Combination therapy of intra-arterial 5-fluorouracil and systemic pegylated interferon α-2b for advanced hepatocellular carcinoma.
BACKGROUND
This study evaluated the efficacy of combined 5-fluorouracil (5-FU) and pegylated interferon (PEG-IFN) α-2b in patients with advanced hepatocellular carcinoma (HCC).


METHODS
Fifty patients with portal vein tumor thrombosis were enrolled. Of these, 21 patients were treated using subcutaneous administration of PEG-IFNα-2b and intra-arterial infusion of 5-FU (5-FU/PEG-IFN group), 12 patients were treated using intramuscular administration of IFNα-2b and intra-arterial infusion of 5-FU (5-FU/IFN group), and 17 patients received intra-arterial infusion chemotherapy with lipiodol-cisplatin (CDDP) suspension (CDDP group).


RESULTS
The objective early response rate was significantly higher in the 5-FU/PEG-IFN group than in the 5-FU/IFN or CDDP groups (71.4 vs. 8.3% and 17.6%, respectively; P < 0.0001). Cumulative survival rates at 6 and 12 months were 83.8 and 77.8% in the 5-FU/PEG-IFN group, 60.8 and 16.2% in the 5-FU/IFN group, and 58.4 and 12.5% in the CDDP group, respectively. The cumulative survival rate was significantly higher in the 5-FU/PEG-IFN group than in the other 2 groups (P = 0.0272). Serious complications and treatment-related deaths were not observed in any of the 3 groups.


CONCLUSIONS
Although a prospective randomized controlled trial using a larger population of patients with advanced HCC is needed to evaluate combination therapy with 5-FU and PEG-IFNα-2b, this new combination therapy may be useful for patients with advanced HCC.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Iwate Medical University, Uchimaru 19-1, Morioka, Iwate 020-8505, Japan. kaz-k@yc4.so-net.ne.jp
Kazuhiro
K
Kasai
Akira
A
Ushio
Yukiho
Y
Kasai
Kei
K
Sawara
Yasuhiro
Y
Miyamoto
Kanta
K
Oikawa
Hidekatsu
H
Kuroda
Yasuhiro
Y
Takikawa
Kazuyuki
K
Suzuki
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011994:Recombinant Proteins; D015996:Survival Rate; D016896:Treatment Outcome
D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b; D002945:Cisplatin; D005472:Fluorouracil