Long-term Outcomes of Transcatheter Arterial Chemoembolization Combined With Radiofrequency Ablation as an Initial Treatment for Early-Stage Hepatocellular Carcinoma.

Importance: The long-term outcomes of transcatheter arterial chemoembolization (TACE) combined with radiofrequency ablation (RFA) are not determined.

Objective: To report the long-term outcomes of TACE-RFA.

Design, Setting, And Participants: This cohort study analyzed long-term follow-up data from a phase 3 randomized clinical trial of adults with early HCC conducted from October 2006 to June 2009. Participants were randomly assigned to the TACE-RFA group or the RFA group in a 1:1 ratio and followed up approximately 6 years after the trial was closed. Data analysis was performed March 2020.

Exposure: In the TACE-RFA group, TACE was performed first, and RFA was done 2 weeks later.

Main Outcomes And Measures: Overall survival (OS) and recurrence-free survival (RFS).

Results: Of 189 patients who were included (mean [SD] age, 54.3 [12.0] years; 146 [77.2%] men), 94 and 95 patients were assigned to the TACE-RFA group and RFA group, respectively, with their baseline characteristics well matched. Three patients in each group were lost to follow-up. The 5-year and 7-year OS rates for the TACE-RFA group vs the RFA group were 52.0% and 36.4% vs 43.2% and 19.4%, respectively (hazard ratio [HR], 0.55; 95% CI, 0.39-0.78; P = .001). The 5-year and 7-year RFS rates for the TACE-RFA group vs the RFA group were 41.4% and 34.5% vs 27.4% and 18.1%, respectively (HR, 0.66; 95% CI, 0.49-0.89; P = .007). On subgroup analysis comparing patients who had tumors larger than 3 cm with those who had tumors 3 cm or smaller, the OS and RFS survival rates in the TACE-RFA group (HR, 3.20; 95% CI, 1.91-5.35, P < .001) were significantly better than those in the RFA group (HR, 2.03; 95% CI, 1.30-3.17; P = .002).

Conclusions And Relevance: In this cohort study, combined RFA and TACE was associated with better survival than RFA alone on long-term follow-up. Patients with tumors 3 cm or smaller did not benefit as well as patients with tumors larger than 3 cm from the combined treatment.