Zosia Chustecka

December 13, 2010

December 13, 2010 (San Antonio, Texas) — Bevacizumab (Avastin) added to chemotherapy showed no benefit in early breast cancer in the first phase 3 study reported in this patient population.

So far, bevacizumab is approved for use in metastatic breast cancer, although this has become controversial, and a decision by the US Food and Drug Administration (FDA) on whether or not to rescind that approval is pending (and expected on December 17).

The negative results from the first phase 3 study to test the drug in early breast cancer (the GeparQuinto trial) were presented here at the 33rd Annual San Antonio Breast Cancer Symposium.

The study involved 1948 patients who were treated with epirubicin plus cyclophosphamide, followed by docetaxel, explained principal investigator Gunter von Minckwitz MD, PhD, managing director of the German Breast Group.

The addition of bevacizumab to standard chemotherapy did improve the pathologic complete response (17.5% vs 15% in the control group; not significant), and the breast conservation rates were similar in the 2 groups (66.6% vs 65.8%).

At the same time, the addition of bevacizumab increased the frequency of adverse events, including febrile neutropenia, nausea, mucositis, and poorer wound healing.

A subset analysis suggested that there was a benefit of bevacizumab in a subgroup of women with triple-negative breast cancer, Dr. von Minckwitz noted.

Negative Result

Discussing this study at a Hot Topics session after the presentation, Hyman Muss, MD, professor of medicine at the University of North Carolina in Chapel Hill, said: "I was surprised to see that it was negative."

He added that the results "were a little bit disappointing," because bevacizumab has shown benefit in metastatic breast cancer.

"This was a clear negative result," said Alan Coates MD, from the University of Sydney in Australia.

This was a reasonable question to ask, he told Medscape Medical News, adding that "it's important to ask these questions and to get clear-cut answers."

Dr. Coates, who is cochair of the scientific committee of the International Breast Cancer Study Group, explained that this study in early breast cancer was designed when there was a lot of enthusiasm for bevacizumab, sparked by the positive results in metastatic breast cancer from the E2100 trial. Those results showed a significant improvement in progression-free survival and led to the accelerated FDA approval for this indication. However, that approval is being reconsidered after 2 subsequent studies in metastatic breast cancer showed much less benefit, as previously reported in detail by Medscape Medical News.

There was a general enthusiasm for antiangiogenic agents and the idea that their mechanism of action would be useful across all tumor types, Dr. Coates said. But this has not been borne out by clinical data with either antibodies (such as bevacizumab) or small molecule compounds (such as sunitinib), he explained.

The GeparQuinto study received financial/drug support from Sanofi-Aventis and Roche.

33rd Annual San Antonio Breast Cancer Symposium (SABCS): Abstract S4-6. Presented December 10, 2010.

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