Key result
Lenvatinib exhibited the strongest signal for thromboembolic events among VEGFR-TKIs, with a reporting odds ratio of 3.29 compared to the background database frequency.
Why the study?
The anti-angiogenic effect of VEGFR-TKIs significantly increases the incidence of cardiovascular adverse events, motivating a comprehensive analysis of VEGFR-TKI-related thromboembolic events.
Are VEGFR-TKIs associated with an increased risk of thromboembolic events in real-world patients?
Observational (n=90,206)
Are VEGFR-TKIs associated with an increased risk of thromboembolic events in real-world patients?
VEGFR-TKIs, particularly lenvatinib, are associated with a significant risk of arterial and venous thromboembolic events in real-world settings, highlighting the need for cardiovascular monitoring during therapy.
Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) represent a class of targeted drugs that have changed the cancer therapy landscape. However, the anti-angiogenic effect of VEGFR-TKIs significantly increase the incidence of cardiovascular adverse events (AEs). In this study, we conducted a comprehensive analysis of VEGFR-TKI-related thromboembolic events (TEEs), using data from the FAERS database between the drug launch and the third quarter of 2023. Disproportionality analysis, including reporting odds ratio, proportional reporting ratio, bayesian confidence propagation neural network, and multi-item gamma poisson shrinker, were used to explore the correlation between VEGFR-TKIs and TEEs. The total number of reported TEEs was 2688, representing 2.98% of all AEs associated with VEGFR-TKIs. A total of 17 and 12 preferred terms of arterial and venous thromboembolic events were observed in 8 VEGFR-TKIs. Lenvatinib, a VEGFR-TKI with low selectivity and high potency, exhibited the strongest TEE signal. A tendency of an increased signal of disproportionate reporting of TEEs was observed in sorafenib, regorafenib, and sunitinib. Indication, gender, age, drug class, concomitant medication and AEs may influence the occurrence of VEGFR-TKI-related TEEs. This study illustrates that TEEs are highly associated with VEGFR-TKIs, emphasizing the importance of screening for the TEE risks during VEGFR-TKI therapy.
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Tang et al. (2025) conducted an observational in Cancer (Adverse events associated with VEGFR-TKIs) (n=90,206). Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) vs. Background frequency of adverse events in the FAERS database was evaluated on Signal of disproportionate reporting (SDR) for thromboembolic events (ROR 3.29, 95% CI 3.03-3.57). Lenvatinib exhibited the strongest signal for thromboembolic events among VEGFR-TKIs, with a reporting odds ratio of 3.29 compared to the background database frequency.
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