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The addition of Avastin® (bevacizumab) to the chemotherapy agent Taxotere® (docetaxel) improves progression-free survival in patients with advanced breast cancer. These results were recently published in a press release by Genentech.

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.

One such targeted therapy, Avastin, blocks a protein known as vascular endothelial growth factor (VEGF), which stimulates the growth of new blood vessels. Avastin is already approved for the treatment of some colorectal and lung cancers. Avastin, in combination with the chemotherapy agent Taxol® (paclitaxel), is currently being reviewed by the FDA for the treatment of breast cancer.

To further evaluate the combination of Avastin and chemotherapy, researchers conducted the AVADO trial, a Phase III trial (phase prior to FDA review), to evaluate the combination of Avastin and Taxotere in advanced breast cancer. This trial included 736 patients who had not received prior therapy and were human epidermal receptor-2 (HER-2) negative. Women were treated with either Avastin plus Taxotere or placebo (inactive substitute) plus Avastin. Data from this trial, including the following results, will be presented at an upcoming medical conference.

  • Patients treated with Avastin had a longer time to cancer progression than patients who did not receive Avastin.
  • There were no side effects associated with Avastin that were not expected.

These results indicate that, cancer compared with chemotherapy alone, the addition of Avastin to chemotherapy improves progression-free survival among women with advanced HER2-negative breast. Decisions regarding approval of Avastin for breast cancer are eagerly awaited.

Reference: AVADO Study of Avastin Plus Docetaxel Chemotherapy Showed Improved Progression-Free Survival in Patients with Advanced Breast Cancer. Genentech. Available at: . Accessed February 2008.

Related News:Addition of Avastin® Doesn’t Improve Overall Survival in Metastatic Breast Cancer(1/3/2008)

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Addition of Avastin™ to Chemotherapy Improves Progression-Free Survival in Advanced Breast Cancer

Addition of Avastin™ to Chemotherapy Improves Progression-Free Survival in Advanced Breast Cancer

According to interim results from a recent phase III clinical trial, the addition of the targeted agent Avastin™(bevacizumab) to the chemotherapy agent paclitaxel (Taxol®) improves progression-free survival compared to paclitaxel alone as initial treatment in metastatic breast cancer.

Breast cancer is one of the most common cancers diagnosed in women. It is estimated that approximately 250,000 women are diagnosed annually in the United States and 40,000 deaths are attributed to breast cancer each year. Metastatic breast cancer refers to cancer that has spread from the breast to distant sites in the body, often invading vital organs. Survival for patients with metastatic breast cancer is poor, with the average survival time from diagnosis of this advanced stage of cancer being 18 to 30 months. Some patients, however, may achieve long-term survival. Treatment for metastatic breast cancer is aimed at improving the duration of survival and/or quality of life for patients, but often not with the intent to cure. Paclitaxel is a chemotherapy agent that is commonly used in the treatment of breast cancer.

An arena of cancer research that has been gaining a lot of attention involves the inhibition of angiogenesis. Cancer cells require food, oxygen and growth proteins in order to grow and spread. These essential nutrients are transported to the cancer cells by blood vessels. Angiogenesis is the process of creating new blood vessels necessary to transport food to the cancer cells. Two key proteins that are necessary for the process of angiogenesis are called matrix metalloproteinases (MMPs) and vascular endothelial growth factor (VEGF). VEGF causes endothelial cells (cells comprising the innermost layer of blood vessels) to replicate and migrate from existing blood vessels to the cancer. Endothelial cells secrete MMPs, which create an opening in existing tissues surrounding the cancer, allowing the endothelial cells to move near the cancer and form new blood vessels to feed the cancer.

Avastin™ (bevacizumab) is an agent that targets VEGF so that it cannot bind to its targeted cell and stimulate angiogenesis. Avastin™ is currently FDA-approved in combination with 5-fluorouracil (5-FU)-based chemotherapy regimens for the initial treatment of metastatic colorectal cancer. However, researchers have been evaluating Avastin™ in combination with different chemotherapy agents and various scheduling within treatment regimens to determine its possible effectiveness in an expanded role.

Researchers affiliated with the National Cancer Institute (NCI) and the Eastern Cooperative Oncology Group (ECOG) recently conducted a multi-institutional clinical trial to evaluate the effectiveness of Avastin™ in the treatment of breast cancer. This trial included 722 women with metastatic breast cancer who had not received prior therapy. Approximately half of the patients were treated with Avastin™ plus paclitaxel, and the other half were treated with paclitaxel only. The outcomes of the two groups were then directly compared. Results from an interim analysis has indicated that progression-free survival was significantly improved in the group of women treated with Avastin™/paclitaxel, compared to paclitaxel alone. More specific results will be released at the 2005 annual meeting of the American Society of Clinical Oncology in May, 2005. Avastin™ was very well tolerated, and the most common side effects associated more often with the group of patients treated with Avastin™ were high blood pressure, changes in the nervous system and protein in the urine.

The researchers concluded that the addition of Avastin™ to paclitaxel improves progression-free survival as initial treatment in advanced breast cancer. Specific results will be presented in the near future. Patients with metastatic breast cancer may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial further evaluating Avastin™ or other promising therapeutic strategies. Two sources of information regarding ongoing clinical trials include the National Cancer Institute ( and

Reference: Genentech. Interim Analysis Of Phase III Trial Shows Avastin Plus Chemotherapy Improved Progression-Free Survival In Patients With First-Line Metastatic Breast Cancer. Available at: . Accessed April 2005.

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