This is the report of the PRODIGE-11 trial comparing the clinical outcomes of sorafenib-pravastatin combination versus sorafenib alone in patients with advanced HCC. 323 patients were randomly assigned to sorafenib-pravastatin combination (n=162) or sorafenib alone (n=161). After a median follow-up of 35 months, no difference in median overall survival (OS) (10.7 months vs 10.5 months; HR 1.00; p=0.975) nor in secondary efficacy endpoints was observed between treatments arms. In the multivariate analysis, the only prognostic factor for OS was the CLIP score. The main toxicity was diarrhea (severe in 11% vs 8.9%).
(Jouve JL et al. – Journal of Hepatology, 21 May 2019)