Abstract
Pravastatin has demonstrated anti-tumor activity in preclinical and clinical studies. This multicentric randomized double-blind placebo-controlled phase II study (NCT01418729) investigated the efficacy and safety of sorafenib + pravastatin combination on the overall survival (OS) and time to progression (TTP) of patients with advanced hepatocellular carcinoma (aHCC). A total of 31 patients were randomized. Median OS did not differ between both groups (12.4 months for the sorafenib + pravastatin group vs. 11.6 months for the control group). Of note, however, the radiological TTP was higher in patients treated with sorafenib + pravastatin than in the control group (9.9 months vs. 3.2 months; p = 0.008). Considering all the study population, the presence of portal vein thrombosis (PVT) was associated with worse OS, being lower in patients with PVT compared to patients without PVT (6.3 months vs. 14.8 months; p = 0.026). Data also showed a decrease in OS in patients with vascular invasion (VI) compared to patients who did not present it (6.3 months vs. 14.8 months; p = 0.041). The group of patients without dermatological events (DE) showed lower OS (6.9 months vs. 14.5 months; p = 0.049). In conclusion, combination of sorafenib + pravastatin was safe and well-tolerated, prolonging the TTP of patients with aHCC but not improving the OS compared to sorafenib + placebo. The absence of PVT and VI and the development of DE are positive prognostic factors of sorafenib response.
Highlights
Hepatocellular carcinoma (HCC) is the most common liver cancer worldwide [1,2], the sixth most common neoplasm, and the third main cause of cancer-related death [3]
The majority of HCCs develop in patients with underlying chronic liver disease and the main risk factors are the presence of cirrhosis, hepatitis B or C virus (HBV or HCV) infection, chronic alcohol abuse, metabolic syndrome, non-alcoholic fatty liver disease (NAFLD) and aflatoxin exposure [1,2]
90% of the patients were Child A, 77% BCLC C, 42% presented with vascular invasion (VI), and 35% with portal vein thrombosis (PVT), in parallel with approximately
Summary
Hepatocellular carcinoma (HCC) is the most common liver cancer worldwide [1,2], the sixth most common neoplasm, and the third main cause of cancer-related death [3]. Most patients are commonly diagnosed with unresectable HCC due to advanced-stage disease, high-risk comorbidities, or resource limitations [7]. For these patients, systemic therapy is indicated [7], and sorafenib has been the standard of care in first-line treatment and is currently widely used for the treatment of patients with advanced HCC (aHCC) [8]
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