Efficacy and safety of sorafenib (Sor) in patients (Pts) with advanced hepatocellular carcinoma (HCC): Subgroup analyses of the SHARP trial by baseline (BL) transaminase (ALT/AST)/α-fetoprotein (AFP) and bilirubin (bil) levels.

4051^ Background: Results of the phase III, double-blind, placebo (Pla)-controlled SHARP trial demonstrated that Sor is effective and safe for the treatment of advanced HCC. As hepatic function influences treatment options, we examined the effect of Sor on hepatic function, as indicated by bil levels, and performed subset analyses of SHARP according to BL levels of ALT/AST/AFP. Methods: Pts (N=602) were randomized 1:1 to receive Sor 400 mg bid or Pla in 6-week cycles. Endpoints included overall survival (OS), disease-control rate (DCR; defined as complete/partial response or stable disease by RECIST maintained for ≥28 days from first demonstration of response), time to progression (TTP), and safety. Pts were grouped by BL levels of ALT/AST (normal, mild, or moderate) and AFP (normal or abnormal). Bil was measured at BL and day 1 of each cycle. Results: TTP, OS, and DCR are shown. No notable differences in the safety profiles were observed between Pts with normal vs elevated ALT/AST/AFP levels. Mean BL lev...