Avastin may benefit some breast-cancer patients
The FDA last month rescinded approval for Avastin to treat advanced breast cancer because although preliminary studies show it led to longer periods of disease-free survival it did not increase overall survival. But a study presented Wednesday suggests their may be a role for Avastin after all.
The phase-3 study was conducted among 424 women a type of breast called HER-2 positive disease. A new analysis of the data, presented at the San Antonio Breast Cancer Symposium found that adding Avastin to a regimen of Herceptin and docetaxel resulted in a 28% reduced rate of disease progression or death. The study participants were women with locally recurrent or metastasized breast cancer.
“We have to search the subset of women who have the characteristics associated with benefit from addition” of Avastin, said the lead author of the study, Dr. Luca Gianni of the San Raffaele Cancer Center in Milan.
Biomarkers need to be developed to determine which patients will benefit, Gianni said.
Other studies presented at the meeting Wednesday also suggest a need to better identify patients who will benefit from targeted therapies -- medications that act on specific molecular characteristics.
“I have no doubt that Avastin is a very powerful drug for some patients,” said Dr. Gabriel Hortobagyi, chair of MD Anderson Cancer Center department of breast medical oncology. “The problem with Avastin is we don’t have a biomarker to help us identify the sub-group.”
Hortobagyi presented another study on Wednesday that found a drug called an aromatase inhibitor, which is already prescribed to patients with breast cancer, appears to be more effective when combined with the drug Afinitor, which is used to treat kidney cancer but is not yet approved for breast cancer. The trial was in women with advanced hormone receptor-positive breast cancer.
In yet another study, two standard medications for women with HER2-positive breast cancer – Herceptin and docetaxel – were more effecting when the investigational drug pertuzumab was added to the regimen. Officials at Genentech, which makes pertuzumab, said they will soon seek permission from the Food and Drug Administration to market the drug.
But doctors will need biomarker tests to show which patients can benefit from Afinitor or pertuzumab, Hortobagyi said. Drugs such as Avastin and Afinitor cost several thousand dollars a month.
The research released Wednesday also points to the value of combining targeted medications -- which act on specific molecular mechanisms -- to achieve better results, Hortobagyi said.
“These are very exciting data,” he said. “They are a paradigm-changing set of results. . .But it [will] be another several years for us to figure out if this will replace something we are currently doing or will extend survival.”
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