title: Fluoropyrimidines plus cisplatin versus gemcitabine/gemcitabine plus cisplatin in locally advanced and metastatic biliary tract carcinoma - a retrospective study.
abstract: OBJECTIVE
  This is a retrospective study of patients with advanced biliary tract carcinoma (BTC), who were treated with different regimens of chemotherapy.
  
  
  METHODS
  We studied patients with advanced BTC registered at the Department of Oncology at the Fundeni Clinical Institute between 2004 and 2008. The following data were analyzed: rate of response, progression free survival (PFS) to first and second line of chemotherapy, overall survival (OS) and drug toxicity. Ninety-six patients were eligible having either advanced intra or extrahepatic cholangiocarcinoma, or gallbladder cancer with no prior chemotherapy.
  
  
  RESULTS
  Out of 96 patients, 57 (59.4%) received fluoropyrimidines (FP)+cisplatin and 39 (40.6%) gemcitabine (Gem)+/-cisplatin. The median PFS for FP+cisplatin was 5.9 months (95%CI 5-6.9) and for Gem+/-cisplatin 6.3 months (95%CI 5.4-7.1), p=0.661. Median OS for FP+cisplatin was 10.3 months (95%CI 7.5-13.1) and for Gem+/-cisplatin 9.1 months (95%CI 7.0-11.2), p=0.098. On disease progression, 46 patients received second line CT (Gem or FP+/-platinum compounds). Median OS for patients with FP based first line and Gem+/-cisplatin in second line was 19 months (95%CI 8.9-29) higher than for the reverse sequence: 13.2 months (95%CI 12-14.4), but not statistically significant (p=0.830). All patients were evaluated for toxicities. Most patients (75.5%) reported at least one adverse event.
  
  
  CONCLUSIONS
  Our results through direct comparison of FP+cisplatin with Gem+/-cisplatin as first line treatment did not show any statistical differences in terms of rate of response, PFS and OS. However, our study showed that FP+cisplatin as first line and Gem based second line therapy gave a better OS rate.
authors.affiliation: Department of Medical Oncology, Fundeni Clinical Institute Bucharest, Romania. adina.croitoru09@yahoo.com
authors.forename: Adina
authors.initials: A
authors.lastname: Croitoru
authors.forename: Iulia
authors.initials: I
authors.lastname: Gramaticu
authors.forename: Ioana
authors.initials: I
authors.lastname: Dinu
authors.forename: Liana
authors.initials: L
authors.lastname: Gheorghe
authors.forename: Sorin
authors.initials: S
authors.lastname: Alexandrescu
authors.forename: Florina
authors.initials: F
authors.lastname: Buica
authors.forename: Ioana
authors.initials: I
authors.lastname: Luca
authors.forename: Gabriel
authors.initials: G
authors.lastname: Becheanu
authors.forename: Vlad
authors.initials: V
authors.lastname: Herlea
authors.forename: Iulia
authors.initials: I
authors.lastname: Simionov
authors.forename: Doina
authors.initials: D
authors.lastname: Hrehoret
authors.forename: Ioana
authors.initials: I
authors.lastname: Lupescu
authors.forename: Irinel
authors.initials: I
authors.lastname: Popescu
authors.forename: Mircea
authors.initials: M
authors.lastname: Diculescu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001650:Bile Duct Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017734:Bile Ducts, Extrahepatic; D001653:Bile Ducts, Intrahepatic; D000069287:Capecitabine; D002277:Carcinoma / Q000188:drug therapy / Q000556:secondary; D018281:Cholangiocarcinoma / Q000188:drug therapy* / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D005706:Gallbladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine