Academic Journal

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

Bibliographic Details
Title: Need for aligning the definition and reporting of cytokine release syndrome (CRS) in immuno-oncology clinical trials.
Authors: Stewart MD; Friends of Cancer Research. Electronic address:, McCall B; Genentech, A Member of the Roche Group., Pasquini M; Medical College of Wisconsin, Center for International Blood and Marrow Transplant Research., Yang AS; Xencor., Britten CD; Amgen., Chuk M; Food and Drug Administration., De Claro RA; Food and Drug Administration., George B; Food and Drug Administration., Gormley N; Food and Drug Administration., Horowitz MM; Medical College of Wisconsin, Center for International Blood and Marrow Transplant Research., Kowack E; Xencor., McCoy C; Bristol Myers Squibb., Morrow PK; Amgen., Okoye E; Regeneron Pharmaceuticals., Ricafort R; Bristol Myers Squibb., Rossi J; CERo Therapeutics., Sharon E; National Cancer Institute., Theoret M; Food and Drug Administration., Vegni F; Bristol Myers Squibb., Yu T; Amgen., Allen J; Friends of Cancer Research.
Source: Cytotherapy [Cytotherapy] 2022 Jul; Vol. 24 (7), pp. 742-749. Date of Electronic Publication: 2022 Feb 23.
Publication Type: Journal Article
Language: English
Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 100895309 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1477-2566 (Electronic) Linking ISSN: 14653249 NLM ISO Abbreviation: Cytotherapy Subsets: MEDLINE
Imprint Name(s): Publication: 2013- : London : Elsevier
Original Publication: Oxford, England : ISIS Medical Media, c1999-
MeSH Terms: Cytokine Release Syndrome*/etiology , Immunotherapy*/adverse effects , Neoplasms*/therapy, Antibodies, Bispecific ; Clinical Trials as Topic ; Humans ; Immunotherapy, Adoptive/adverse effects
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.
(Copyright © 2022. Published by Elsevier Inc.)
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Grant Information: U24 CA233032 United States CA NCI NIH HHS
Contributed Indexing: Keywords: Cytokine Release Syndrome (CRS); Drug development; Immunotherapies; T cell receptors
Substance Nomenclature: 0 (Antibodies, Bispecific)
Entry Date(s): Date Created: 20220227 Date Completed: 20220622 Latest Revision: 20221206
Update Code: 20221216
PubMed Central ID: PMC9721456
DOI: 10.1016/j.jcyt.2022.01.004
PMID: 35219582
Database: MEDLINE