Bevacizumab plus IFL improves survival in metastatic colorectal cancer
Bevacizumab is monoclonal antibody against vascular endothelial growth factor and has been approved by the FDA for the initial treatment of metastatic colorectal cancer in combination with Fluorouracil containing treatment regimens. This FDA approval is mainly based on the clinical trial by Hurwitz et al that was published in New England Journal of Medicine June 3, 2004 issue.
Here are the highlights from this study:
- Total patients 813, with no prior therapy for metastatic colorectal cancer
- Irinotecan Fluorouracil and Leucovorin (IFL) plus placebo (411 patients)
- Irinotecan Fluorouracil and Leucovorin (IFL) plus bevacizumab (402 patients)
- Dose of bevacizumab was 5mg/Kg every two weeks
- Primary end point of the study was improvement in overall survival
- The following are the results of the study bevacizumab arm Vs placebo arm
- Overall survival 20.3 months Vs 15.6 months
- Hazard ratio of death 0.66 (p<.001)
- Progression free survival 10.6 months Vs 6.2 months
- Response rate 44.8% Vs 34.8% (p<0.004)
- Duration of response 10.4 months Vs 7.1 months
- Incidence of hypertension 11% Vs 2.3% (more in bevacizumab arm)
Ref: NEJM June 3, 2004
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