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

Abstract

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 (PS), IDs of 800/<800 mg/day were given as follows: PS ≤1: 55%/45%; PS ≥2: 44%/56%. By age, corresponding values were 57%/42% for <75 yr; 33%/67% for ≥75 yr. The incidence of AEs was similar across dose levels (Table). Conclusions: Baseline liver function, tumor stage, and etiology did not seem to have an influence on ID selection. We observed a trend toward lower ID in pts with age ≥75 yr and PS ≥2. Despite differences in average daily dose and time on drug, the safety profile for each ID was similar and dose adjustments may have contributed. Additional analyses are being evaluated to assess these and other contributing factors. Clinical trial information: NCT00812175. [Table: see text]