Second-line chemotherapy with a hybrid-alternating regimen of bolus 5FU modulated by methotrexate and infusional 5FU modulated by folinic acid in patients with metastatic colorectal cancer pretreated with 5FU: A phase 2 study

C. Carlomagno, R. Lauria, M. De Laurentiis, G. Arpino, E. Massarelli, C. Ferrara, A. Milano, A. Vernaglia Lombardi, R. Costanzo, G. Catalano, A. R. Bianco, Sabino De Placido

Research output: Contribution to journalArticlepeer-review

Abstract

Background and Aim: In vitro, methotrexate (MTX) is the best modulator for bolus 5-fluorouracil (5FU), whereas folinic acid (FA) is the best for continuous infusion. We evaluated the effect of 5FU modulated by both MTX (bolus administration) and FA (continuous infusion) as second-line treatment of patients with metastatic colorectal cancer. Patients and Methods: Entry criteria were: at least one 5FU-based chemotherapy regimen as first-line treatment for metastatic disease, or progression within twelve months after 5FU-containing adjuvant therapy. Treatment schedule: MTX 200 mg/m2 i.v. days 1 and 15; 5FU 600 mg/m2 i.v. bolus, days 2 and 16; 5FU 200 mg/m2 i.v. continuous infusion for 21 days, starting on day 29; FA 20 mg/m2 i.v. bolus weekly during the three weeks of 5FU infusion. Cycles were repeated every 56 days. The primary end-point was tumour control rate, including partial responses and stabilizations. Results: 34/35 patients enrolled were evaluable for response. Five (14.7%) had a partial response, 13 (38.2%) disease stabilization, and 16 (47.1%) progressed; tumour control rate was 52.9%. Median TTP was 5.8 months (95% CI 4.03-7.83); 29 patients had died. Median OAS was 15.9 months (95% CI 8.8-21.9). Toxicity was mild. Conclusions: The regimen constituted by 5FU modulated by MTX (bolus administration) and FA (continuous infusion) is active as second-line treatment of metastatic colorectal cancer. Copyright

Original languageEnglish
Pages (from-to)219-225
Number of pages7
JournalOncology
Volume63
Issue number3
DOIs
Publication statusPublished - 2002

Keywords

  • 5-Fluorouracil
  • Folinic acid
  • Metastatic colorectal cancer
  • Methotrexate
  • Phase 2 study
  • Second-line chemotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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