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Future of bevacizumab for breast cancer may be in jeopardy

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The FDA is expected to determine this week whether bevacizumab (Avastin, Genentech) has a future as neoadjuvant chemotherapy for the treatment of HER2-negative breast cancer.

The committee meeting will occur in the wake of data presented at the breast cancer symposium in San Antonio last week. Results indicated that the pathologic complete response rate associated with bevacizumab failed to reach statistical significance according to study protocols.

The GeparQuinto study involved 1,889 HER2-negative, treatment-naive women with early or locally advanced primary breast cancer. The data are the first randomized phase-3 trial results of bevacizumab with chemotherapy outside the metastatic setting.

Patients were randomly assigned epirubicin (Ellence, Pharmacia & Upjohn) 90 mg/m² and cyclophosphamide (Cytoxan, Baxter) 600 mg/m² alone or with bevacizumab 15 mg/kg. If responses were observed after four cycles, patients were randomly assigned four cycles of docetaxel (Taxotere, Sanofi Aventis) 100 mg/m² alone or with bevacizumab, followed by surgery.

The initial regimen yielded a response rate of 15.0%; that rate increased to just 17.5% when bevacizumab was added. Similarly, statistically non-significant results were observed when other definitions of response rate were used.

After bevacizumab was linked to modest PFS rates in earlier trials, the FDA committee held a nearly unanimous vote in July to revoke the drug’s only indication for metastatic breast cancer use.

For more information:

• von Minckwitz G #S4-6. Presented at: The 33rd Annual San Antonio Breast Cancer Symposium; Dec 8-12, 2010. San Antonio.

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