title: Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group.
abstract: OBJECTIVE
  This phase III trial compared the efficacy and safety of gemcitabine (Gem) plus capecitabine (GemCap) versus single-agent Gem in advanced/metastatic pancreatic cancer.
  
  
  METHODS
  Patients were randomly assigned to receive GemCap (oral capecitabine 650 mg/m2 twice daily on days 1 to 14 plus Gem 1,000 mg/m2 by 30-minute infusion on days 1 and 8 every 3 weeks) or Gem (1,000 mg/m2 by 30-minute infusion weekly for 7 weeks, followed by a 1-week break, and then weekly for 3 weeks every 4 weeks). Patients were stratified according to center, Karnofsky performance score (KPS), presence of pain, and disease extent.
  
  
  RESULTS
  A total of 319 patients were enrolled between June 2001 and June 2004. Median overall survival (OS) time, the primary end point, was 8.4 and 7.2 months in the GemCap and Gem arms, respectively (P = .234). Post hoc analysis in patients with good KPS (score of 90 to 100) showed a significant prolongation of median OS time in the GemCap arm compared with the Gem arm (10.1 v 7.4 months, respectively; P = .014). The overall frequency of grade 3 or 4 adverse events was similar in each arm. Neutropenia was the most frequent grade 3 or 4 adverse event in both arms.
  
  
  CONCLUSIONS
  GemCap failed to improve OS at a statistically significant level compared with standard Gem treatment. The safety of GemCap and Gem was similar. In the subgroup of patients with good performance status, median OS was improved significantly. GemCap is a practical regimen that may be considered as an alternative to single-agent Gem for the treatment of advanced/metastatic pancreatic cancer patients with a good performance status.
authors.affiliation: Division of Oncology, Department of Internal Medicine, University Hospital of Basel, Basel, Switzerland. herrmannr@uhbs.ch
authors.forename: Richard
authors.initials: R
authors.lastname: Herrmann
authors.forename: György
authors.initials: G
authors.lastname: Bodoky
authors.forename: Thomas
authors.initials: T
authors.lastname: Ruhstaller
authors.forename: Bengt
authors.initials: B
authors.lastname: Glimelius
authors.forename: Emilio
authors.initials: E
authors.lastname: Bajetta
authors.forename: Johannes
authors.initials: J
authors.lastname: Schüller
authors.forename: Piercarlo
authors.initials: P
authors.lastname: Saletti
authors.forename: Jean
authors.initials: J
authors.lastname: Bauer
authors.forename: Arie
authors.initials: A
authors.lastname: Figer
authors.forename: Bernhard
authors.initials: B
authors.lastname: Pestalozzi
authors.forename: Claus-Henning
authors.initials: CH
authors.lastname: Köhne
authors.forename: Walter
authors.initials: W
authors.lastname: Mingrone
authors.forename: Salomon M
authors.initials: SM
authors.lastname: Stemmer
authors.forename: Karin
authors.initials: K
authors.lastname: Tàmas
authors.forename: Gabriela V
authors.initials: GV
authors.lastname: Kornek
authors.forename: Dieter
authors.initials: D
authors.lastname: Koeberle
authors.forename: Susanne
authors.initials: S
authors.lastname: Cina
authors.forename: Jürg
authors.initials: J
authors.lastname: Bernhard
authors.forename: Daniel
authors.initials: D
authors.lastname: Dietrich
authors.forename: Werner
authors.initials: W
authors.lastname: Scheithauer
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine