Bevacizumab plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal Cancer
- Study type
- Clinical trial
- Study name
- AVF2107g
- Phase
- Phase 3
- Design
- Randomised placebo-controlled trial
- Sample size
- 813 patients
- Source
- N Engl J Med · 2004
In plain words
In this study, patients with advanced bowel (colorectal) cancer who had not yet been treated received either chemotherapy with the drug bevacizumab or chemotherapy with a placebo. Adding bevacizumab helped patients live about 4.7 months longer on average (20.3 versus 15.6 months) and stay free of disease progression for longer. High blood pressure was more common in the bevacizumab group, but it was easy to control.
Key results
Treatment arms and regimens
402 patients; bolus IFL (irinotecan 125 mg/m², fluorouracil 500 mg/m² and leucovorin 20 mg/m² IV, once weekly for 4 weeks every 6 weeks) + bevacizumab 5 mg/kg IV every 2 weeks; bevacizumab was continued until disease progression, unacceptable toxicity or a maximum of 96 weeks.
411 patients; bolus IFL at the same doses (irinotecan 125, fluorouracil 500 and leucovorin 20 mg/m², weekly for 4 of every 6 weeks) + placebo. (A third arm of bevacizumab + fluorouracil/leucovorin was closed after 110 patients had been enrolled, as planned in the adaptive design.)
Source of the regimen details: Abstract of the paper and the FDA label for bevacizumab (AVASTIN; Clinical Studies section, AVF2107g)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with previously untreated metastatic colorectal cancer. Other eligibility criteria are not given in the abstract.
Endpoints
Primary endpoint: overall survival. Secondary endpoints: progression-free survival, response rate, duration of response, safety and quality of life.
Safety and side effects
Grade 3 hypertension was more common in the IFL plus bevacizumab group (11.0% versus 2.3%) but was easily managed.
Clinical significance and place in guidelines
This study showed that adding bevacizumab to fluorouracil-based chemotherapy significantly improves survival in patients with metastatic colorectal cancer. The current status of approvals and guideline recommendations should be checked in up-to-date sources.
Limitations
The abstract does not mention the limitations of the study. The IFL chemotherapy regimen used in this study is no longer a common regimen; up-to-date guidelines should be consulted to assess its relevance today.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.