Combined Analysis of Efficacy: The Addition of Bevacizumab to Fluorouracil/Leucovorin Improves Survival for Patients With Metastatic Colorectal Cancer

<jats:sec><jats:title>Purpose</jats:title><jats:p> Bevacizumab (Avastin; Genentech Inc, South San Francisco, CA), a recombinant, humanized anti–vascular endothelial growth factor monoclonal antibody that inhibits tumor angiogenesis, has demonstrated survival benefit in patients with previously untreated metastatic colorectal cancer when combined with irinotecan/fluourouracil (FU)/leucovorin (LV; IFL). Three randomized clinical studies have evaluated bevacizumab in combination with FU/LV alone. A combined analysis of raw data from these studies was performed to better assess the efficacy of bevacizumab with FU/LV. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> The analysis used primary efficacy data from three independent studies, including 241 patients in a combined control group receiving either FU/LV or IFL and 249 patients receiving FU/LV/bevacizumab (5 mg/kg once every 2 weeks). The efficacy data included response rate, progression-free survival, and overall survival. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> The median duration of survival was 17.9 months in the FU/LV/bevacizumab group, compared with 14.6 months in the combined control group, corresponding to a hazard ratio for death of 0.74 (P = .008). The median duration of progression-free survival was 8.8 months in the FU/LV/bevacizumab group, compared with 5.6 months in the combined control group, corresponding to a hazard ratio for disease progression of 0.63 (P ≤ .0001). The addition of bevacizumab also improved the response rate (34.1% v 24.5%; P = .019). </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> The addition of bevacizumab to FU/LV provides a statistically significant and clinically relevant benefit to patients with previously untreated metastatic colorectal cancer. </jats:p></jats:sec>