Increased survival in hepatocellular carcinoma with iodine-125 implantation plus radiofrequency ablation: a prospective randomized controlled trial.

BACKGROUND & AIMS:The purpose of this study was to evaluate whether use of combined radiofrequency ablation (RFA) and percutaneous iodine-125 ((125)I) seed implantation results in better progression-free survival compared with the use of RFA alone in patients with hepatocellular carcinoma. METHODS:136 patients were randomly assigned to undergo HCC treatment with RFA and percutaneous iodine-125 seed implantation (RFA-(125)I, n=68) or RFA-only (n=68). A total of 91 patients had hepatitis B viral infection in both groups. Rates of tumour recurrence and overall survival were evaluated. RESULTS:The probabilities of recurrence at 1-, 3-, and 5-years were 4.5%, 22.1%, and 39.8% in the RFA-(125)I group; and 14.8%, 35.3%, and 57.4% in the RFA-only group, respectively. The recurrence rate in the RFA-(125)I group was significantly lower than in the RFA-only group (HR, 0.508; 95% CI, 0.317-0.815; p=0.004 by log-rank test). Local and intrahepatic recurrence was significantly lower in the RFA-(125)I group than in the RFA-only group (7.3% vs. 22.0%, p=0.012 by log-rank test; 17.6% vs. 32.3%, p=0.041 by log-rank test). The probabilities of survival at 1-, 3-, and 5-years were 100%, 86.7%, and 66.1% in the RFA-(125)I group and 95.6%, 75.0%, and 47.0% in the RFA-only group, respectively. The survival rate in the RFA-(125)I group was significantly better than in the RFA-only group (HR, 0.502; 95% CI, 0.313-0.806; p=0.003 by log-rank test). Cox regression model indicated that the treatment group and tumour size were both recurrence-related and overall survival-related prognostic factors. CONCLUSIONS:There were significant differences in overall survival and cumulative recurrence between RFA-(125)I and RFA-only for patients with small HCCs (⩽3 cm). Treatment with RFA-(125)I facilitated better local and intrahepatic tumour control and long-term survival compared with treatment of RFA alone. ClinicalTrials.gov Identifier: NCT01717729.