title: Fixed-dose-rate gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas.
abstract: BACKGROUND
  Biliary tract cancers (BTC) have a poor prognosis, and there is no consensus on the best chemotherapy regimen. This study determined the response rate for fixed-dose-rate (FDR) gemcitabine combined with cisplatin.
  
  
  METHODS
  This multicentre phase II trial enrolled 50 patients with inoperable locally advanced or metastatic BTC. Treatment consisted of FDR gemcitabine 1,000 mg/m² (10 mg/m²/min) and cisplatin 20 mg/m² on days 1 and 8 of a 21-day cycle. The primary endpoint was response rate. Secondary endpoints included safety, response duration (RD), progression-free (PFS) and overall survival (OS), and cancer antigen 19-9 response.
  
  
  RESULTS
  Thirteen patients (26%, 95% CI 14.6-40.4) had a partial response, and 12 (24%) had stable disease. The median RD was 8.3 months (95% CI 6.91-9.99); median PFS 4 months (95% CI 2.5-6.77); and median OS 6.8 months (95% CI 5.0-8.7). Treatment was well tolerated. Grade 3 and grade 4 nausea, vomiting, and fatigue were uncommon. Thirty-eight per cent of patients discontinued treatment because of toxicity, patient or clinician preference.
  
  
  CONCLUSIONS
  This treatment combination had moderate activity with acceptable toxicity, supporting previous results that this combination has a role to play. The study does not suggest that FDR gemcitabine is superior to bolus infusion.
authors.affiliation: Department of Medical Oncology, Prince of Wales Hospital, Randwick, NSW, Australia. d.goldstein@unsw.edu.au
authors.forename: David
authors.initials: D
authors.lastname: Goldstein
authors.forename: M Corona
authors.initials: MC
authors.lastname: Gainford
authors.forename: Chris
authors.initials: C
authors.lastname: Brown
authors.forename: Niall
authors.initials: N
authors.lastname: Tebbutt
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Ackland
authors.forename: Guy
authors.initials: G
authors.lastname: van Hazel
authors.forename: Michael
authors.initials: M
authors.lastname: Jefford
authors.forename: Ehtesham
authors.initials: E
authors.lastname: Abdi
authors.forename: Sid
authors.initials: S
authors.lastname: Selva-Nayagam
authors.forename: Val
authors.initials: V
authors.lastname: Gebski
authors.forename: Danielle
authors.initials: D
authors.lastname: Miller
authors.forename: Jenny
authors.initials: J
authors.lastname: Shannon
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018395:CA-19-9 Antigen / Q000378:metabolism*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013534:Survival; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D018395:CA-19-9 Antigen; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine