PE-085: A Randomized, Prospective, Comparative Study about Effects and Safety of Sorafenib vs. Hepatic Arterial Infusion Chemotherapy for Advanced Hepatocellular Carcinoma Patients with Portal Vein Tumor Thrombosis

Aims: The treatment responses of advanced hepatocellular carcinoma( HCC) with portal vein tumor thrombosis(PVTT) were not acceptable and treatment modalities were limited. So, we compared effects and safety of sorafenib vs. hepatic arterial infusion chemotherapy( HAIC). Methods: We prospectively collected data of 58 advanced HCC with PVTT patients whose Child-Turcotte-Pugh(CTP) score range 5 to 7 in 6 university hospitals from January 2013 to Oct 2015. Each twenty nine patients were treated with sorafenib or HAIC. Results: 1. The mean age was 60.2±8.4 years old and 89.7% of the patients were male. Causes of HCC were HBV (67.3%), HCV (8.6%), alcohol (19.0%) and others (5.2%). CTP class A was 89.7%, modified Union for International Cancer Control (mUICC) stage IVa was 63.8%, tumor diameter >10cm was 55.2%, multiple tumor was 60.3%, infiltrative type was 56.9%, main PVTT was 63.8%, median AFP value was 240.4 ng/ml. 2. 29 patients were enrolled to each groups. Baseline characteristics( sex, mean age, cause of HCC, mUICC stage, size of tumor, number of tumor, type of tumor(nodular, massive, infiltrative, diffuse), location of PVTT(main, main+branch, branch). CTP class, median value of AFP) has no significant difference between two groups. 3. The objective response rate was 38.1% in HAIC and 4.5% in sorafenib group (p=0.003). In univariate analysis, treatment modality, main portal vein invasion, objective response, massive tumor type were significant prognostic factors of overall survival (p=0.012, 0.046, 0.011, 0.041) and treatment modality, tumor number, massive tumor type were significant prognostic factors of time to progress (p=0.004, 0.043, <0.01). In multivariate analysis, objective response was a significant prognostic factor of overall survival (p=0.048) and treatment modality was a significant prognostic factor of time to progress (p=0.016). 4. Major complications were neutropenia (6.9%, more than grade 3) and catheter-related complication (3.4%) in HAIC group, hand-foot syndrome (20.7%) and diarrhea (3.4%) in sorafenib group. Conclusions: For treatment of advanced HCC with PVTT patient, HAIC can be a valuable treatment modality like as sorafenib and more large size of study is needed.