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 language | English |
|---|---|
| Pages (from-to) | 113-119 |
| Number of pages | 7 |
| Journal | Oncology |
| Volume | 77 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - Aug 2008 |
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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 journal › Article
}
TY - JOUR
T1 - Phase IV study of bevacizumab in combination with infusional fluorouracil, leucovorin and irinotecan (FOLFIRI) in First-line metastatic colorectal cancer
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
Y1 - 2008/8
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.
KW - Antiangiogenic therapy
KW - Bevacizumab
KW - Colorectal cancer
KW - FOLFIRI
KW - Progression-free survival
KW - Vascular endothelial growth factor
UR - http://www.scopus.com/inward/record.url?scp=67650996205&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=67650996205&partnerID=8YFLogxK
U2 - 10.1159/000229787
DO - 10.1159/000229787
M3 - Article
VL - 77
SP - 113
EP - 119
JO - Oncology
JF - Oncology
SN - 0030-2414
IS - 2
ER -