| Objective To investigate the clinical curative effect and safety of transcatheter arterial chemoembolization (TACE) combination sorafenib for treating advan-ced hepatocellular carcinoma.Methods Retrospective analysis180patients with advanced hepatocellular carcinoma to be eligible in Affiliated Cancer Hospital of Guangxi Medical University in July2008to June2011.90patients of TACE combination sorafe-nib were considered as treatment group, and another90patients of only TACE known as control group (The data in two groups are comparability). Treatment group:Firstly, received TACE treatment, and then the patients in treatment group used sorafenib by oral administration400mg/time, two times a day. Once again TACE treatments,3days after TACE disruption during sorafenib treatment, in order to evaluate the project safety. One time every6to8weeks with TACE, if there were not lesions in arterial phase enhancement during the review of liver CT, simply taking sorafenib can be for maintenance treatment. Control group:Simple TACE treatments, the interval of methods, drugs and treatment were the same to the treatment group. According to the evaluation of the efficacy of standard mRECIST for the evaluation of curative effect. According to ECOG score criteria for evaluation of quality of life. Every6to8weeks for a course of treatment, one time evaluation would be done. The primary endpoint of study was the time to progression (TTP), overall survival (OS) and quality of life. The secondary end point was the response rate (RR), disease control rate (DCR), AFP decline rate and side effects. All data were analyzed by SPSS16.0software, application ofx2test statistics. Survival rate using the life table method, Kaplan-Meier method was used to analyze survival curve. The differences were significant shown with P<0.05.Results1. The primary endpoints of the study:ms-time to progression (mTTP) in treatment group and control group were6.6months vs4.6months respectively, P=0.000and the ms-overall survival (mOS) in treatment group and control group were13.2months vs9.6months respectively. Treatment group mTTP, mOS were longer than control group, and the difference was significant. After2courses of treatment, quality of life in patients with stable and improving the rate were higher than that of the control group, and there was a significant difference(P=0.010).2. The secondary endpoints of the study:After2courses of treatment, the response rate in the treatment group and the control group were34.4%vs21.1%respectively,.P=0.046, the disease control rates were73.3%vs 53.3%, P=0.005, the treatment group was superior to control group. After2courses of treatment, the decreased rate of AFP more than50%in the treatment group and the control group were43.3%vs27.8%respectively(P=0.029). Obse-rving the adverse reaction, patients with hand-foot syndrome, diarrhea, rash, hypertensive in the treatment group were more than the control group, one patient presented brain hemorrhage in the treatment group, but after treatment can be relieved.Conclusion It can prolong time to progression and overall survival of advanced hepatocellular carcinoma through TACE combination sorafenib. It also improv-ed the efficiency rate, disease control rate, further to improve life quality and has good safety. |
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