Background: We performed a systematic review and meta-analysis of cardiovascular toxicities associated with sorafenib.
Patients & methods: Eligible studies included randomized Phase II and III trials of patients with solid tumors receiving daily sorafenib treatment that described the following events: hypertension, bleeding, venous thromboembolism, left ventricular dysfunction myocardial ischemia and cerebrovascular events.
Results: A total of 18 randomized clinical trials were considered eligible for the meta-analysis. Patients treated with sorafenib had a significantly increased risk of hypertension (relative risk [RR]: 2.93; 95% CI: 1.52-5.66), bleeding (RR: 2.42; 95% CI: 1.63-3.62) and left ventricular dysfunction (RR: 9.38; 95% CI: 1.24-71.22). The risk for venous thromboembolism, myocardial ischemia and cerebrovascular events was nonsignificant. Subgroup analyses showed that tumor type and treatment regimen had no effect on the RR of cardiovascular toxicities.
Conclusion: Our meta-analysis demonstrated that sorafenib is associated with a higher risk of developing all grade hypertension and bleeding compared with controls.
Keywords: bleeding; cardiovascular toxicities; hypertension; left ventricular dysfunction; meta-analysis; myocardial ischemia; sorafenib.