Evidence map›Paper›PMID 34711339›Full record

ArticleJournal of the American College of Cardiology2021

Adverse Cardiovascular and Pulmonary Events Associated With Chimeric Antigen Receptor T-Cell Therapy.

Adam Goldman, Elad Maor, David Bomze, Jennifer E Liu, Joerg Herrmann, Joshua Fein, Richard M Steingart, Syed S Mahmood, Wendy L Schaffer, Miguel-Angel Perales and 1 more

Open access · greenAbstract read
In one paragraph

Article in Journal of the American College of Cardiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 102 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 5 pooled it
9.2field-weighted citation impact, top 1% 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

102 citing papers in PubMed, 5 syntheses or guidelines pooled it, 141 citations in OpenAlex.

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  6. Review
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  10. Cardiotoxicity of T cell immunotherapies.Nature reviews. Cardiology · 2026
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42 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 2 countries.

Adam GoldmanLeviev Heart Center, Chaim Sheba Medical Center, Ramat Gan, Israel; School of Medicine, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Elad MaorLeviev Heart Center, Chaim Sheba Medical Center, Ramat Gan, Israel; School of Medicine, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
David BomzeSchool of Medicine, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Jennifer E LiuCardiology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA; Department of Medicine, Weill Cornell Medical College, New York, New York, USA.
Joerg HerrmannDepartment of Cardiovascular Disease, Mayo Clinic, Rochester, Minnesota, USA.
Joshua FeinDepartment of Internal Medicine, UCONN Health, Farmington, Connecticut, USA.
Richard M SteingartCardiology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA; Department of Medicine, Weill Cornell Medical College, New York, New York, USA.
Syed S MahmoodCardiology Division, New York-Presbyterian Hospital, Weill Cornell Medical Center, New York, New York, USA.
Wendy L SchafferCardiology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA; Department of Medicine, Weill Cornell Medical College, New York, New York, USA.
Miguel-Angel PeralesDepartment of Medicine, Weill Cornell Medical College, New York, New York, USA; Adult Bone Marrow Transplantation Service, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Roni ShouvalDepartment of Medicine, Weill Cornell Medical College, New York, New York, USA; Adult Bone Marrow Transplantation Service, Memorial Sloan Kettering Cancer Center, New York, New York, USA. Electronic address: shouvalr@mskcc.org.
Mayo Clinic · USTel Aviv University · ILUConn Health · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
TrAstuzumab Cardiomyopathy Therapeutic Intervention with Carvedilol (TACTIC) TrialR01CA233610 · NCI · MAYO CLINIC ROCHESTER · PI HERRMANN, JOERG, RUDDY, KATHRYN JEAN · 2019 to 2024
$4.3M
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA233610
6 · The paper itself

Abstract

backgroundPivotal trials of chimeric antigen receptor T-cell (CAR-T) have identified common toxicities but may have been underpowered to detect cardiovascular and pulmonary adverse events (CPAEs).

objectivesThis study sought to investigate CPAEs associated with commercial CD19-directed CAR-T therapy.

methodsIn this retrospective, pharmacovigilance study, the authors used the Food and Drug Administration adverse event reporting system to identify CPAEs associated with axicabtagene-ciloleucel and tisagenlecleucel. The authors evaluated disproportionate reporting by the reporting odds ratio (ROR) and the lower bound of the information component 95% credibility interval (IC

resultsThe authors identified CAR-T reports of 2,657 patients, including 546 CPAEs (20.5%). CPAEs overlapped with cytokine release syndrome in 68.3% (373 of 546) of the reports. Compared with the full database, CAR-T was associated with overreporting of tachyarrhythmias (n = 74 [2.8%], adj.ROR = 2.78 [95% CI: 2.21-3.51]), cardiomyopathy (n = 69 [2.6%], adj.ROR = 3.51 [2.42-5.09]), pleural disorders (n = 46 [1.7%], adj.ROR = 3.91 [2.92-5.23]), and pericardial diseases (n = 11 [0.4%], adj.ROR = 2.26 [1.25-4.09], all IC

conclusionsIn this largest post-marketing study to date, the authors identified an association between CAR-T and various CPAEs, including tachyarrhythmias, cardiomyopathy, pericardial and pleural disorders, and VTEs. These findings should be considered in the multidisciplinary assessment for and monitoring of CAR-T therapy recipients.

Indexed as

Biological ProductsCardiotoxicityCardiovascular DiseasesImmunotherapy, AdoptiveLung DiseasesAdverse Drug Reaction Reporting SystemsAntineoplastic Agents, ImmunologicalDrug MonitoringHumansNeeds AssessmentPharmacovigilanceReceptors, Antigen, T-CellUnited StatesUnited States Food and Drug AdministrationAntineoplastic Agents, Immunologicalaxicabtagene ciloleucelBiological ProductsCD19-specific chimeric antigen receptorReceptors, Antigen, T-Celltisagenlecleucelcardiac arrhythmiascardio-oncologycardiovascular adverse eventschimeric antigen receptor T cellpharmacovigilancevenous thromboembolism

Identifiers

PMID34711339
PMCPMC8562317
OpenAlexW3210942732

What OpenQuestion holds

Textmetadata
LicenceTDM
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.