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

108 Citations (Scopus)

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

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irinotecan
Leucovorin
Fluorouracil
Colorectal Neoplasms
Disease-Free Survival
Survival
Bevacizumab
Neutropenia
Fatigue
Disease Progression

Keywords

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

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase IV study of bevacizumab in combination with infusional fluorouracil, leucovorin and irinotecan (FOLFIRI) in First-line metastatic colorectal cancer. / Sobrero, Alberto; Ackland, Stephen; Clarke, Stephen; Perez-Carrión, Ramón; Chiara, Silvia; Gapski, John; Mainwaring, Paul; Langer, Bernd; Young, Scott.

In: Oncology, Vol. 77, No. 2, 08.2008, p. 113-119.

Research output: Contribution to journalArticle

Sobrero, Alberto ; Ackland, Stephen ; Clarke, Stephen ; Perez-Carrión, Ramón ; Chiara, Silvia ; Gapski, John ; Mainwaring, Paul ; Langer, Bernd ; Young, Scott. / Phase IV study of bevacizumab in combination with infusional fluorouracil, leucovorin and irinotecan (FOLFIRI) in First-line metastatic colorectal cancer. In: Oncology. 2008 ; Vol. 77, No. 2. pp. 113-119.
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abstract = "Background: Bevacizumab (Avastin{\circledR}) 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-na{\"i}ve 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.",
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AU - Sobrero, Alberto

AU - Ackland, Stephen

AU - Clarke, Stephen

AU - Perez-Carrión, Ramón

AU - Chiara, Silvia

AU - Gapski, John

AU - Mainwaring, Paul

AU - Langer, Bernd

AU - Young, Scott

PY - 2008/8

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N2 - 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.

AB - 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.

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KW - Colorectal cancer

KW - FOLFIRI

KW - Progression-free survival

KW - Vascular endothelial growth factor

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