Purpose: Sorafenib is considered a standard of care in advanced hepatocellular carcinoma (HCC). Its combination with gemcitabine, a pyrimidine analogue with limited friendly hepatic profile may prove beneficial in advanced HCC. The primary objective was to evaluate the efficacy and safety of a sorafenib and gemcitabine combination in patients with advanced HCC.
Methods: This was a non-randomized, open-label, single-arm, multi-centric Phase II study conducted in Pakistan where 30 treatment-naive patients aged between 26 and 73 years with Child-Pugh score A or B were treated with sorafenib (400 mg oral) twice daily for 16 weeks along with gemcitabine (1000 mg/m(2) intravenous) administered on day 1 and day 8 of a four-week cycle for 16 weeks.
Results: Of the 18 patients (60%) who completed all four cycles of treatment, eight patients had stable disease, two had partial response, and eight had progressive disease. There was no complete response. The most common (≥10% patients) treatment-emergent adverse events were gemcitabine-related thrombocytopenia (40%) followed by sorafenib-related hand-foot skin reaction and anorexia (33% each).
Conclusion: The efficacy of sorafenib gemcitabine combination therapy is similar to the sorafenib alone treatment. However, frequent dose adjustments due to gemcitabine-related toxicities, delays, and corrective treatments make this combination therapy unsafe in the treatment of advanced HCC.
Copyright © 2013 King Faisal Specialist Centre & Research Hospital. Published by Elsevier B.V. All rights reserved.