Sunitinib in Patients with Advanced Hepatocellular Carcinoma after Progression under Sorafenib Treatment

Abstract

Objective: To evaluate the safety and efficacy of sunitinib in patients with advanced hepatocellular carcinoma (HCC) after progression under sorafenib treatment. Methods: Sunitinib was administered at 37.5 mg daily (4-weeks-on/2-weeks-off schedule) after progression under sorafenib treatment. Adverse events (AEs) were assessed using NCI-CTCAE v3.0, and tumor response was evaluated according to RECIST. Data were analyzed retrospectively. Results: Eleven patients with metastatic disease were treated. Seven patients (64%) presented with no liver cirrhosis, including 3 patients with a history of liver transplantation. The first radiological follow-up showed stable disease in 40% of patients after marked radiological progression under sorafenib. The median time to progression was 3.2 months. Treatment was discontinued due to radiological progression (n = 9) or AEs (n = 2; hemorrhages) in all patients after 3.5 months. The median overall survival was 8.4 months. All patients with Child-Pugh class B liver cirrhosis suffered a clinical deterioration of liver function and died within 4 months due to tumor progression. Conclusions: Sunitinib provided modest antitumor activity in patients with advanced HCC after progression under sorafenib treatment. Patients with Child-Pugh class B liver cirrhosis might not receive a clinical benefit from this second-line approach. Hemorrhagic complications may represent a clinically relevant problem of sunitinib in patients with advanced HCC.