PURPOSE: To prospectively compare combined radiofrequency ablation and transcatheter arterial chemoembolization (TACE) with radiofrequency ablation alone for the treatment of small (< or =3 cm) hepatocellular carcinomas (HCCs). MATERIALS AND METHODS: The ethics committee of the study institution approved the study protocol. Written informed consent was obtained from all patients at enrollment. Eighty-nine patients with 93 HCC nodules 0.8-3.0 cm (mean +/- standard deviation, 1.7 cm +/- 0.5) in diameter were randomly treated with combined radiofrequency ablation and TACE (46 patients with 49 nodules) or with radiofrequency ablation alone (43 patients with 44 nodules). The patients were followed up for 9-68 months (mean +/- standard deviation, 30.4 months +/- 14.0). Rates of local tumor progression, overall survival, local progression-free survival, and event-free survival were evaluated by using the Kaplan-Meier method. RESULTS: The 1-, 2-, 3-, and 4-year rates of local tumor progression, overall survival, local progression-free survival, and recurrence-free survival were as follows: Local tumor progression rates were 14.4%, 17.6%, 17.6%, and 17.6%, respectively, in the combined treatment group and 11.4%, 14.4%, 14.4%, and 14.4%, respectively, in the radiofrequency ablation group (P = .797). Overall survival rates were 100%, 100%, 84.8%, and 72.7%, respectively, in the combined treatment group and 100%, 88.8%, 84.5%, and 74.0%, respectively, in the radiofrequency ablation group (P = .515). Local progression-free survival rates were 84.6%, 81.1%, 69.7%, and 55.8%, respectively, in the combined treatment group and 88.4%, 74.1%, 74.1%, and 61.7%, respectively, in the radiofrequency ablation group (P = .934). Event-free survival rates were 71.3%, 59.9%, 48.8%, and 36.6%, respectively, in the combined treatment group and 74.3%, 52.4%, 29.7%, and 29.7%, respectively, in the radiofrequency ablation group (P = .365). CONCLUSION:Combined radiofrequency ablation plus TACE and radiofrequency ablation alone have equivalent effectiveness for the treatment of small (< or =3 cm) HCCs, so the combination treatment may not be necessary.
RCT Entities:
PURPOSE: To prospectively compare combined radiofrequency ablation and transcatheter arterial chemoembolization (TACE) with radiofrequency ablation alone for the treatment of small (< or =3 cm) hepatocellular carcinomas (HCCs). MATERIALS AND METHODS: The ethics committee of the study institution approved the study protocol. Written informed consent was obtained from all patients at enrollment. Eighty-nine patients with 93 HCC nodules 0.8-3.0 cm (mean +/- standard deviation, 1.7 cm +/- 0.5) in diameter were randomly treated with combined radiofrequency ablation and TACE (46 patients with 49 nodules) or with radiofrequency ablation alone (43 patients with 44 nodules). The patients were followed up for 9-68 months (mean +/- standard deviation, 30.4 months +/- 14.0). Rates of local tumor progression, overall survival, local progression-free survival, and event-free survival were evaluated by using the Kaplan-Meier method. RESULTS: The 1-, 2-, 3-, and 4-year rates of local tumor progression, overall survival, local progression-free survival, and recurrence-free survival were as follows: Local tumor progression rates were 14.4%, 17.6%, 17.6%, and 17.6%, respectively, in the combined treatment group and 11.4%, 14.4%, 14.4%, and 14.4%, respectively, in the radiofrequency ablation group (P = .797). Overall survival rates were 100%, 100%, 84.8%, and 72.7%, respectively, in the combined treatment group and 100%, 88.8%, 84.5%, and 74.0%, respectively, in the radiofrequency ablation group (P = .515). Local progression-free survival rates were 84.6%, 81.1%, 69.7%, and 55.8%, respectively, in the combined treatment group and 88.4%, 74.1%, 74.1%, and 61.7%, respectively, in the radiofrequency ablation group (P = .934). Event-free survival rates were 71.3%, 59.9%, 48.8%, and 36.6%, respectively, in the combined treatment group and 74.3%, 52.4%, 29.7%, and 29.7%, respectively, in the radiofrequency ablation group (P = .365). CONCLUSION: Combined radiofrequency ablation plus TACE and radiofrequency ablation alone have equivalent effectiveness for the treatment of small (< or =3 cm) HCCs, so the combination treatment may not be necessary.