Incidence and risk profile of venous thromboembolic events in patients undergoing immune checkpoint inhibitor therapy
Z S Sandor, D Maraczi, L Jaekyung, M Amha, T Koleszar, P Hollo, V Muller, B Merkely, Z Pozsonyi, Z S DrobniAbstract
Background
Immune checkpoint inhibitors (ICIs) are widely used immunotherapies in oncology. Emerging evidence suggests that ICI therapy may be associated with an elevated risk of venous thromboembolic events (VTEs), however, real-world data remain limited, and no studies have yet evaluated the incidence and risk profile of ICI-associated VTEs in Hungary.
Purpose
The aim of our study was to analyze the incidence and clinical risk factors of VTEs in patients receiving ICI therapy.
Methods
In a retrospective study, we analyzed data from patients who received at least one dose of ICI therapy at our institution in 2023, based on institutional and national public health databases. We systematically recorded the occurrence and timing of VTEs, along with relevant clinical risk factors. The risk of VTE was estimated using the Khorana score. Comparisons between VTE and non-VTE groups were performed using appropriate statistical tests, and multivariate logistic regression was employed to identify independent predictors of VTE (p-values <0.05).
Results
In the overall cohort, 589 patients were analyzed. During a median follow-up period of 748 days, 41 (7%) patients experienced a VTE. Pulmonary embolism was the most frequent type of VTE (n=24, 54.5%), followed by deep vein thrombosis (n=11, 25%). In univariate analysis, the occurrence of VTEs was significantly associated with the presence of tachyarrhythmia (OR 5.03, 95% CI 2.27–11.15, p<0.001), diuretic therapy (OR 2.35, 95% CI 1.24–4.46, p=0.01), corticosteroid therapy (OR 2.47, 95% CI 1.25–4.89, p=0.01), and dementia (OR 5.33, 95% CI 1.36–20.91, p=0.02). These associations did not remain significant in multivariate logistic regression analysis.
Conclusions
VTEs represent a clinically relevant complication among patients receiving ICI therapy, predominantly manifesting as pulmonary embolism. Although several clinical factors were significantly associated with VTE occurrence in univariate analysis, these associations did not remain significant in the multivariate model, underscoring the impact of comorbidity burden and overall clinical complexity. Our results emphasize the importance of systematic risk assessment and vigilant clinical monitoring in this patient population.Venous thromboembolic events (VTEs)