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Avastin Added to Chemo Before Surgery Offers No Benefit

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Treatment given to weaken and destroy breast cancer BEFORE surgery is called neoadjuvant treatment. Neoadjuvant treatment isn't used routinely to treat early-stage breast cancer, but may be used if the cancer is large or aggressive. Neoadjuvant treatment is more likely to be used before surgery to treat breast cancer that has spread outside the breast to other tissue in the breast area (locally advanced breast cancer). One or more chemotherapy medicines are usually used for neoadjuvant treatment.

A study found that adding the targeted therapy Avastin (chemical name: bevacizumab) to a neoadjuvant chemotherapy combination didn't benefit women diagnosed with early-stage or locally advanced breast cancer. The results were presented at the 2010 San Antonio Breast Cancer Symposium (SABCS).

Avastin is a targeted therapy medicine that is given intravenously. Avastin works by blocking the growth of new blood vessels that cancer cells need to grow and function. A protein called vascular endothelial growth factor (VEGF) makes new blood vessels grow in cancer cells. Avastin blocks the VEGF protein.

Avastin is currently approved by the U.S. Food and Drug Administration (FDA) to be used in combination with Taxol (chemical name: paclitaxel) to treat metastatic, HER2-negative breast cancer that hasn't been treated with chemotherapy. Metastatic breast cancer is cancer that has spread outside the breast to another part of the body. Avastin also is used to treat advanced-stage lung, colon, and kidney cancer. Avastin is given intravenously.

On Dec. 16, 2010, the FDA announced that it is recommending removing the breast cancer indication for Avastin because recent research suggests the benefits of Avastin to treat breast cancer don't outweigh the risks of treatment. The recommendation is being appealed by the company that makes Avastin.

In this study, 1,889 women newly diagnosed with early-stage or locally advanced HER2-negative breast cancer were treated with one of two neoadjuvant regimens:

  • half the women got the chemotherapy medicines Ellence (chemical name: epirubicin) and Cytoxan (chemical name: cyclophosphamide); if there was some response to the treatment, they then got Taxotere (chemical name: docetaxel)
  • the other half got Ellence and Cytoxan; if there was some response to treatment, they then got Taxotere and Avastin

After neoadjuvant treatment, the women had surgery to remove the cancer. The researchers looked at the tissue removed to see how the cancer responded to the neoadjuvant treatment. "Complete pathologic response" is the term researchers use if there are no active cancer cells in the tissue.

Women who got Avastin as part of the neoadjuvant treatment were no more likely to have a pathologic complete response than women who didn't get Avastin:

  • 15% of the women who got neoadjuvant treatment without Avastin had a pathologic complete response
  • 17.5% of the women who got neoadjuvant treatment that included Avastin had a pathologic complete response

This difference wasn't statistically significant, which means it could have been due to chance and not because of the difference in treatment.

The women who got neoadjuvant Avastin and chemotherapy were more likely to have serious side effects compared to women who got only neoadjuvant chemotherapy. The most common serious side effects were severe mouth sores (called mucositis) and low white blood cell counts (called neutropenia, which can lead to fever and increase the risk of serious infection).

Despite these results, some experts still think Avastin may have benefits for some women diagnosed with early-stage or locally advanced breast cancer, either before or after surgery. More research is being done to study this.

If you've recently been diagnosed with early-stage or locally advanced breast cancer and haven't had surgery yet, you might want to ask your doctor if neoadjuvant treatment has benefits for you. Neoadjuvant treatment won't be recommended for most women diagnosed with early-stage breast cancer, but may be considered if the cancer is large, aggressive, or the recurrence risk (risk of the cancer coming back) is much higher than average. Neoadjuvant treatment often will be recommended for women diagnosed with locally advanced breast cancer.

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