Clinical effect and safety of hepatic arterial infusion of cinobufotalin injection combined with lipiodol chemoembolization in treatment of Barcelona Clinic Liver Cancer stage C primary liver cancer

Objective To investigate the clinical effect and safety of hepatic arterial infusion of cinobufotalin injection combined with lipiodol chemoembolization( TACE) in the treatment of Barcelona Clinic Liver Cancer( BCLC) stage C primary liver cancer.Methods A retrospective analysis was performed for the clinical data of 82 patients with BCLC stage C primary liver cancer who were admitted to Department of TCM Oncology in Changhai Hospital from December 2010 to October 2014.According to intraoperative medication,the patients were divided into two groups.The 40 patients in the cinobufotalin group were treated with hepatic arterial infusion with cinobufotalin combined with lipiodol embolism,and the 42 patients in the control group underwent TACE with epirubicin.The objective response rate,time to progression,median survival time,and acute adverse events were compared between the two groups after a single treatment.The t- test was used for comparison of continuous data between groups,the chi- square test was used for comparison of categorical data between groups,and the Kaplan- Meier method was used for the analysis of cumulative survival rate.Results At 1.5 months after surgery,the cinobufotalin group had a significantly higher objective response rate than the control group( 27.5% vs 9.52%,χ~2= 4.429,P = 0.035).The time to progression was 2.4 months( 95% CI:1.978- 2.822) in the cinobufotalin group and 3.0 months( 95% CI:2.260- 3.740) in the control group,and there was no significant difference between the two groups( P = 0.344).The median survival time was 6.6 months( 95% CI:4.131-9.069) in the cinobufotalin group and 10.3 months( 95% CI:0.089- 20.511) in the control group,and there was no significant difference between the two groups( P = 0.132).At 5 days after surgery,the cinobufotalin group had significantly lower incidence rates of abnormal alanine aminotransferase level,white blood cell count,and platelet count,as well as adverse events including hepatalgia,abdominal distension,and nausea / vomiting than the control group( χ~2= 6.193,5.311,6.096,5.909,4.761,and 4.173,all P < 0.05).Conclusion As for patients with BCLC stage C primary liver cancer,hepatic arterial infusion of cinobufotalin injection combined with lipiodol chemoembolization has a better short- term therapeutic effect,milder adverse effects,and a similar long- term therapeutic effect compared with TACE with conventional chemotherapeutic agents.