Addition of Avastin® Doesn't Improve Overall Survival in Metastatic Breast Cancer

Posted on January 3rd, 2008 by

Addition of Avastin® Doesn't Improve Overall Survival in Metastatic Breast Cancer

According to the results of a study published in the New England Journal of Medicine, treatment of metastatic breast cancer with a combination of Avastin® (bevacizumab) and paclitaxel (Taxol®) delays the time to cancer progression, but does not improve overall survival, compared with paclitaxel alone.

Metastatic breast cancer refers to cancer that has spread to distant sites in the body. Chemotherapy is a cornerstone of therapy for metastatic breast cancer; however, novel therapeutic approaches are now providing more targeted methods of treatment.

Avastin is a targeted therapy that blocks a protein known as vascular endothelial growth factor (VEGF). VEGF stimulates the growth of new blood vessels. Avastin is already approved for the treatment of some colorectal and lung cancers.

To evaluate the combination of Avastin and the chemotherapy drug paclitaxel in the initial treatment of metastatic breast cancer, researchers conducted a Phase III clinical trial. The trial enrolled 722 patients. A majority of the study participants had HER2-negative breast cancer. Half the patients were treated with Avastin and paclitaxel, and half were treated with paclitaxel alone.

  • The combination of Avastin and paclitaxel significantly improved progression-free survival. Median survival without cancer progression was 11.8 months among women treated with Avastin and paclitaxel and 5.9 months among women treated with paclitaxel alone.
  • Overall survival, however, was similar in the two groups. Median overall survival was 26.7 months among women treated with Avastin and paclitaxel and 25.2 months among women treated with paclitaxel alone.
  • Serious (grade 3 or 4) adverse effects of treatment that were more common among women treated with Avastin and paclitaxel than among women treated with paclitaxel alone included infection, fatigue, hypertension, proteinuria, headache, and cerebrovascular ischemia.

This study suggests that the addition of Avastin to paclitaxel improves progression-free survival but not overall survival among women with metastatic breast cancer.

Based on the results of this study, an FDA advisory committee recommended that Avastin not be approved for the initial treatment of metastatic breast cancer. The FDA is not obligated to follow advisory committee recommendations, but often does. The FDA is expected to makes its decision in February 2008.

Reference: Miller K, Wang M, Gralow J et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. New England Journal of Medicine. 2007;357:2666-76.

Related News: FDA Advisory Committee Does Not Recommend Approval for Avastin® for Breast Cancer (12/7/2007)

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Tags: Metastatic Breast Cancer, News

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