Second interim analysis of Global Investigation of Therapeutic Decisions in Unresectable HCC and of its Treatment with Sorafenib (GIDEON): U.S. versus global perspective on patient and disease characteristics, treatment history, and sorafenib use.

Abstract

e14581 Background: GIDEON is a global, prospective, noninterventional study of patients (pts) treated with sorafenib (SOR) for unresectable hepatocellular carcinoma (uHCC). Regions evaluated included US, Europe, Japan, Asia Pacific, and Latin America. Using data from the second interim analysis, we compare safety and efficacy of sorafenib in US pts with the entire (global) study population. Methods: Eligible pts had uHCC and were treated with SOR. Demographics, disease etiology, treatment history, and SOR dosing were compared in a descriptive, preplanned subgroup analysis. Results: The safety population comprised 1571 pts. In the 313 US pts, hepatitis B was less common (18% vs 37% global), but hepatitis C was more frequent (53% vs 32% global) (Table). Rate of alcoholic liver disease was higher in US pts (41% vs 29% global). At start of SOR, fewer US pts had BCLC stage C-D disease (49% vs 60% global), but more US pts were Child-Pugh (CP) B or C status (38% vs 25% global) (Table). Rates of prior surgery and locoregional treatment (LRT) were similar in US (11% and 49%, respectively) and global pts (19% and 55%, respectively). US pts received fewer TACE procedures (≥3 treatments: 13.8% vs 38.9% global); most (59%) TACE-treated pts in the US received 1 treatment. In US vs global pts, median time from prior surgery to start of SOR was 10 months (range 1-61) vs 14 months (range 1-181) and median time from last TACE to start of SOR was 3.2 months vs 3.1 months. Conclusions: Disease characteristics and treatment patterns differ in the US and global GIDEON populations. Although its limitations as an observational study must be considered, GIDEON is a valuable repository of data reflecting real-world practices in a variety of regions and pt types. [Table: see text]