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有必要统一免疫肿瘤学临床试验中细胞因子释放综合征(CRS)的定义和报告标准。

Need for aligning the definition and reporting of cytokine release syndrome (CRS) in immuno-oncology clinical trials.

机构信息

Friends of Cancer Research.

Genentech, A Member of the Roche Group.

出版信息

Cytotherapy. 2022 Jul;24(7):742-749. doi: 10.1016/j.jcyt.2022.01.004. Epub 2022 Feb 23.


DOI:10.1016/j.jcyt.2022.01.004
PMID:35219582
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9721456/
Abstract

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.

摘要

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/488b/9721456/e9d88ebbae77/nihms-1799683-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/488b/9721456/05e9d9cdb6fb/nihms-1799683-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/488b/9721456/e9d88ebbae77/nihms-1799683-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/488b/9721456/05e9d9cdb6fb/nihms-1799683-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/488b/9721456/e9d88ebbae77/nihms-1799683-f0002.jpg

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Need for aligning the definition and reporting of cytokine release syndrome (CRS) in immuno-oncology clinical trials.

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引用本文的文献

[1]
Clinical Pharmacology of Cytokine Release Syndrome with T-Cell-Engaging Bispecific Antibodies: Current Insights and Drug Development Strategies.

Clin Cancer Res. 2025-1-17

[2]
Identification of cytokine release syndrome and indicators of severity in retrospective databases among patients receiving immunotherapy.

Pharmacol Res Perspect. 2024-12

[3]
Prophylactic use of interleukin 6 monoclonal antibody can reduce CRS response of CAR-T cell therapy.

Front Med (Lausanne). 2024-1-3

[4]
rWTC-MBTA: autologous vaccine prevents metastases via antitumor immune responses.

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本文引用的文献

[1]
Management of Immune-Related Adverse Events in Patients Treated With Chimeric Antigen Receptor T-Cell Therapy: ASCO Guideline.

J Clin Oncol. 2021-12-10

[2]
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events.

J Immunother Cancer. 2020-12

[3]
The model of cytokine release syndrome in CAR T-cell treatment for B-cell non-Hodgkin lymphoma.

Signal Transduct Target Ther. 2020-7-29

[4]
Immuno-oncology drug development goes global.

Nat Rev Drug Discov. 2019-11

[5]
Cytokine Release Syndrome: Current Perspectives.

Immunotargets Ther. 2019-10-29

[6]
Management of cytokine release syndrome: an update on emerging antigen-specific T cell engaging immunotherapies.

Immunotherapy. 2019-7

[7]
ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.

Biol Blood Marrow Transplant. 2018-12-25

[8]
Cytokine release syndrome.

J Immunother Cancer. 2018-6-15

[9]
CAR T cell-induced cytokine release syndrome is mediated by macrophages and abated by IL-1 blockade.

Nat Med. 2018-5-28

[10]
FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell-Induced Severe or Life-Threatening Cytokine Release Syndrome.

Oncologist. 2018-4-5

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