▴ Bevacizumab, a recombinant humanized monoclonal antibody directed against vascular endothelial growth factor, inhibits tumor angiogenesis and delays disease progression.
▴ Intravenous (IV) bevacizumab 5 mg/kg every 2 weeks, in combination with bolus irinotecan, fluorouracil and leucovorin (IFL), was administered as first-line therapy to patients with metastatic colorectal cancer in a large (n = 923), randomized, placebocontrolled, phase III trial.
▴ In this study, IFL plus bevacizumab significantly improved overall survival, progression-free survival, duration of response, and overall response rate compared with IFL plus placebo (p < 0.004 for each parameter).
▴ In combination with fluorouracil/leucovorin, IV bevacizumab 5 mg/kg every 2 weeks led to a significant increase in the median time to progression and response rate compared with fluorouracil/ leucovorin alone, in a randomized, phase II study (n = 104) of first-line therapy in a similar patient population (p < 0.029).
▴ Based on the available data, IV bevacizumab 5 mg/kg was generally well tolerated in patients with metastatic colorectal cancer. Hypertension was significantly more frequent in patients receiving bevacizumab in the phase III trial (p < 0.01). Bevacizumab was associated with a small increase in the incidence of gastrointestinal perforation and wound healing complications compared with comparators.