A multi-centre randomized phase II study of nolatrexed versus doxorubicin in treatment of Chinese patients with advanced hepatocellular carcinoma

Purpose: A multi-centre randomized phase II study of single agent nolatrexe d dihydrochloride Versus doxorubicin was undertaken in Chinese patients wit h advanced hepatocellular carcinoma (HCC) to study and compare the clinical efficacy of the two drugs. Methods: Fifty-four patients with clinical or h istological diagnosis of HCC were randomized in a 2:1 ratio to receive nola trexed or doxorubicin. Nolatrexed 725 mg/m(2)/day was given by continuous i nfusion via a central venous device for 5 days and doxorubicin 60 mg/m(2) w as given as a rapid intravenous infusion every 3 weeks. Results: No objecti ve responses were observed in either treatment arm. Two patients in the nol atrexed arm and none in the doxorubicin arm had > 50% decline in serum alph a-fetoprotein. The median survival for the patients in the nolatrexed and d oxorubicin arms was 139 days and 104 days, respectively. Moderate toxicitie s including leukopenia, thrombocytopenia, mucositis and skin rash were obse rved in both treatment arms. Conclusion: Nolatrexed and doxorubicin are min imally active in the treatment of advanced HCC. Given the small sample size , no difference is observed between the two drugs.