Bevacizumba Combined With Chemotherapy Improves Progression-Free Survival for Patients With Advanced Breast Cancer

Preliminary results from a large, randomized clinical trial for patients with previously untreated recurrent or metastatic breast cancer, cancer that has spread from the breast to other parts of the body, show that those patients who received bevacizumab (Avastin TM) in combination with standard chemotherapy had a longer time period before their cancer progressed than patients who received the same chemotherapy without bevacizumab.

The clinical trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG). Genentech, Inc., South San Francisco, Calif., which manufactures bevacizumab, provided bevacizumab for the trial under the Cooperative Research and Development Agreement (CRADA) with NCI for the clinical development of bevacizumab.

The Data Monitoring Committee overseeing the trial (known as E2100)* recommended that the results of a recent interim analysis be made public because the study had met its primary endpoint of increasing progression-free survival (the amount of time patients lived without the cancer getting worse).

Preliminary results suggest that patients in the study who received bevacizumab in combination with standard chemotherapy consisting of single-agent paclitaxel had a delay in worsening of their cancer by four months, on average, compared to patients treated with paclitaxel chemotherapy alone. This difference is statistically significant.

"This study is the first to find a benefit of anti-angiogenic therapy in patients with breast cancer and represents a major advance in the treatment of patients with metastatic disease," said Study Chair Kathy D. Miller, M.D., of the Indiana University Medical Center in Indianapolis, Ind. Anti-angiogenic drugs, also called angiogenesis inhibitors, are substances that may prevent angiogenesis, or the formation of blood vessels. In anticancer therapy, an angiogenesis inhibitor prevents the growth of blood vessels from surrounding tissue to a solid tumor.

"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.