Phase IV study of bevacizumab in combination with infusional fluorouracil, leucovorin and irinotecan (FOLFIRI) in First-line metastatic colorectal cancer

Alberto Sobrero, Stephen Ackland, Stephen Clarke, Ramón Perez-Carrión, Silvia Chiara, John Gapski, Paul Mainwaring, Bernd Langer, Scott Young

Research output: Contribution to journalArticle

Abstract

Background: Bevacizumab (Avastin®) significantly improves overall survival (OS) and progression-free survival (PFS) when combined with first-line irinotecan (IFL) plus bolus 5-fluorouracil (5-FU) and leucovorin (LV) in patients with metastatic colorectal cancer (CRC). This open-label, phase IV trial evaluated the efficacy and safety of first-line bevacizumab in combination with IFL and infusional 5-FU/LV (FOLFIRI). Methods: Two-hundred and nine treatment-naïve metastatic CRC patients were enrolled and received bevacizumab and FOLFIRI every 2 weeks. Treatment was continued until disease progression. The primary objective was PFS, with additional determinations of OS, response and toxicity. Results: Median PFS was 11.1 months and is comparable to that observed in published phase III and community-based trials using first-line bevacizumab plus FOLFIRI, and to phase III trials using bevacizumab in combination with bolus 5-FU/LV plus IFL. Median OS was 22.2 months. Overall response rate was 53.1% and the disease control rate 85.6%. Most adverse events were grade 1/2 and were manageable. The most common grade 3/4 adverse events (≥10%) were neutropenia, venous thromboembolic events, diarrhea, and fatigue. Conclusion: Bevacizumab combined with first-line FOLFIRI is an effective and well-tolerated therapy option for patients with metastatic CRC.

Original languageEnglish
Pages (from-to)113-119
Number of pages7
JournalOncology
Volume77
Issue number2
DOIs
Publication statusPublished - Aug 2008

Keywords

  • Antiangiogenic therapy
  • Bevacizumab
  • Colorectal cancer
  • FOLFIRI
  • Progression-free survival
  • Vascular endothelial growth factor

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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