Potential factors influencing initial sorafenib dose selection in hepatocellular carcinoma (HCC): U.S. regional analysis of GIDEON.

304 Background: GIDEON is a global, prospective, noninterventional study to evaluate sorafenib (SOR) safety under real-life practice conditions. Here we examine potential factors that may have had an impact on initial SOR dose (ID) selection in the U.S. cohort of GIDEON. Methods: Patients (pts) with unresectable HCC who were candidates for systemic therapy and for whom a decision was made to treat with SOR were eligible for inclusion. ID choice was at physician discretion. Baseline characteristics were analyzed for their potential impact on the choice of ID. Adverse events (AEs) were evaluated by ID. All results are descriptive. Results: 563 pts were valid for safety. 54% of pts received the recommended ID of 800 mg/d, 35% received 400 mg/d, and 11% other (includes 100, 200, 600 mg/d. dose). Among pts who had an ID <800 mg/d, 37% underwent a dose increase to 800 mg/d. ID did not appear to differ by baseline Child-Pugh or its components, BCLC stage, etiology, or body mass index. By ECOG performance status ...