Sorafenib in Advanced Hepatocellular Carcinoma Hypertension as a Potential Surrogate Marker for Efficacy

Background: Advanced hepatocellular cancer (HCC) is an incurable disease with limited options for systemic treatment. Sorafenib was approved for advanced HCC based on trials in patients with Child-Pugh class A. We reviewed our experience retrospectively in patients with HCC who were treated with sorafenib with a focus on Child-Pugh B (CP-B) liver cirrhosis and effect of hypertension (HTN) on survival. Methods: We retrospectively reviewed medical charts of patients with documented advanced HCC who received sorafenib since 2007. Survival data were plotted according to Child-Pugh class and HTN. Results: Results of 41 patients 39% had CP-B. Eighty-five percent were male and 67% had HCC due to viral hepatitis. Fifty-six percent received localized treatment before sorafenib. Five percent had a partial response and 39% had stable disease. Time to progression and overall survival (OS) for all patients were 3.2 and 6.2 months, respectively. Time to progression and OS were 4 and 8.4 months in Child-Pugh class A patients and 2 and 3.2 months in CP-B patients, which were statistically significant. Patients who had documented HTN while on treatment according to Common Terminology Criteria for Adverse Events version 3.0 had significantly better OS (18.2 vs. 4.5 mo; P = 0.016). Conclusions: Development of HTN with sorafenib seems to be associated with a favorable effect on prognosis. Future trials should examine this observation.