Objective： New systemic therapies are needed to improve the prognosis of patients with advanced-stage hepatocellular carcinoma. The study was conducted to determine the efficacy and safety of viscum fraxini-2 in adva...Objective： New systemic therapies are needed to improve the prognosis of patients with advanced-stage hepatocellular carcinoma. The study was conducted to determine the efficacy and safety of viscum fraxini-2 in advanced Hepatocellular carcinoma. Methods： A phase II study with a two-stage design that enrolled a total of 120 patients with chemotherapy nai＇ve advanced hepatocellular carcinoma. The mistletoe preparation for the study is an aqueous injectable solution that contains one milliliter of viscum fraxini. Two ampoules of viscum fraxini were administered subcutaneously once weekly. Re- suits： Chronic hepatitis C virus infection was the predominant cause of liver disease （60%） in studied cases. According to the response evaluation criteria in solid tumors 24 patients （20%） achieved objective response （including 2 complete responses） and 40 patients （33.3%） achieved stable disease. The median progression free survival for all patients was 4 months （range 1-28 months; 95% CI 3.3：4.7 months）. The median overall survival for all patients was 8 months （range 1-28 months; 95% CI 6.3：9.7 months）. The median survival for patients who achieved responsive or stable disease was 16 months. The toxicity was generally mild and well tolerated, mainly in the form of local reaction and fever. There were no drug related discontinu- ation or toxic deaths. Conclusion： Viscum fraxini-2 is an effective, safe treatment for patients with advanced hepatocellular carcinoma. Further randomized controlled trials are recommended.展开更多
文摘Objective： New systemic therapies are needed to improve the prognosis of patients with advanced-stage hepatocellular carcinoma. The study was conducted to determine the efficacy and safety of viscum fraxini-2 in advanced Hepatocellular carcinoma. Methods： A phase II study with a two-stage design that enrolled a total of 120 patients with chemotherapy nai＇ve advanced hepatocellular carcinoma. The mistletoe preparation for the study is an aqueous injectable solution that contains one milliliter of viscum fraxini. Two ampoules of viscum fraxini were administered subcutaneously once weekly. Re- suits： Chronic hepatitis C virus infection was the predominant cause of liver disease （60%） in studied cases. According to the response evaluation criteria in solid tumors 24 patients （20%） achieved objective response （including 2 complete responses） and 40 patients （33.3%） achieved stable disease. The median progression free survival for all patients was 4 months （range 1-28 months; 95% CI 3.3：4.7 months）. The median overall survival for all patients was 8 months （range 1-28 months; 95% CI 6.3：9.7 months）. The median survival for patients who achieved responsive or stable disease was 16 months. The toxicity was generally mild and well tolerated, mainly in the form of local reaction and fever. There were no drug related discontinu- ation or toxic deaths. Conclusion： Viscum fraxini-2 is an effective, safe treatment for patients with advanced hepatocellular carcinoma. Further randomized controlled trials are recommended.
