title: Docetaxel plus gemcitabine or docetaxel plus cisplatin in advanced pancreatic carcinoma: randomized phase II study 40984 of the European Organisation for Research and Treatment of Cancer Gastrointestinal Group.
abstract: OBJECTIVE
  To define the efficacy and toxicity of docetaxel plus gemcitabine or docetaxel plus cisplatin for advanced pancreatic carcinoma.
  
  
  METHODS
  Chemotherapy-naive patients with measurable disease and WHO performance status less than 2 were randomly assigned to receive 21-day cycles of gemcitabine 800 mg/m2 on days 1 and 8 plus docetaxel 85 mg/m2 on day 8 (arm A) or docetaxel 75 mg/m2 on day 1 plus cisplatin 75 mg/m2 on day 1 (arm B). Primary end points were tumor response and rate of febrile neutropenia grade.
  
  
  RESULTS
  Of 96 randomly assigned patients (49 patients in arm A and 47 patients in arm B), 70 patients were analyzed for response (36 in arm A and 34 in arm B) and 89 patients were analyzed for safety (45 in arm A and 44 in arm B). Confirmed responses were observed in 19.4% (95% CI, 8.2% to 36.0%) of patients in arm A and 23.5% (95% CI, 10.7% to 41.2%) in arm B. In arm A, the median progression-free survival (PFS) was 3.9 months (95% CI, 3.0 to 4.7 months), median survival was 7.4 months (95% CI, 5.6 to 11.0 months), and 1-year survival was 30%. In arm B, the median PFS was 2.8 months (95% CI, 2.6 to 4.6 months), median survival was 7.1 months (95% CI, 4.8 to 8.7 months), and 1-year survival was 16%. Febrile neutropenia occurred in 9% and 16% of patients in arms A and B, respectively.
  
  
  CONCLUSIONS
  Both regimens are well tolerated and show activity in advanced pancreatic carcinoma. The safety profile and survival analyses favor docetaxel plus gemcitabine for further evaluation.
authors.affiliation: University of Ulm, Ulm, Germany. m.lutz@caritasklinik.de
authors.forename: Manfred P
authors.initials: MP
authors.lastname: Lutz
authors.forename: Eric
authors.initials: E
authors.lastname: Van Cutsem
authors.forename: Theo
authors.initials: T
authors.lastname: Wagener
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Van Laethem
authors.forename: Udo
authors.initials: U
authors.lastname: Vanhoefer
authors.forename: Jacques A
authors.initials: JA
authors.lastname: Wils
authors.forename: Eric
authors.initials: E
authors.lastname: Gamelin
authors.forename: Claus H
authors.initials: CH
authors.lastname: Koehne
authors.forename: Jean P
authors.initials: JP
authors.lastname: Arnaud
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Mitry
authors.forename: Faress
authors.initials: F
authors.lastname: Husseini
authors.forename: Peter
authors.initials: P
authors.lastname: Reichardt
authors.forename: Mustafa
authors.initials: M
authors.lastname: El-Serafi
authors.forename: Pierre-Luc
authors.initials: PL
authors.lastname: Etienne
authors.forename: Thomas
authors.initials: T
authors.lastname: Lingenfelser
authors.forename: Michel
authors.initials: M
authors.lastname: Praet
authors.forename: Bruno
authors.initials: B
authors.lastname: Genicot
authors.forename: Muriel
authors.initials: M
authors.lastname: Debois
authors.forename: Bernard
authors.initials: B
authors.lastname: Nordlinger
authors.forename: Michel P
authors.initials: MP
authors.lastname: Ducreux
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D002945:Cisplatin; D000093542:Gemcitabine