“Recent clinical trials have shown that anti-angiogenic drugs have a favorable impact on colon and lung cancers,?said NCI Director Andrew C. von Eschenbach, M.D. “This study demonstrates that when patients with recurrent or metastatic breast cancer received bevacizumab in addition to their chemotherapy, the period of time that they lived with their cancer under control was increased. This is an important step in our journey to ultimately eliminate the suffering and death due to cancer.?/p>
A total of 722 women with recurrent or metastatic breast cancer who had not previously received systemic chemotherapy for their recurrent or metastatic disease were enrolled in this study between December 2001 and May 2004. Patients were randomized to one of the two treatment arms. One patient group received standard treatment consisting of single-agent paclitaxel. The second group received the same regimen of paclitaxel with the addition of bevacizumab.
Patients whose tumors overexpressed HER-2 were not included in the study unless they had previously received trastuzumab (Herceptin? or were unable to receive trastuzumab. Also excluded were patients who had received preventive chemotherapy treatment with paclitaxel within the previous 12 months, as well as patients with a prior history of blood clots or who were on blood thinners. Serious bleeding and blood clots were rare in this study. Patients receiving the combination of paclitaxel and bevacizumab had slightly more neuropathy, or problem in peripheral nerve function (any part of the nervous system except the brain and spinal cord); abnormally high blood pressure; and proteinuria, a condition in which urine contains an abnormal amount of protein, than patients receiving paclitaxel alone. Other side effects were similar between the two treatment groups.
Bevacizumab, a humanized monoclonal antibody*