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A Randomized Controlled Trial

Bao-Quan Cheng, MD, PhD; Chong-Qi Jia, PhD; Chun-Tao Liu, MD; Wei Fan, MD; Qing-Liang Wang, MD; Zong-Li Zhang, MD, PhD; Cui-Hua Yi, MD, PhD

JAMA. 2008;299(14):1669-1677.

Context  Transarterial chemoembolization (TACE) combined with radiofrequency ablation (RFA) therapy has been used for patients with large hepatocellular carcinoma tumors, but the survival benefits of combined treatment are not known.

Objective  To compare rates of survival of patients with large hepatocellular carcinoma tumors who received treatment with TACE combined with RFA therapy (TACE-RFA), TACE alone, and RFA alone.

Design, Setting, and Patients  Randomized controlled trial conducted from January 2001 to May 2004 among 291 consecutive patients with hepatocellular carcinoma larger than 3 cm at a single center in China.

Intervention  Patients were randomly assigned to treatment with combined TACE-RFA (n = 96), TACE alone (n = 95), or RFA alone (n = 100).

Main Outcome Measures  The primary end point was survival and the secondary end point was objective response rate.

Results  During a median 28.5 months of follow-up, median survival times were 24 months in the TACE group (3.4 courses), 22 months in the RFA group (3.6 courses), and 37 months in the TACE-RFA group (4.4 courses). Patients treated with TACE-RFA had better overall survival than those treated with TACE alone (hazard ratio [HR], 1.87; 95% confidence interval [CI], 1.33-2.63; P < .001) or RFA (HR, 1.88; 95% CI, 1.34-2.65; P < .001). In a preplanned substratification analysis, survival was also better in the TACE-RFA group than in the RFA group for patients with uninodular hepatocellular carcinoma (HR, 2.50; 95% CI, 1.42-4.42; P = .001) and in the TACE-RFA group than the TACE group for patients with multinodular hepatocellular carcinoma (HR, 1.99; 95% CI, 1.31-3.00; P < .001). The rate of objective response sustained for at least 6 months was higher in the TACE-RFA group (54%) than with either TACE (35%; rate difference, 0.19; 95% CI, 0.06-0.33; P = .009) or RFA (36%; rate difference, 0.18; 95% CI, 0.05-0.32; P = .01) treatment alone.

Conclusion  In this patient group, TACE-RFA was superior to TACE alone or RFA alone in improving survival for patients with hepatocellular carcinoma larger than 3 cm.

Trial Registration  clinicaltrials.gov Identifier: NCT00479050

Author Affiliations: Departments of Gastroenterology (Drs Cheng, Liu, and Fan), Radiology (Dr Wang), Surgery (Dr Zhang), and Oncology (Dr Yi), Qilu Hospital School of Medicine, and Department of Epidemiology and Health Statistics (Dr Jia), Shandong University, Jinan, China.

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