Abstract 1698: Cardiovascular adverse events associated with immune checkpoint blockade: analysis of FDA-adverse events database

Abstract Background: Modern therapies in oncology have increased cancer survivorship, as well as the incidence of de novo cardiovascular events. While immune checkpoint inhibitors have shown significant clinical impact in several cancer types, the frequency of immune related adverse events is common. Methods: We performed big data analytics on the FDA Adverse Events Reporting data of immunotherapy compared to chemotherapy adverse cases from January 2010- March 2020. We identified 90, 740 adverse event reports in both treatment groups. Myocarditis was significantly associated with patients receiving anti-PD-(L)1, 23.86 (95% CI 11.76-48.42, P < 0.001) and combination immunotherapy, 7.29 (95% CI 1.03- 51.89, P < 0.001). Myocarditis was most common in non-small cell lung cancer, melanoma, and renal cell carcinoma. Heart failure was significantly associated in chemotherapy compared to PD-(L)1, 0.50 (95% CI 0.37- 0.68, P < 0.001), CTLA4, 0.08 (95% CI 0.03-0.20, P<0.001), and combination immunotherapy, 0.25 (95%CI 0.13-0.48). Additionally, we observe a sexual dimorphism towards males in cardiac adverse reports for arrhythmia, 0.81 (95%CI 0.75-0.87, P <0.001), coronary artery disease, 0.63 (95%CI 0.53- 0.76, P <0.001), myocardial infarction, 0.6 (95%CI 0.53 -0.67, P<0.001), myocarditis, 0.59 (95%CI 0.47- 0.75, P < 0.001) and pericarditis, 0.5 (95% CI 0.35- 0.73, P <0.001). Conclusion: Our study provides the current risk estimates of cardiac adverse events in patients treated with immunotherapy. Understanding the clinical risk factors that predispose immunotherapy treated cancer patients to fulminant myocarditis is crucial in Cardio-Oncology management. Citation Format: Jessica A. Castrillon. Cardiovascular adverse events associated with immune checkpoint blockade: analysis of FDA-adverse events database [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 1698.