Oxaliplatin plus high-dose folinic acid and 5-fluorouracil i.v. bolus (OXAFAFU) versus irinotecan plus high-dose folinic acid and 5-fluorouracil i.v. bolus (IRIFAFU) in patients with metastatic colorectal carcinoma: A Southern Italy Cooperative Oncology Group phase III trial

Pasquale Comella, B. Massidda, G. Filippelli, S. Palmeri, D. Natale, A. Farris, F. De Vita, F. Buzzi, S. Tafuto, L. Maiorino, S. Mancarella, S. Leo, V. Lorusso, L. De Lucia, M. Roselli

Research output: Contribution to journalArticle

Abstract

Purpose: The primary end point of this phase III trial was to compare the response rate (RR) of oxaliplatin (OXA) plus levo-folinic acid (l-FA) and 5-fluorouracil (5-FU) bolus with that of irinotecan (IRI) plus l-FA and 5-FU bolus in advanced colorectal carcinoma. Patients and methods: Patients with measurable metastatic colorectal carcinoma were randomly allocated to receive: IRI 200 mg/m2 on day 1, l-FA 250 mg/m2 intravenously plus 5-FU 850 mg/m2 on day 2 (IRIFAFU); or OXA 100 mg/m2 on day 1, l-FA 250 mg/m2 plus 5-FU 1050 mg/m2 on day 2 [OXAFAFU high dose (hd)]. Cycles were given every 2 weeks. After a planned interim analysis, OXA was reduced to 85 mg/m2 and 5-FU to 850 mg/m2 [OXAFAFU low dose (ld)]. Results: Two hundred and seventy-four patients (IRIFAFU, 135; OXAFAFUhd, 71; OXAFAFUld, 68) were treated. Forty-two confirmed responses were achieved with IRIFAFU, 29 with OXAFAFUhd and 32 with OXAFAFUld. The response rate with OXAFAFU [44%; 95% confidence interval (CI) 35% to 52%] was significantly higher (P = 0.029) than that of IRIFAFU (31%; 95% CI 23% to 40%). Occurrence of grade ≥3 neutropenia with OXAFAFUld was similar to that for IRIFAFU (29% versus 31%), while severe diarrhoea was significantly lower (12% versus 24%). Median failure-free survival (7 versus 5.8 months; P = 0.046) and overall survival of patients (18.9 versus 15.6 months; P = 0.032) were significantly prolonged with OXAFAFU. Conclusions: OXAFAFU was more active and less toxic than IRIFAFU, and it should be preferred in the first-line treatment of advanced colorectal cancer patients.

Original languageEnglish
Pages (from-to)878-886
Number of pages9
JournalAnnals of Oncology
Volume16
Issue number6
DOIs
Publication statusPublished - Jun 2005

Keywords

  • 5-fluorouracil
  • Irinotecan
  • Metastatic colorectal carcinoma
  • Oxaliplatin
  • Randomized trial

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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