Sintilimab and Cardiovascular Toxicity

Xu discusses the letter by Peng et al which raises concerns about the ORIENT16 trial, which evaluated the combination of sintilimab with chemotherapy in patients with gastric or gastroesophageal junction cancer. They express concern about the lack of reporting on cardiovascular toxicity associated w...

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Bibliographic Details
Published in:JAMA : the journal of the American Medical Association 2024-04, Vol.331 (15), p.1333-1334
Main Authors: Peng, Linfeng, Yang, Dandan, Weng, Cuilian
Format: Article
Language:English
Subjects:
Cardiotoxicity
Chemotherapy
Clinical trials
Immune checkpoint inhibitors
Risk assessment
Toxicity
Troponin
Citations: Items that this one cites
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Summary:Xu discusses the letter by Peng et al which raises concerns about the ORIENT16 trial, which evaluated the combination of sintilimab with chemotherapy in patients with gastric or gastroesophageal junction cancer. They express concern about the lack of reporting on cardiovascular toxicity associated with immune checkpoint inhibitors, which can cause severe adverse events. They highlight the need for better monitoring and reporting of cardiovascular toxicity in clinical trials. They also discuss the exclusion criteria in the ORIENT16 trial and the importance of baseline troponin testing for cardiac risk assessment. They suggest that the omission of troponin testing in the trial is problematic. He concludes by stating that cardiotoxicity was adequately evaluated and reported in the ORIENT16 trial, but they are willing to address any additional concerns.
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.2024.0673