Better Management of Adverse Events Favors Sorafenib Treatment of HCC Patients and Impact on Survival

Abstract

Introduction: Sorafenib is an orally active multikinase inhibitor approved for the treatment of advanced hepatocellular carcinoma (HCC) and is the only systemic treatment associated with a survival benefit in advanced stage. The aims of this study were to evaluate the tolerance and survival of sorafenib-treated patients, and to identify potential prognostic factors of survival. Methods: A total of 88 HCC patients treated with sorafenib from June 2010 to January 2014 were retrospectively reviewed. Tumour stage, liver function and adverse events to sorafenib were analyzed. Univariate and multivariate analysis were carried out to identify predictors of survival in patients with advanced HCC treated with sorafenib. Results: There were 64 (73%) males included in this study, with a median age of 61.16 years. Eight (91%) patients had Child-Pugh class A cirrhosis. Most patients were classified as BCLC C (82%). Hepatitis C virus was the predominant cause of HCC (68%). Sorafenib was the initial treatment modality in 43%. Median time of sorafenib therapy was 8.23 months. Overall survival in 1 year was 57.3% and 36.7% in 2 years. The median survival was 16.3 months. In the univariate analysis of the OS based on Child-Pugh score did not demonstrate a significant difference in our study (p = 0.62). The presence of dermatologic adverse event predicted a better overall survival in the multivariate analysis. Better survival was also observed in patients with AFP level <100 ng/ml in the start of sorafenib therapy (p = 0.001). Patients that used Sorafenib for ≥6 months had shown better outcome. None of the patients discontinued sorafenib because of adverse effects. Conclusions: Advanced HCC patients treated with sorafenib who experienced dermatologic adverse event and low AFP level <100 ng/ml showed better overall survival. As expected, longer sorafenib therapy (≥6 months) was associated to better survival. Even in the presence of adverse events, the use of sorafenib should be continued because the longer usage time improves survival.