Sorafenib: in hepatocellular carcinoma

Sorafenib is an orally active multikinase inhibitor with anti-tumour activity. It was recently approved in the US and the EU for the treatment of patients with hepatocellular carcinoma. Oral sorafenib 400 mg twice daily significantly improved survival in patients with advanced hepatocellular carcinoma in the randomized, double-blind, multicentre, phase III SHARP trial (n = 602); the median duration of survival was 10.7 months with sorafenib and 7.9 months with placebo. In addition, the median time to progression was significantly longer in patients receiving sorafenib than in those receiving placebo (5.5 vs 2.8 months). Combination therapy with oral sorafenib 400 mg twice daily and intravenous doxorubicin has potential in the treatment of patients with advanced hepatocellular carcinoma, according to the results of a randomized, double-blind, phase II study (n = 96). Although the addition of sorafenib to doxorubicin did not significantly delay the time to progression, the median durations of overall survival and progression-free survival were significantly longer with sorafenib plus doxorubicin than with doxorubicin alone. Monotherapy with oral sorafenib 400 mg twice daily was generally well tolerated in patients with advanced hepatocellular carcinoma, with a manageable adverse event profile.