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Hepatocellular Carcinoma Treated with Radiofrequency Ablation with or without Ethanol Injection: A Prospective Randomized Trial¹

¹ From the Department of Hepatobiliary Surgery, Cancer Centre of Sun Yat-Sen University, 651 Dongfeng Rd East, Guangzhou 510060, China (Y.J.Z., H.H.L., M.S.C., R.P.G., J.Q.L., Y.Z., Y.Q.Z.); State Key Laboratory of Oncology in Southern China, Guangzhou, China (Y.J.Z., M.S.C., R.P.G., J.Q.L., Y.Z., Y.Q.Z.); and Department of Surgery, the Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR, China (W.Y.L.). Received May 11, 2006; revision requested July 11; revision received August 28; accepted September 28; final version accepted January 2, 2007. Supported by a grant of Sciences and Technology Committee of Guangdong Province, 2002 China and Sciences and Technology Committee of Guangzhou City, China. Address correspondence to M.S.C. (e-mail: Chminsh{at}mail.sysu.edu.cn).

Purpose: To prospectively evaluate whether use of combined radiofrequency ablation (RFA) and percutaneous ethanol injection (PEI) results in better survival compared with use of RFA alone in patients with hepatocellular carcinoma.

Materials and Methods: This study was local ethical committee approved; all patients gave written informed consent. One hundred thirty-three patients were randomly assigned to undergo RFA-PEI (n = 66; 57 men, nine women; mean age, 53.3 years; age range, 32–73 years) or RFA alone (n = 67; 58 men, nine women; mean age, 52.2 years; age range, 33–74 years). Patients with viable tumors at computed tomography (CT) 4 weeks after treatment received additional treatment. Overall survival rates were calculated and 3-year survival rates were compared with life-table and Mantel-Haenszel analyses, respectively. Survival curves were constructed and compared by using Kaplan-Meier and log-rank tests, respectively. The relative prognostic significance of variables in predicting overall survival and the time to tumor recurrence or metastasis were assessed with multivariate Cox proportional hazards regression and logistic regression analyses, respectively.

Results: One-, 2-, 3-, 4-, and 5-year overall survival rates were 95.4%, 89.2%, 75.8%, 63.3%, and 49.3%, respectively, with RFA-PEI and 89.6%, 68.7%, 58.4%, 50.3%, and 35.9%, respectively, with RFA alone. The survival curve for the RFA-PEI group was significantly better than that for the RFA-only group (P = .04). The survival curve for the RFA-PEI group was better than that for the RFA-only group with 3.1–5.0-cm tumors (P = .03) but not for those with 3.0 cm or smaller (P = .44) or 5.1–7.0-cm (P = .70) tumors. Overall tumor recurrence was lower with RFA-PEI (23 patients) than with RFA alone (33 patients, nonsignificant difference). Local recurrence was significantly lower with RFA-PEI (four patients) than with RFA alone (14 patients, P = .012). Tumor diameter proved to be the only significant prognostic factor for overall recurrence and intrahepatic recurrence. Treatment type and tumor size were significant prognostic factors for local recurrence.

Conclusion: RFA-PEI facilitated better local tumor control and long-term survival compared with RFA alone.

© RSNA, 2007

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