Gemcitabine with or without continuous infusion 5-FU in advanced pancreatic cancer: A randomised phase II trial of the Italian oncology group for clinical research (GOIRC)

F. Di Costanzo, P. Carlini, L. Doni, B. Massidda, R. Mattioli, A. Iop, E. Barletta, L. Moscetti, F. Recchia, P. Tralongo, S. Gasperoni

Research output: Contribution to journalArticlepeer-review

Abstract

This study was performed to determine the activity of adding continuous infusion (CI) of 5-fluorouracil (5-FU) to gemcitabine (GEM) vs GEM alone in advanced pancreatic cancer (APC). In all, 94 chemo-naïve patients with APC were randomised to receive GEM alone (arm A: 1000 mg m-2 per week for 7 weeks followed by a 2 week rest period, then weekly for 3 consecutive weeks out of every 4 weeks) or in combination with Cl 5-FU (arm B: CI 5-FU 200 mg m-2 day-1 for 6 weeks followed by a 2 week rest period, then for 3 weeks every 4 weeks). Overall response rate (RR) was the primary end point and criteria for decision were planned according to the Simon's optimal two-stage design. The overall RR was 8% (arm A) and 11% (arm B) (95% confidence interval: 0.5-16% and 2-22%), respectively, and stable disease was 29 and 28%. The median duration of RR was 34 weeks (range 25-101 weeks) for GEM and 26 weeks (range 16-46 weeks) for the combination. The median progression-free survival (PFS) was 14 weeks (range 2-65 weeks) and 18 weeks (range 4-51 weeks), respectively. The median overall survival (OS) was 31 weeks (range 1-101 weeks) and 30 weeks (1-101 weeks). Toxicity was mild in both arms. This study does not show promising activity in terms of RR, PFS and OS for the double combination arm in APC.

Original languageEnglish
Pages (from-to)185-189
Number of pages5
JournalBritish Journal of Cancer
Volume93
Issue number2
DOIs
Publication statusPublished - Jul 25 2005

Keywords

  • 5-FU
  • Advanced pancreatic cancer
  • Gemcitabine

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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