The results of a clinical trial, published today in the New England Journal of Medicine, showed that the addition of Avastin (Bevacizumab) to Taxol alone doubles progression free survival. In other words, the amount of time that passes before there is evidence of recurrence is much longer.
In an open-label,  randomized, phase 3 clinical trial, Dr. Miller and coworkers compared the efficacy and safety of paclitaxel with that of paclitaxel plus bevacizumab (Avastin), a monoclonal antibody against vascular endothelial growth factor, as initial treatment for metastatic breast Cancer. The following is a technical summary of the study and conclusions.
Methods Patients received 90 mg of paclitaxel per square meter of body-surface area on days 1, 8, and 15 every 4 weeks, either alone or with with addition of 10 mg of bevacizumab per kilogram of body weight on days 1 and 15. The primary study question was to assess progression-free survival. Evaluation of overall survival was a secondary end point.
Results The study spanned December 2001 through May 2004, during which time 722 patients were enrolled. Paclitaxel plus bevacizumab significantly prolonged progression-free survival as compared with paclitaxel alone (median, 11.8 vs. 5.9 months; hazard ratio for progression, 0.60; P<0.001) and increased the objective response rate (36.9% vs. 21.2%, P<0.001). However the overall survival rate, was similar between the two groups (median, 26.7 vs. 25.2 months; hazard ratio, 0.88; P=0.16). Reported side effects were as follows: grade 3 or 4 hypertension (14.8% vs. 0.0%, P<0.001), proteinuria (3.6% vs. 0.0%, P<0.001), headache (2.2% vs. 0.0%, P=0.008), and cerebrovascular ischemia (1.9% vs. 0.0%, P=0.02). Which means that in every case they were more frequent in patients receiving paclitaxel plus bevacizumab. Infection was more common in patients receiving paclitaxel plus bevacizumab (9.3% vs. 2.9%, P<0.001), but febrile neutropenia was uncommon (<1% overall).
Study Conclusions: Initial treatment of metastatic breast cancer with paclitaxel plus bevacizumab prolongs progression-free survival, but not overall survival, as compared with paclitaxel alone. So, for the moderate increase in side effects, the length of time before recurrence is significantly longer. In the long run, however, patients did not live any longer with the addition with Avastin.
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