Evaluation Of The Clinical Utility Of TACE Combined With Sorafenib In The Treatment Of Primary Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Purpose:To investigate the clinical efficacy and safety of TACE combined with sorafenib in the treatment of primary hepatocellular carcinoma(HCC)complicated with portal vein tumor thrombus(PVTT).Methods:We retrospectively analyzed 58 advanced HCC patients with portal vein tumor thrombus from April 2009 to October 2016 at The Second Affiliated hospital of Nanchang University,of which 28 cases treated with TACE combined with sorafenib as combined group,30 cases of patients with hepatic artery infusion chemotherapy and embolization(TACE)as control group.In the combined group,the oral administration of sorafenib was started at 400 mg twice daily after TACE treatment 3-5days later.follow-up these patients every 4-6 weeks,using the latest evaluation criteria for the efficacy of solid tumors m RECIST to evaluate efficacy,OS was the primary endpoint of the study,The secondary endpoints were TTP,Disease Control Rate(DCR)and Adverse Events(AE).To analyze the survival time and prognosis of patients with different PVTT types treated with TACE combined with sorafenib and TACE alone.SPSS 18.0 was used for statistical analysis.Cegorical variables with X2 test,KaplanMeier method for survival analysis,Log-rank test for single factor analysis.COX model for multivariate analysis.P<0.05 was considered as significantly changes Results:1.There were no statistically significant differences in any of the baseline characteristics.The median OS were 10.9(95% CI 8.4–13.4)months and 6.6(95%CI 5.3–7.9)months respectively,p <0.05;The median TTP in TACE-sorafenib group and TACE alone group were 5.4(95% CI 4.3–6.5)months and 3.7(95% CI 3.0–4.4)months respectively,p <0.05.2.Of the different PVTT types,the median OS of type I,type II,type III and control groups were(13.2 months vs 7.8 months,p = 0.008),(9.4 months vs6.1Month,p = 0.034),(3.5 months vs 4.2 months,p = 0.797).The mOS of theexperimental group was significantly better than that of the control group in type I and type II PVTT.There was no significant difference in mOS between the two groups of type III.3.The disease control rate of the combined group and the control group were53.6% and 26.7% respectively,p=0.04.No TACE-related deaths occurred in the treatment process,no significant adverse reaction related to two groups of TACE,sorafenib does not increase the TACE-related incidence of adverse reactions.No sorafenib-related deaths occurred in the combined group.But there are 4 patients with serious toxicity(two patient grade 3 hand-foot syndrome,one patient grade 3 diarrhea and one patient hypertension,respectively),15 patients halve the amount,which of them cannot tolerate the side effects,such as diarrhea,rash and hand-foot syndrome.Conclusions:1.It is safe and feasible for patients of HCC with PVTT to treated with TACE combined with sorafenib.Sorafenib did not increase adverse reaction rate of TACE.2.TACE combined with sorafenib can improve the overall survival and disease control rate of HCC patients with PVTT compared with TACE alone.3.Combined treatment and portal vein tumor thrombus were independent prognostic factor of mOS in HCC patients,TACE combined with sorafenib can extend OS of HCC patients.