Hepatocellular Carcinoma With Portal Vein Tumor Thrombus Treated With Transarterial Chemoembolization Combined With Sorafenib Versus Transarterial Chemoembolization Combined With 125 Iodine Implantation:A Prospective,Multicenter,Controlled Study

Purpose:Hepatocellular carcinoma（HCC）is one of the most common causes of death from cancer worldwide.It is easy to invade the portal vein,and form a portal vein tumor thrombus（PVTT）.According to Barcelona Clinic Liver Cancer staging system,BCLC stage C is accompanied with portal vein tumor thrombosis,and the currently recommended first-line treatment for advanced HCC is targeted therapy with sorafenib.The combined use of sorafenib and transarterial chemoembolization has been confirmed to bring more benefits to patients than the use of sorafenib alone,and the literature also reported that TACE combined with ¹²⁵I implantation improves the survival of such patients.But for advanced HCC patients with PVTT,whether ¹²⁵I implantation combined with TACE is more effective remains inconclusive.In this study,we evaluated the efficacy and safety of TACE combined with sorafenib versus TACE combined with ¹²⁵I implantation for advanced HCC with type Ⅱ PVTT.Material and Methods:Since January 2017,all patients who were diagnosed with advanced HCC and type Ⅱ PVTT at the Affiliated Cancer Hospital of Zhengzhou University,Henan Provincial People’s Hospital,Huaihe Hospital Affiliated to Henan University and Anyang cancer hospital who met the enrollment criteria were divided into two groups based on the patients’requirements:TACE+sorafenib group,that is,sorafenib group,and TACE+¹²⁵I implantation group,that is,¹²⁵I implantation group.In this study,180 patients are expected to be enrolled,including 60 patients in sorafenib group and 120 patients in¹²⁵I implantation group.Basic clinical data and related complications after treatment of all enrolled patients were counted,6-month,12-month,18-month survival rate and median survival time of the patients were calculated,survival curves were drawn by the Kaplan-Meier method,and prognostic factors affecting the patients’survival were analyzed.Result:A total of 127 patients were enrolled until December 2018,including 55 in the sorafenib group and 72 in the particle implantation group,of whom 3 patients in the sorafenib group were lost to follow-up and 1 patient in the ¹²⁵I implantation group withdrew.The objective response rate of the inhepatic lesions and PVTT in the ¹²⁵I implantation group was higher than the sorafenib group（P<0.05）.The 6-month,12-month,and 18-month survival rates of the sorafenib group were 61.5%,12.4%,and 0%,respectively;the 6-month,12-month,and 18-month survival rates of the ¹²⁵I implantation group were 80.3%,51.9%,and 28.6%,respectively.The median survival time of the sorafenib group and the ¹²⁵I implantation group was 8.3 months and 13.8months,respectively（χ²=24.204,P<0.001）.In subgroup analyses of type Ⅱa and Ⅱb PVTT,the median survival time of the patients with type Ⅱa PVTT in the sorafenib group and the ¹²⁵I implantation group was 9.3 and 17.5 months,respectively（χ²=31.288,P<0.001）.The median survival time of the patients with type Ⅱb PVTT in the sorafenib group and the ¹²⁵I implantation group was 4.0 and 7.1 months,respectively（χ²=6.636,P=0.010）.The results of multivariate analysis showed that PVTT subtypes（Ⅱa/Ⅱb）and treatment methods(TACE combined with sorafenib and TACE combined with ¹²⁵I implantation)are independent prognostic factors affecting patients’survival（P<0.05）.Conclusion:Compared with TACE combined with sorafenib,TACE combined with ¹²⁵I implantation can significantly improve the survival time of HCC patients with type Ⅱ PVTT,and has fewer complications.The prognosis of patients with type Ⅱa PVTT is better than that of patients with type Ⅱb PVTT.