title: A phase II trial of S-1 and cisplatin in patients with metastatic or relapsed biliary tract cancer.
abstract: BACKGROUND
  Optimal chemotherapy for advanced biliary tract cancer (BTC) is yet to be defined. We carried out this study to evaluate the efficacy and toxicity of combination chemotherapy with S-1 and cisplatin in metastatic or relapsed BTC.
  
  
  METHODS
  Patients with pathologically proven BTC were eligible. The chemotherapy regimen consisted of S-1 (40 mg/m(2) p.o. b.i.d. from D1-14) and cisplatin (60 mg/m(2) on D1), repeated every 3 weeks.
  
  
  RESULTS
  Fifty-one BTC patients (metastatic:relapsed = 37:14, Gall-bladder:intrahepatic bile ducts:extrahepatic bile ducts = 16:25:10) were enrolled from January 2005 to December 2006. Median age was 57 years (range, 31-71) and most patients had a good performance status. The overall response rate was 30% [95% confidence interval (CI), 17.3-42.7] and complete response was observed in two patients (4%), partial response in 13 (26%), stable disease in 21 (42%), and progressive disease in 9 (18%). With a median follow-up of 12.4 months, the median time to progression was 4.8 months (95% CI, 3.3-6.3) and median overall survival was 8.7 months (95% CI, 6.0-11.4). Major toxic effects were grade 3/4 neutropenia (8.9% of all cycles) and febrile neutropenia was observed in six cycles (2.7% of all cycles).
  
  
  CONCLUSIONS
  Combination chemotherapy with S-1 and cisplatin was a moderately effective outpatient-based regimen in BTC patients. Toxic effects were moderate but manageable.
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Y J
authors.initials: YJ
authors.lastname: Kim
authors.forename: S-A
authors.initials: SA
authors.lastname: Im
authors.forename: H G
authors.initials: HG
authors.lastname: Kim
authors.forename: S Y
authors.initials: SY
authors.lastname: Oh
authors.forename: K W
authors.initials: KW
authors.lastname: Lee
authors.forename: I S
authors.initials: IS
authors.lastname: Choi
authors.forename: D Y
authors.initials: DY
authors.lastname: Oh
authors.forename: S H
authors.initials: SH
authors.lastname: Lee
authors.forename: J H
authors.initials: JH
authors.lastname: Kim
authors.forename: D W
authors.initials: DW
authors.lastname: Kim
authors.forename: T Y
authors.initials: TY
authors.lastname: Kim
authors.forename: S W
authors.initials: SW
authors.lastname: Kim
authors.forename: D S
authors.initials: DS
authors.lastname: Heo
authors.forename: Y B
authors.initials: YB
authors.lastname: Yoon
authors.forename: Y J
authors.initials: YJ
authors.lastname: Bang
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018450:Disease Progression; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects; D016879:Salvage Therapy; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D013921:Thrombocytopenia / Q000139:chemically induced
chemical_list: D004338:Drug Combinations; D011725:Pyridines; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin; C104201:gimeracil