Hepatocellular carcinoma treated with radiofrequency ablation with or without ethanol injection: a prospective randomized trial.
OBJECTIVE
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.


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.


CONCLUSIONS
RFA-PEI facilitated better local tumor control and long-term survival compared with RFA alone.
Zhang
Yao-Jun
YJ
Department of Hepatobiliary Surgery, Cancer Centre of Sun Yat-Sen University, 651 Dongfeng Rd East, Guangzhou 510060, China.
Liang
Hui-Hong
HH
Chen
Min-Shan
MS
Guo
Rong-Ping
RP
Li
Jin-Qing
JQ
Zheng
Yun
Y
Zhang
Ya-Qi
YQ
Lau
Wan Y
WY
D000328:Adult; D000368:Aged; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy / Q000601:surgery*; D017115:Catheter Ablation; D003131:Combined Modality Therapy; D000431:Ethanol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008111:Liver Function Tests; D008113:Liver Neoplasms / Q000188:drug therapy / Q000601:surgery*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D016016:Proportional Hazards Models; D011446:Prospective Studies; D015996:Survival Rate; D036542:Tomography, Spiral Computed; D016896:Treatment Outcome
D000431:Ethanol