Addition of either irinotecan or methotrexate to bolus 5-fluorouracil and high-dose folinic acid every 2 weeks in advanced colorectal carcinoma: A randomised study by the Southern Italy Cooperative Oncology Group

P. Comella, E. Crucitta, F. De Vita, L. De Lucia, A. Farris, F. Del Gaizo, S. Palmeri, A. Iannelli, S. Mancarella, S. Tafuto, L. Maiorino, F. Buzzi, G. De Cataldis, R. Casaretti, A. Avallone, M. Montella, G. Comella, M. Orditura, G. Catalano, V. LorussoM. De Lena, M. Biglietto, G. Sanna, M. G. Sarobba, C. Belli, A. Russo, V. Pizzardi, V. Accurso, A. Musca, A. Gravina, G. Leopaldi, C. Brunetti, D. Muci, S. Leo, F. Avino, L. De Luca, E. Greco, C. Aiello

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: The purpose of this study was to compare the activity and toxicity of the combination of irinotecan (IRI) plus folinic acid (FA)-modulated 5-fluorouracil (5-FU) i.v. bolus with a regimen of double modulation of 5-FU with methotrexate (MTX) and FA in patients with advanced colorectal carcinoma. Patients and methods: Two-hundred and thirty-four patients were enrolled: 118 patients received IRI 200 mg/m2 (90-min i.v. infusion) on day 1, followed by levo-FA 250 mg/m2 (2-hi.v. infusion) and 5-FU 850 mg/m2 (i.v. bolus) on day 2 (IRIFAFU), and 116 patients received MTX 750 mg/m2 (2-h i.v. infusion) on day 1, followed by levo-FA 250 mg/m2 (2-h i.v. infusion) and FU 800 mg/m2 (i.v. bolus) on day 2 (MTXFAFU). Both cycles were repeated every 2 weeks until progression or to a maximum of 16 cycles. Response rate (RR) was the main end point of the study; responses were assessed every four cycles and confirmed after 2 additional months of treatment. Results: RR was significantly greater with IRIFAFU (36%) than with MTXFAFU (20%) (P

Original languageEnglish
Pages (from-to)866-873
Number of pages8
JournalAnnals of Oncology
Volume13
Issue number6
DOIs
Publication statusPublished - 2002

Keywords

  • Advanced colorectal carcinoma
  • Combination regimen
  • Irinotecan plus modulated 5-fluorouracil
  • Randomised trial

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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