Prospective randomized trial of hepatic artery chemotherapy with cisplatin and doxorubicin, with or without lipiodol in the treatment of advanced stage hepatocellular carcinoma.

Purpose: This randomized study assessed the responses in hepatocellular carcinoma (HCC) to hepatic arterial doxorubicin plus cisplatin, with or without lipiodol.

Patients And Methods: Patients with unresectable and biopsy-proven HCC were treated with doxorubicin (30 mg/m) plus cisplatin (100 mg/m) without (Solution) or with (Lipiodol) emulsification every 2 months till tumor progression. Primary end point was response.

Results: Partial response rate was 56.8% for Lipiodol and 47% for Solution, P=0.48. Responses were evaluated as tumor size changes without vascularity assessments, due to the lipiodol. There were no complete responses. Survival at 6,12,18, and 24 months was 65, 32, 27, and 10.8% for Lipiodol patients and 70.6, 26.6, 8.8, and 8.8 for Solution patients. Of the total 71 enrolled and evaluable patients, survival at 6, 12, and 18 months was 75.7, 40, and 35% for responders and 58.8, 17.6, and 0 for nonresponders. There were no clear clinical or biochemical profile differences between the 2 treatment groups or between responders and nonresponders.

Conclusions: Lipiodol conferred a minor response advantage, recorded as tumor size change, to hepatic arterial chemotherapy with doxorubicin plus cisplatin for HCC, but no survival advantage.