Objectives: Effective chemotherapy with the least toxicity is important for patients with inoperable or advanced hepatocellular carcinoma. Single use of pegylated liposomal doxorubicin has been reported to be safe and effective with varying treatment response. The authors evaluate its activity in combination with capecitabine or gemcitabine as salvage therapy in these patients.
Methods: At first, intravenous administration of 30 mg/m2 pegylated liposomal doxorubicin for 60 minutes on day 1, with oral capecitabine 1500 mg twice daily from day 1 to day 14 every 4 weeks (trial A) was conducted. Following unfavorable results, a second trial (trial B) was performed to subsequent patients with the same pegylated liposomal doxorubicin schedule, but in combination with 1000 mg/m2 gemcitabine over 30 minutes on day 1 and day 8, followed by a 2-week rest.
Results: Both trials showed no objective response, with 2 patients with stable disease in each trial. In trial A, the disease control rate of all evaluative patients (complete response + partial response + stable disease) and progression-free survival of 2 responders were 20%, 164 days and 240 days versus 22%, 75 days and 73 days in trial B. The median overall survival for all patients in trials A and B were 161 days and 84 days respectively. Generally, toxicities were well managed without toxic death.
Conclusion: Pegylated liposomal doxorubicin-based combination chemotherapy with capecitabine or gemcitabine was not effective as salvage therapy in advanced hepatocellular carcinoma. Further effective systemic chemotherapy for patients with advanced hepatocellular carcinoma is warranted.