Real-World Cardiovascular Adverse Events Associated With ICIs in the United States

Study findings highlight the importance of risk stratification and cardiovascular monitoring for patients with cancer receiving immune checkpoint inhibitor (ICI) therapy (ESMO Open. 2021; 6[6]:100286. doi:10.1016/j.esmoop.2021.100286). 

There is a poor understanding of the life-threatened cardiovascular adverse events (CVAEs) associated with ICIs. 

“The outcomes of clinical trials may underestimate treatment-related adverse events due to restrictive eligibility, limited sample size, and failure to anticipate selected toxicities,” wrote Prantesh Jain, MD, FACP, Department of Hematology and Medical Oncology, University Hospitals-Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, and colleagues.

Authors aimed to analyze the incidence and clinical determinants of CVAEs in a real-world population on ICI therapy.

About 0.61% of patients diagnosed with cancer between 2011 and 2018 received ICIs for treatment.  In this study, those who received ICI and those who did not were matched in a 1:1 ratio according to age, sex, National Cancer Institute comorbidity score, and primary cancer. The patients who did not receive ICIs were divided into two groups based upon whether they received chemotherapy (n = 2875) or targeted agents (n = 4611).  

Authors analyzed non-cardiac immune-related adverse events occurring after treatment initiation, CVAEs, baseline comorbidities, and treatment details using diagnosis and billing codes.

The median age for participants was 61 years in the ICI group, and 65 years in the non-ICI group. The most common cancer types were lung cancer at 43.1%, melanoma at 30.4%, and renal cell carcinoma at 9.9%. The incidence proportion in the ICI cohort of CVA diagnoses were 4.6% for stroke, 3.5% for heart failure, 2.1% for atrial fibrillation, 1.5% for conduction disorders, 0.9% for myocardial infarction, 0.05% for myocarditis, 0.05% for vasculitis, and 0.2% for pericarditis. 

Risk of heart failure and stroke increased with anti-cytotoxic T-lymphocyte-associated protein 4. In patients receiving ICIs, Pneumonitis was associated with heart failure and encephalitis with conduction disorders. Advanced age, primary cancer, nephritis, and anti-cytotoxic T-lymphocyte-associated protein 4 therapy were commonly associated with CVAEs.

“Our findings underscore the importance of risk stratification and cardiovascular monitoring for patients on ICI therapy,” Dr Jain and colleagues concluded.