Combination therapy improves progression-free survival in advanced breast cancer patients - BOLERO-2 Trial
October 5, 2011
The combination of two available cancer drugs - everolimus (Afinitor) and exemestane - improved progression-free survival in the BOLERO-2 phase III clinical trial. The results, which were presented at the European Multidisciplinary Cancer Congress, showed that women with ER-positive metastatic breast cancer who received the combination therapy lived for a median of 11 months without the disease progressing, compared with about 4 months for those who received exemestane alone. The trial was stopped early due to the positive results.
Everolimus is approved for treating forms of kidney cancer and pancreatic cancer, and works by inhibiting a protein called mTOR, which is involved in a growth-promoting cell signaling pathway. The aromatase inhibitor, exemestane, is used to treat metastatic breast cancer and may be effective when other aromatase inhibitors no longer work. After previous studies suggested a benefit in adding everolimus to other aromatase inhibitors and tamoxifen, the BOLERO-2 investigators looked at the combination of the two drugs in 724 patients from 24 countries. Many of the patients in the trial had already received mulitple therapies - all of the participants had received the aromatase inhibitors letrozole or anastrozole, nearly half had received tamoxifen, and two-thirds had received chemotherapy. The side effects of the combination therapy were "generally manageable."
The study does not provide information on overall survival, but he trial's sponsor, Novartis, plans to seek regulatory approval for everolimus for this new indication.
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