In a single-institution Belgian study reported in the Journal of Clinical Oncology, Laenens et al found that major adverse cardiovascular events were “more common than currently appreciated” among patients receiving immune checkpoint inhibitors for cancer treatment.
Study Details
The study included 672 patients treated with immune checkpoint inhibitors with or without other systemic treatment at University Hospitals Leuven between June 2010 and January 2020. A matched cohort analysis was performed including 421 patients in the immune checkpoint inhibitor group, 396 patients with cancer who did not receive immune checkpoint inhibitors treatment (non–immune checkpoint inhibitors group), and 399 controls without cancer from the Flemish Study on Environment, Genes and Health Outcomes; cohorts were matched for sex, age, history of cardiovascular disease, and type of cancer (immune checkpoint inhibitor and non–immune checkpoint inhibitor groups). The primary outcome measure was the incidence of major adverse cardiovascular events, defined as acute coronary syndrome, heart failure, stroke, or transient ischemic attack.
Key Findings
During a median follow-up of 13 months (interquartile range [IQR] = 6–22 months), major adverse cardiovascular events occurred in 69 (10.3%) of 672 patients in the total immune checkpoint inhibitors group, most commonly heart failure (n = 48) and acute coronary syndrome (n = 15). Median time to major adverse cardiovascular events was 5 months (IQR = 1–10 months).
In multivariate analysis in the total immune checkpoint inhibitors group, factors significantly associated with increased risk of major adverse cardiovascular events were age, history of heart failure (hazard ratio [HR] = 2.27, 95% confidence interval [CI] = 1.03–5.04, P = .043), and valvular heart disease (HR = 3.01, 95% CI = 1.05–8.66, P = .041).
In the matched cohort analysis, the rates of major adverse cardiovascular events per 100 subject-years were 8.51 in the immune checkpoint inhibitor group, 5.23 in the non–immune checkpoint inhibitor group, and 1.91 in the control group. Hazard ratios vs the immune checkpoint inhibitors group were 0.61 (95% CI = 0.38–0.99, P = .047) for the non–immune checkpoint inhibitors group and 0.24 (95% CI = 0.15–0.37, P ≤ .001) in the control group.
The investigators concluded, “Cardiovascular events during and after immune checkpoint inhibitor treatment are more common than currently appreciated. Patients at risk are those with a history of cardiovascular disease. Compared with matched cancer and population controls, major adverse cardiovascular event incidence rates are significantly higher, suggesting a potential harmful effect of immune checkpoint inhibitor treatment besides the underlying risk.”
Dorien Laenens, MD, of the Department of Cardiology, University Hospitals Leuven, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.
