title: Multicenter, phase II study of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer.
  
  
  METHODS
  Patients with a measurable lesion and no previous history of chemotherapy or radiotherapy were enrolled. Gemcitabine was administered intravenously at a dose of 1,000 mg/m(2) over 30 min on day 1 and 15, repeated every 4 weeks. S-1 was administered orally at a dose of 40 mg/m(2) b.i.d. on days 1-14. Tumor response was assessed every two cycles using Response Evaluation Criteria in Solid Tumors criteria.
  
  
  RESULTS
  As much as 35 patients were enrolled between December 2006 and July 2008; 14 patients (40%) with gallbladder cancer and 14 (40%) with intrahepatic cholangiocarcinoma were included and 7 patients (20%) had received previous surgical resection. The overall response rate was 34.3% and the overall disease control rate was 82.9%. The median overall survival time was 11.6 months (95% CI, 7.3-15.6 months), and the median time to progression was 5.9 months (95% CI, 4.0-7.7 months). The grade 3/4 toxicities were leucopenia (23%), neutropenia (34%), anemia (20%), thrombocytopenia (6%) and anorexia (3%).
  
  
  CONCLUSIONS
  Gemcitabine and S-1 combination chemotherapy has promising efficacy and good tolerability in patients with advanced biliary tract cancer.
authors.affiliation: Department of Gastroenterology, Faculty of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Sasaki
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.forename: Yousuke
authors.initials: Y
authors.lastname: Nakai
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Ito
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kogure
authors.forename: Osamu
authors.initials: O
authors.lastname: Togawa
authors.forename: Nobuo
authors.initials: N
authors.lastname: Toda
authors.forename: Ichiro
authors.initials: I
authors.lastname: Yasuda
authors.forename: Osamu
authors.initials: O
authors.lastname: Hasebe
authors.forename: Iruru
authors.initials: I
authors.lastname: Maetani
authors.forename: Naoki
authors.initials: N
authors.lastname: Sasahira
authors.forename: Kenji
authors.initials: K
authors.lastname: Hirano
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tsujino
authors.forename: Minoru
authors.initials: M
authors.lastname: Tada
authors.forename: Masao
authors.initials: M
authors.lastname: Omata
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000093542:Gemcitabine