Phase II study of a triplet regimen in advanced colorectal cancer using methotrexate, oxaliplatin and 5-fluorouracil

A. Guglielmi, S. Barni, A. Zaniboni, N. Pella, O. Belvedere, G. D. Beretta, F. Grossi, L. Frontini, F. Puglisi, R. Labianca, A. Sobrero

Research output: Contribution to journalArticlepeer-review


Building upon the concept of schedule-specific biochemical modulation of 5-fluorouracil (FU), which alternates bolus and continuous infusion (CI) FU, we have incorporated oxaliplatin (I-OHP) following the bolus part of the regimen to explore the activity of this new combination. Patients with advanced, untreated, measurable colorectal cancer received sequential methotrexate (MTX) (days 1 and 15) → I-OHP + FU (days 2 and 16) (200, 85 and 600 mg m -2 respectively) followed by 3 weeks of CI FU (200 mg m-2 day-1) given from day 29 to 50, modulated by weekly leucovorin (LV) (20 mg m-2). After 1 week of rest, the second cycle was started. The treatment was continued until progression or patient's refusal. According to the intention-to-treat analysis on all 46 patients accrued, the response rate was 42% (95% CL = 28-55%), with three complete responses and 16 partial responses. The median overall survival was 15.9 months and the median progression-free survival 6.9 months. Toxicity was very mild, with the bolus part of the regimen more toxic than the infusional part (24 vs 7% of grade III-IV, respectively). This new combination of MTX → I-OHP-FU followed by FU CI is well tolerated, feasible and produces activity results similar to other more simple, but more toxic, regimens. Pros and cons of the different fluoropyrimidines-I-OHP combinations are discussed.

Original languageEnglish
Pages (from-to)1428-1433
Number of pages6
JournalBritish Journal of Cancer
Issue number8
Publication statusPublished - Oct 18 2004


  • 5-fluorouracil
  • Chemotherapy
  • Colorectal cancer
  • Methotrexate
  • Oxaliplatin

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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