Combination therapy with transarterial chemoembolization and interferon-alpha compared with transarterial chemoembolization alone for hepatitis B virus related unresectable hepatocellular carcinoma.
OBJECTIVE
The present study was carried out to test the hypothesis that interferon-alpha (IFN-alpha) treatment would reduce or postpone the recurrence rate and improve the overall survival rate in patients after transarterial chemoembolization (TACE) treatment of hepatitis B virus (HBV) related unresectable hepatocellular carcinoma (HCC).


METHODS
216 patients with unresectable HBV-related HCC were randomized into a TACE group and a TACE-IFN group, each group had 108 patients. In the TACE-IFN group, patients received IFN-alpha1b at a dose of 3 million units (mu) three times a week by intramuscular injection one week after/before TACE treatment, for 48 weeks.


RESULTS
The median disease-free survival in the TACE-IFN treatment group was 23.6 months (95% CI: 21.4-25.8) and 20.3 months (95% CI: 15.8-24.8) in the TACE group (P = 0.027). The disease free rate at 24 months in the TACE group was lower than in the TACE-IFN group (39.8% vs 59.3%, P = 0.004). The median overall survival was 29 months (95% CI: 27.5-32.1) in the TACE-IFN group and 26 months (95% CI: 20.1-31.9) in the TACE group (P = 0.003). The 2-year overall survival in the TACE-IFN group was higher than in the TACE group (72.2% vs 52.8%, P = 0.003).


CONCLUSIONS
IFN-alpha treatment reduced recurrence and improved the survival of patients after TACE treatment of HBV-related HCC, with acceptable toxicities.
Li
Maoquan
M
Department of Interventional Radiology, Shanghai 10th People Hospital, Medical School of Tongji University, Shanghai, China. drmaoquan.li@gmail.com
Lu
Chenhui
C
Cheng
Jie
J
Zhang
Jiaxing
J
Cao
Chuanwu
C
Xu
Jiahua
J
Xu
Jichong
J
Pan
Hui
H
Zhong
Baoliang
B
Tucker
Steven
S
Wang
Daoyuan
D
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy / Q000401:mortality / Q000628:therapy* / Q000821:virology; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005780:Gelatin / Q000008:administration & dosage; D006509:Hepatitis B / Q000150:complications* / Q000401:mortality; D006801:Humans; D007273:Injections, Intramuscular; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D007459:Iodized Oil / Q000008:administration & dosage; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy* / Q000821:virology; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000970:Antineoplastic Agents; D016898:Interferon-alpha; D007459:Iodized Oil; D005780:Gelatin; D002945:Cisplatin