title: Gemcitabine, oxaliplatin and 5-FU in advanced bile duct and gallbladder carcinoma: two parallel, multicentre phase-II trials.
abstract: BACKGROUND
  Gemcitabine, oxaliplatin and 5-fluorouracil (5-FU) are active in biliary tract cancer and have a potentially synergistic mode of action and non-overlapping toxicity. The objective of these trials was to determine response, survival and toxicity separately in patients with bile duct cancer (BDC) and gallbladder cancer (GBC) treated with gemcitabine/oxaliplatin/5-FU chemotherapy.
  
  
  METHODS
  Eligible patients with histologically proven, advanced or metastatic BDC (n=37) or GBC (n=35) were treated with gemcitabine (900 mg m(-2) over 30 min), oxaliplatin (65 mg m(-2)) and 5-FU (1500 mg m(-2) over 24 h) on days 1 and 8 of a 21-day cycle. Tumour response was the primary outcome measure.
  
  
  RESULTS
  Response rates were 19% (95% CI: 6-32%) and 23% (95% CI: 9-37%) for BDC and GBC, respectively. Median survivals were 10.0 months (95% CI: 8.6-12.4) and 9.9 months (95% CI: 7.5-12.2) for BDC and GBC, respectively, and 1- and 2-year survival rates were 40 and 23% in BDC and 34 and 6% in GBC (intention-to-treat analysis). Major grade III and IV adverse events were neutropenia, thrombocytopenia, elevated bilirubin and anorexia.
  
  
  CONCLUSIONS
  Triple-drug chemotherapy achieves comparable results for response and survival to previously reported regimens, but with more toxicity.
authors.affiliation: First Department of Medicine, University Hospital, Halle 06097 (Saale), Germany. Dorothea.wagner@chuv.ch
authors.forename: A D
authors.initials: AD
authors.lastname: Wagner
authors.forename: P
authors.initials: P
authors.lastname: Buechner-Steudel
authors.forename: M
authors.initials: M
authors.lastname: Moehler
authors.forename: H
authors.initials: H
authors.lastname: Schmalenberg
authors.forename: R
authors.initials: R
authors.lastname: Behrens
authors.forename: J
authors.initials: J
authors.lastname: Fahlke
authors.forename: A
authors.initials: A
authors.lastname: Wein
authors.forename: S
authors.initials: S
authors.lastname: Behl
authors.forename: O
authors.initials: O
authors.lastname: Kuss
authors.forename: G
authors.initials: G
authors.lastname: Kleber
authors.forename: W E
authors.initials: WE
authors.lastname: Fleig
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001650:Bile Duct Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005706:Gallbladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D005472:Fluorouracil; D000093542:Gemcitabine