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5. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer

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Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer
New England Journal of Medicine, 12/28/07

Miller K et al. - In a trial to compare the efficacy and safety of paclitaxel with paclitaxel plus bevacizumab as initial treatment for metastatic breast cancer, it was found that paclitaxel plus bevacizumab prolongs progression-free survival, but not overall survival, as compared with paclitaxel alone

Methods

Patients were assigned to receive 90 mg of paclitaxel per square meter of body-surface area on days 1, 8, and 15 every 4 weeks, either alone or with 10 mg of bevacizumab per kilogram of body weight on days 1 and 15
The primary end point was progression-free survival; overall survival was a secondary end point

Results

722 patients were enrolled
Paclitaxel plus bevacizumab significantly prolonged progression-free survival and increased the objective response rate
Overall survival rate, however, was similar in the two groups
Grade 3 or 4 hypertension, proteinuria, headache, and cerebrovascular ischemia were more frequent in patients receiving paclitaxel plus bevacizumab
Infection was more common in patients receiving paclitaxel plus bevacizumab, but febrile neutropenia was uncommon

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