Sunitinib in patients with advanced hepatocellular carcinoma after progression under sorafenib treatment.

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.