Safety and efficacy of sorafenib therapy in patients with hepatocellular carcinoma: final outcome from the Chinese patient subset of the GIDEON study.

Abstract

We report data from the final analysis of the Chinese subset of the GIDEON (the Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib) study, which evaluated the safety and efficacy of sorafenib in Child-Pugh A, B and C patients with unresectable hepatocellular carcinoma (uHCC) in real-life clinical practice. Patient demographics, disease characteristics and treatment history were recorded at enrollment; dose, adverse events (AEs) and efficacy were recorded at follow-up. Of the 338 evaluable patients, 98.5% started on 800 mg/day sorafenib, regardless of their Child-Pugh status. The median treatment duration (21.1 vs. 18.8 weeks) and median overall survival (322 vs 240 days) were longer in patients with Child-Pugh A compared with the Child-Pugh B, progression-free survival were 183 vs. 208 days, respectively). AEs (all grades) were comparable in the Child-Pugh B vs A group (56.3% vs. 50.4%, respectively), moreover, the Child-Pugh B group also had comparable rates of drug-related AEs (35.4% vs. 27.2%, respectively) and serious AEs (25.0% vs. 23.0%, respectively) compared with the Child-Pugh A group. The overall dosing strategy was consistent in Chinese patients across Child-Pugh subgroups. Tolerability and safety data suggest that Child-Pugh B patients might be safely treated with sorafenib. The findings from our study showed that safety profile of sorafenib in terms of rate and type of AEs is similar to the global international GIDEON study as well as other pivotal studies.