Sintilimab and Cardiovascular Toxicity

To the Editor A recent randomized clinical trial reported improved overall survival among patients receiving the combination of sintilimab with first-line chemotherapy compared with chemotherapy alone in unresectable gastric or gastroesophageal junction cancer. We are concerned that the ORIENT-16 trial did not report on the cardiovascular toxicity associated with immune checkpoint inhibitors, which can cause severe immune-related adverse events, including cardiovascular toxicity, which although rare can be fatal. However, a systematic review of 48 studies (11  207 patients) reported on 146 patients with cardiovascular toxicity (incidence, 1.3%), 47 of whom (0.42%) had myocarditis. Due to study exclusion criteria and limited cardiac monitoring, we wonder whether cardiovascular toxicity was underestimated in the ORIENT-16 study. The 2021 International Ca rdio-Oncology Society consensus statement has clarified the definition and diagnostic criteria for immune checkpoint inhibitor myocarditis. However, no definition of immune checkpoint inhibitor myocarditis is mentioned in ORIENT-16’s study protocol.
Source: JAMA - Journal of the American Medical Association - Category: General Medicine Source Type: research