title: Efficacy of hepatic arterial infusion chemotherapy using 5-fluorouracil and systemic pegylated interferon α-2b for advanced intrahepatic cholangiocarcinoma.
abstract: BACKGROUND
  Cholangiocarcinoma is categorized into intrahepatic cholangiocarcinoma (ICC) and extrahepatic cholangiocarcinoma (ECC). The prognosis of ICC is far worse than that of ECC. In this pilot trial, the efficacy of hepatic arterial infusion chemotherapy (HAIC) using 5-fluorouracil (5-FU) combined with subcutaneous administration of pegylated interferon (PEG-IFN) α-2b in patients with advanced ICC was evaluated.
  
  
  METHODS
  The subjects were 20 advanced ICC patients treated using subcutaneous PEG-IFNα-2b (50-100 μg on day 1 of every week, for 4 weeks) and intra-arterial infusion of 5-FU (250 mg/day for 5 h on days 1-5 of every week, for 4 weeks). One treatment cycle lasted 4 weeks. Therapy was discontinued in patients with progressive disease (PD). For responses other than PD, treatment was repeated for ≥1 cycle.
  
  
  RESULTS
  The objective early response rate was 60.0 %. Cumulative survival rates were 71.6 % at 6 months, 53.7 % at 12 months, 28.6 % at 18 months, and 14.3 % at 24 months. Median survival time was 14.6 months. All adverse reactions were controllable by temporary suspension of treatment. Serious complications and treatment-related deaths were not observed.
  
  
  CONCLUSIONS
  The combination therapy of PEG-IFNα-2b and 5-FU for advanced ICC seems not to be worse than the results of the previous studies. Furthermore, most adverse effects are transient and well tolerated. Based on the present findings, this combination therapy may be useful for patients with advanced ICC as one of the therapeutic option.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Iwate Medical University, Morioka, Iwate, Japan, kaz-k@yc4.so-net.ne.jp.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Kasai
authors.forename: Yohei
authors.initials: Y
authors.lastname: Kooka
authors.forename: Yuji
authors.initials: Y
authors.lastname: Suzuki
authors.forename: Akiko
authors.initials: A
authors.lastname: Suzuki
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Oikawa
authors.forename: Akira
authors.initials: A
authors.lastname: Ushio
authors.forename: Yukiho
authors.initials: Y
authors.lastname: Kasai
authors.forename: Kei
authors.initials: K
authors.lastname: Sawara
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Miyamoto
authors.forename: Kanta
authors.initials: K
authors.lastname: Oikawa
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Takikawa
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D000998:Antiviral Agents / Q000627:therapeutic use*; D001650:Bile Duct Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D001653:Bile Ducts, Intrahepatic / Q000473:pathology; D018281:Cholangiocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007261:Infusions, Intra-Arterial; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D010865:Pilot Projects; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011379:Prognosis; D011994:Recombinant Proteins / Q000627:therapeutic use; D015996:Survival Rate
chemical_list: D000964:Antimetabolites, Antineoplastic; D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b; D005472:Fluorouracil