Tolerance and outcome of patients with unresectable hepatocellular carcinoma treated with sorafenib.

ABSTRACT

BACKGROUND: Sorafenib is the standard treatment for patients with an advanced stage of hepatocellular carcinoma (HCC). The aims of this study were (i) to evaluate the tolerance and survival of sorafenib-treated patients, in a nonselected population, especially in Child-Pugh B patients; and (ii) to identify potential prognostic factors of survival. PATIENTS AND METHODS: From April 2007 to December 2008, 50 patients received sorafenib for advanced HCC. Seventeen (34%) were Child-Pugh B patients. We recorded adverse events and the duration of treatment and survival. For 34 patients with histopathologically proven HCC, immunophenotypical analysis was carried out using antibodies against cluster differentiation 34, vascular endothelial growth factor, phosphorylated ERK, cytokeratin 19, and phosphorylated stat3. RESULTS: Patients with Child-Pugh B cirrhosis had a more advanced stage of the disease compared with Child-Pugh A patients. The occurrence of adverse events was similar in Child-Pugh A and Child-Pugh B patients. Duration of treatment until discontinuation for bad tolerance was lower in Child-Pugh B patients (1.8 vs. 5 months, P=0.02). Survival of Child-Pugh A patients was higher compared with Child-Pugh B patients (8.9 vs. 2 months, P=0.004). Barcelona Clinic Liver Cancer stage, Eastern Cooperative Oncology Group Performance Status, portal vein impairment, extra-hepatic spread, and alpha-foetoprotein were also prognostic factors. In multivariate analysis, the sole factor associated with survival was the Barcelona Clinic Liver Cancer stage. None of the immunohistological markers used was associated with tolerance and survival. CONCLUSION: Occurrence of adverse events is similar in Child-Pugh A and Child-Pugh B patients. Nevertheless, the survival of Child-Pugh B patients is very low. Whether liver function or tumor spread is responsible for mortality is unclear. Opportunity of treatment for Child-Pugh B patients is questionable. The immunophenotype of tumoral tissue was not predictive of survival.