Multicenter phase II study of fractionated bimonthly oxaliplatin with leucovorin and 5-fluorouracil in patients with metastatic colorectal cancer, pre-treated with chemotherapy

  • Authors:
    • F. Recchia
    • S. Rea
    • A. Nuzzo
    • A. Lalli
    • L. Di Lullo
    • S. De Filippis
    • G. Saggio
    • A. Di Blasio
    • E. Massa
    • G. Mantovani
  • View Affiliations

  • Published online on: January 1, 2003     https://doi.org/10.3892/or.10.1.65
  • Pages: 65-69
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Abstract

In vitro and in vivo studies have shown that oxaliplatin (L-OHP), 5-fluorouracil (5-FU) and leucovorin (L) have a synergistic activity on metastatic colorectal cancer (MCC). In order to better exploit the synergism of action between the three drugs, L-OHP was administered over 2 days, together with 5-FU-L, in a cohort of patients with MCC that had been pre-treated with chemotherapy. Forty-six patients were entered into the trial. All had been pre-treated with chemotherapy for metastatic disease: 14 with the ‘de Gramont’ regimen alone, and 32 with the same regimen combined with irinotecan (CPT-11). The outpatient treatment consisted of L-OHP 50 mg/m2, followed immediately by the ‘de Gramont’ regimen. All drugs were administered on days 1 and 2, every 14 days. Median patient age was 65 years (range: 46-78), male/female ratio was 29/17. All 46 patients were evaluated for response and toxicity. We observed 1 complete response (2.2%) and 14 partial responses (30.4%), giving an overall response rate of 32.6% (95% CI: 19.5-48.06%); 22 patients had stable disease (47.8%) and 9 patients progressed (19.6%). After a median follow-up of 13 months, median time to progression was 6.4 months (range: 3.1-31.2+), while overall median survival was 12.2 months (range: 3.7-31.2+). Toxicity was manageable: grade 3 or 4 neutropenia was observed in 33% of patients, while only 6% of patients had grade 1-2 neurotoxicity. The fractionated bimonthly schedule of L-OHP plus 5-FU-L, showed activity, with an acceptable toxicity profile, both in patients with MCC pre-treated with the ‘de Gramont’ regimen alone, or with this regimen associated with CPT-11.

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January-February 2003
Volume 10 Issue 1

Print ISSN: 1021-335X
Online ISSN:1791-2431

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Spandidos Publications style
Recchia F, Rea S, Nuzzo A, Lalli A, Di Lullo L, De Filippis S, Saggio G, Di Blasio A, Massa E, Mantovani G, Mantovani G, et al: Multicenter phase II study of fractionated bimonthly oxaliplatin with leucovorin and 5-fluorouracil in patients with metastatic colorectal cancer, pre-treated with chemotherapy. Oncol Rep 10: 65-69, 2003.
APA
Recchia, F., Rea, S., Nuzzo, A., Lalli, A., Di Lullo, L., De Filippis, S. ... Mantovani, G. (2003). Multicenter phase II study of fractionated bimonthly oxaliplatin with leucovorin and 5-fluorouracil in patients with metastatic colorectal cancer, pre-treated with chemotherapy. Oncology Reports, 10, 65-69. https://doi.org/10.3892/or.10.1.65
MLA
Recchia, F., Rea, S., Nuzzo, A., Lalli, A., Di Lullo, L., De Filippis, S., Saggio, G., Di Blasio, A., Massa, E., Mantovani, G."Multicenter phase II study of fractionated bimonthly oxaliplatin with leucovorin and 5-fluorouracil in patients with metastatic colorectal cancer, pre-treated with chemotherapy". Oncology Reports 10.1 (2003): 65-69.
Chicago
Recchia, F., Rea, S., Nuzzo, A., Lalli, A., Di Lullo, L., De Filippis, S., Saggio, G., Di Blasio, A., Massa, E., Mantovani, G."Multicenter phase II study of fractionated bimonthly oxaliplatin with leucovorin and 5-fluorouracil in patients with metastatic colorectal cancer, pre-treated with chemotherapy". Oncology Reports 10, no. 1 (2003): 65-69. https://doi.org/10.3892/or.10.1.65