeutic risk-benefit profile and cross-study analyses; support evidence-based monitoring and management of important toxicities related to cancer immunotherapies; and improve patient care and outcomes. These efforts will become more important as the number and variety of molecular targets for immunotherapies broaden and as therapies with novel mechanisms continue to be developed.
随着癌症免疫疗法在肿瘤学的各个领域不断扩展,为定义和捕捉具有临床重要意义的毒性(如细胞因子释放综合征[CRS])建立标准化方法至关重要。本文提供了对可能伴随 CRS 的各种不良事件进行分类的注意事项,并认识到不同免疫疗法(例如单克隆抗体、嵌合抗原受体 T 细胞疗法和 T 细胞衔接器,其中可能包括双特异性抗体和其他构建体)的 CRS 表现可能不同。本文的目的是确保在临床研究中准确一致地识别接受免疫疗法的患者的 CRS,以辅助报告;能够更精确地评估治疗的风险-获益特征和跨研究分析;支持基于证据的监测和管理与癌症免疫疗法相关的重要毒性;并改善患者的护理和结果。随着免疫疗法的分子靶点数量和种类的增加,以及具有新型机制的疗法不断开发,这些努力将变得更加重要。
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