title: First-line treatment of pancreatic cancer patients with the combination of 5-fluorouracil/folinic acid plus gemcitabine: a multicenter phase II trial by the CONKO-study group.
abstract: OBJECTIVE
  This open-label, multi-center phase II study investigated the efficacy and safety of the combination of 5-fluorouracil (5-FU)/folinic acid (FA) plus gemcitabine (GFF) in patients with advanced pancreatic cancer. The study is based on our completed dose finding phase I trial.
  
  
  METHODS
  A total of 90 patients (pts) were recruited between 02/2000 and 04/2002 to receive 5-FU 750 mg/m(2) (24 h, i.v.), FA 500 mg/m(2) (2 h, i.v.) and gemcitabine 1,000 mg/m(2) (30 min, i.v.) on days 1, 8, 15, and 22. Treatment was repeated on day 43 until disease progression. The primary objective was the 1-year survival rate. The trial was conducted in compliance with the Declaration of Helsinki.
  
  
  RESULTS
  The 1-year survival rate was 25% [95% CI: 16-34], median overall survival was 6.8 months [95% CI: 5.13-8.45], 9 patients showed partial responses (PR) so that the overall response rate was 10.3%. Overall control rate (PR + stable disease for at least 6 months) was 56%. Median time to progression was 4.6 months [95% CI: 3.68-5.52]. In 402 GFF cycles, we observed adverse events grade 3 in up to 10% of patients and grade 4 below 5% of patients.
  
  
  CONCLUSIONS
  The GFF combination appears to be effective and well tolerated. This intravenous regimen represents an intensified therapy with low frequency of toxicities and seems to be convenient for patients who are unable to get oral anti-neoplastic medication. After these encouraging results, the German CONKO-002 trial investigated the GFF regimen versus single-agent gemcitabine.
authors.affiliation: Charité Centrum für Tumormedizin, Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany. uwe.pelzer@charite.de
authors.forename: Uwe
authors.initials: U
authors.lastname: Pelzer
authors.forename: Dirk
authors.initials: D
authors.lastname: Arnold
authors.forename: Peter
authors.initials: P
authors.lastname: Reitzig
authors.forename: Julia
authors.initials: J
authors.lastname: Herrenberger
authors.forename: Friedrich Wilhelm
authors.initials: FW
authors.lastname: Korsten
authors.forename: Manfred
authors.initials: M
authors.lastname: Kindler
authors.forename: Jens
authors.initials: J
authors.lastname: Stieler
authors.forename: Bernd
authors.initials: B
authors.lastname: Dörken
authors.forename: Hanno
authors.initials: H
authors.lastname: Riess
authors.forename: Helmut
authors.initials: H
authors.lastname: Oettle
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002955:Leucovorin; D005472:Fluorouracil; D000093542:Gemcitabine