Second interim analysis of GIDEON (Global Investigation of Therapeutic Decisions in Unresectable HCC and of Its Treatment with Sorafenib): Sorafenib treatment and safety in U.S. patients with Child-Pugh B status.

Abstract

282 Background: Sorafenib (SOR) is the first systemic therapy to demonstrate a survival benefit in patients (pts) with late-stage hepatocellular carcinoma (HCC). GIDEON is an ongoing, global, prospective, noninterventional study of HCC pts receiving SOR in real-life practice. We present results from the second interim analysis, describing dosing and safety of SOR in HCC pts with Child-Pugh (CP)-B status in the US. Methods: From Jan 2009 – Nov 2010, 326 pts were enrolled (n = 313, safety population) and followed ≥4 months at 92 US centers. Eligible pts had unresectable HCC and were treated with SOR. Demographics, initial dose, treatment duration (TD), dose modifications (mods), and adverse events (AE) were analyzed in pts with available CP status. Results: 119 (38%) pts were CP-A and 100 (32%) were CP-B. 94 (30%) pts were excluded (Table). Median (med) SOR dose was 580 mg/d in CP-A pts and 577 mg/d in CP-B pts. Med TD was 14.4 weeks (wks) in CP-A pts and 10.1 wks in CP-B pts. TD was <4 wks, 4-12 wks, and >12 wks in 14%, 29%, and 56% of CP-A pts, and 22%, 36%, and 39% of CP-B pts, respectively. Treatment-emergent (TE) drug-related AE (all grades) were similar between groups, but more CP-B pts discontinued SOR due to AE (Table). In CP-A and -B pts, all-grade AE were as follows: hand-foot skin reaction (HFSR) (28% vs 19%), diarrhea (28% vs 27%), and fatigue (15% vs 16%). All-grade elevations in ALT, AST, and bilirubin were 2.5%, 2.5%, and 3.4% in CP-A pts and 3%, 1%, and 4% in CP-B pts. Conclusions: These interim US data suggest that SOR safety may be similar in HCC pts with CP-A and CP-B status. Med SOR dose was similar, but med TD was shorter in CP-B pts. AEs were as expected, although HFSR may be underreported in CP-B pts. Limitations of an observational registry must be considered. [Table: see text]