Oxaliplatin added to 5-fluorouracil-based therapy (5-FU ± FA) in the treatment of 5-FU-pretreated patients with advanced colorectal carcinoma (ACRC): Results from the european compassionate-use program

S. Brienza, M. A. Bensmaïne, P. Soulié, C. Louvet, E. Gamelin, E. François, M. Ducreux, M. Marty, T. André, F. De Braud, H. Bleiberg, V. Ségal, M. Itzhaki, E. Cvitkovic

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: To provide evidence for the therapeutic efficacy of oxaliplatin (Eloxatin®) when given as a 2-6-hour i.v. infusion, alone or in combination with 5-fluorouracil/folinic acid (5-FU ± FA) in patients with advanced colorectal carcinoma (ACRC) who have failed 5-FU-based therapy. To confirm the safety of the drug and its combination in an extended-access context. Patients and methods: Prescribing physicians were supplied oxaliplatin on a nominative compassionate-use basis, after obtaining informed consent. Europe- wide, 206 ACRC patients in 44 centers received 1168 cycles of chemotherapy with oxaliplatin (80-100 mg/m2 q 2 weeks or 100-135 mg/m2 q 3 weeks) delivered as a short (2-6 hours) i.v. infusion, 177 of them (1026 cycles) receiving oxaliplatin + 5-FU ± FA. Results: Oxaliplatin added to the 5-FU ± FA regimens of 111 verified 5-FU-refractory patients (imaging and/or clinical proof of progression under prior 5-FU-based regimen), elicited objective responses in 25 of 98 evaluable patients, (ORR: 25.5%, 95% confidence interval (95% CI: 17-35). The median time to progression was 4.1 months (95% CI: 3.3-5.0) and the median overall survival was 9.6 months (95% CI: 8.210.9). Differences in the toxicity profile of the oxaliplatin + 5-FU ± FA combination appear related to administration modality, dose and schedule of the 5-FU-based regimen. Conclusions: The addition of oxaliplatin (2-6-hour i.v. infusion) to 5-FU ± FA regimens is active in ACRC patients with clinical resistance to fluoropyrimidines. The therapeutic index of oxaliplatin + 5-FU ± FA combinations administered as salvage therapy compares favorably with those reported in recent phase II-III trials involving other new agents or combinations active in 5-FU-refractory ACRC patients.

Original languageEnglish
Pages (from-to)1311-1316
Number of pages6
JournalAnnals of Oncology
Volume10
Issue number11
DOIs
Publication statusPublished - 1999

Keywords

  • 5-fluorouracil
  • Efficacy
  • Oxaliplatin
  • Platinum compounds
  • Salvage chemotherapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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