Evidence map›Paper›PMID 35219582›Full record

ArticleCytotherapy2022

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

Mark D Stewart, Bruce McCall, Marcelo Pasquini, Allen S Yang, Carolyn D Britten, Meredith Chuk, R Angelo De Claro, Bindu George, Nicole Gormley, Mary M Horowitz and 11 more

Open access · hybridAbstract read
In one paragraph

Article in Cytotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Clinical Pharmacology of Cytokine Release Syndrome with T-Cell-Engaging Bispecific Antibodies: Current Insights and Drug Development Strategies.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Review
  6. Article
  7. rWTC-MBTA: autologous vaccine prevents metastases via antitumor immune responses.Journal of experimental & clinical cancer research : CR · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 8 institutions in 4 countries.

Mark D StewartFriends of Cancer Research. Electronic address: mstewart@focr.org.
Bruce McCallGenentech, A Member of the Roche Group.
Marcelo PasquiniMedical College of Wisconsin, Center for International Blood and Marrow Transplant Research.
Allen S YangXencor.
Carolyn D BrittenAmgen.
Meredith ChukFood and Drug Administration.
R Angelo De ClaroFood and Drug Administration.
Bindu GeorgeFood and Drug Administration.
Nicole GormleyFood and Drug Administration.
Mary M HorowitzMedical College of Wisconsin, Center for International Blood and Marrow Transplant Research.
Eric KowackXencor.
Candice McCoyBristol Myers Squibb.
Phuong Khanh MorrowAmgen.
Emmanuel OkoyeRegeneron Pharmaceuticals.
Rosanna RicafortBristol Myers Squibb.
John RossiCERo Therapeutics.
Elad SharonNational Cancer Institute.
Marc TheoretFood and Drug Administration.
Ferdinando VegniBristol Myers Squibb.
Tai YuAmgen.
Jeff AllenFriends of Cancer Research.
Food and Drug Administration · THAmgen (United States) · USBristol-Myers Squibb (Germany) · DEFriends of Cancer Research · USMedical College of Wisconsin · USXencor (United States) · USRegeneron (United States) · USRoche (Switzerland) · CH

Funding

Data Resource for Analyzing Blood &Marrow TransplantsU24CA076518 · NCI · MEDICAL COLLEGE OF WISCONSIN · PI Amy M Moskop, Bronwen Shaw · 1998 to 2026
$105.2M
Immuno-Oncology Translation Network (IOTN): Cellular Immunotherapy Data Resource (CIDR)U24CA233032 · NCI · MEDICAL COLLEGE OF WISCONSIN · PI PASQUINI, MARCELO C. · 2018 to 2019
$9.0M
NCI NIH HHS U24 CA076518NCI NIH HHS U24 CA233032
6 · The paper itself

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.

Indexed as

Cytokine Release SyndromeImmunotherapyNeoplasmsAntibodies, BispecificClinical Trials as TopicHumansImmunotherapy, AdoptiveAntibodies, BispecificCytokine Release Syndrome (CRS)Drug developmentImmunotherapiesT cell receptors

Identifiers

PMID35219582
PMCPMC9721456
OpenAlexW4213293672

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.