Combination therapy with S-1 and pegylated interferon alpha for advanced hepatocellular carcinoma.
OBJECTIVE
There are currently no effective treatments for patients with advanced hepatocellular carcinoma (HCC) with vascular invasion or extrahepatic metastases. We evaluated the efficacy and safety of combination therapy with S-1 and pegylated interferon (PEG-IFN)-alpha for advanced HCC.


METHODS
A total of 22 patients received combination therapy with S-1 and PEG-IFN. One cycle of the combination therapy consists of oral S-1 (80 mg/m(2)) administration and subcutaneous PEG-IFN injection (PEG-IFN-alpha-2a 90 microg weekly or PEG-IFN-alpha-2b 50 microg weekly) for 4 weeks with 1- to 2-week intervals.


RESULTS
One patient was evaluated as complete response, 6 as partial response, 8 as stable disease, and 6 as progressive disease. One patient was not evaluable because therapy had to be discontinued as a result of jaundice. The median survival time was 15.3 months (95% CI: 4.4-26.2 months). The 1- and 2-year survival rates were 54.9 and 36.6%, respectively. The overall response rate was 31.8% and the disease control rate was 68.2%. Grade 3 neutropenia (18.2%), leukopenia (9.1%), anemia (9.1%), and thrombocytopenia (18.2%) were observed. Grade 4 toxicities were not observed.


CONCLUSIONS
Combination therapy with S-1 and PEG-IFN is effective and feasible, and is therefore a promising regimen for advanced HCC.
Ueshima
Kazuomi
K
Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka-Sayama, Japan.
Kudo
Masatoshi
M
Nagai
Tomoyuki
T
Tatsumi
Chie
C
Ueda
Taisuke
T
Takahashi
Shunsuke
S
Hatanaka
Kinuyo
K
Kitai
Satoshi
S
Ishikawa
Emi
E
Inoue
Tatsuo
T
Hagiwara
Satoru
S
Minami
Yasunori
Y
Chung
Hobyung
H
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D018450:Disease Progression; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage*; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011994:Recombinant Proteins; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D004338:Drug Combinations; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; C079198:S 1 (combination); D005641:Tegafur; D011092:Polyethylene Glycols; D010094:Oxonic Acid; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a