Clinical outcomes of sorafenib treatment in patients with metastatic hepatocellular carcinoma who had been previously treated with fluoropyrimidine plus platinum-based chemotherapy.

OBJECTIVES: There has been no report on sorafenib therapy in patients with metastatic hepatocellular carcinoma (HCC) who had been treated with systemic chemotherapy. The objectives of this analysis were to investigate efficacy and safety of sorafenib in these patients and to elucidate risk factors associated with clinical outcomes.

METHODS: We analyzed patients with metastatic HCC who were treated with sorafenib after failure of fluoropyrimidine plus platinum-based chemotherapy between April 2007 and December 2008.

RESULTS: Twenty-four patients (male, 79.2%) were included. Median age was 53 years. Chronic hepatitis B was the predominant cause of HCC (79.2%), followed by chronic hepatitis C (4.2%) and alcohol (4.2%). Twenty patients (83.3%) were Child-Pugh A and 4 patients (16.7%) were Child-Pugh B. Median follow-up duration was 11.1 months. No objective response was observed. Fourteen patients (58.3%) had stable disease. The disease control rate was 58.3%. Median progression-free survival was 2.3 months (95% confidence interval, 0.5-4.1) and overall survival was 7.1 months (95% confidence interval, 3.5-10.7). Grade 3 neutropenia was observed in 1.4% and grade 3 anemia in 1.4%. Grade 3 or 4 nonhematologic toxicities were hand-foot syndrome (16.7%), skin rash (8.3%), diarrhea (4.2%), headache (4.2%), and fatigue (4.2%). Four patients (16.7%) discontinued the therapy because of toxicities.

CONCLUSIONS: Sorafenib had modest efficacy and tolerable toxicity in patients with metastatic HCC who had received fluoropyrimidine plus platinum-based chemotherapy.