SABCS 2011: Exemestane Plus Everolimus Increased Progression-Free Survival for Women With Metastatic Breast Cancer

The combination of everolimus (Afinitor) and the aromatase inhibitor exemestane (Aromasin) improved progression-free survival in women diagnosed with metastatic breast cancer, according to results of the Breast Cancer Trials of Oral Everolimus (BOLERO-2). Results of a preplanned interim analysis of phase III clinical trial were published yesterday in the New England Journal of Medicine, and updated results, discussed here, will be presented today at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium.

The trial enrolled 724 postmenopausal patients with hormone receptor-positive metastatic breast cancer and evidence of progressive disease while receiving anastrozole or letrozole. In other words, these patients developed resistance to these endocrine therapies. Researchers randomly assigned 485 patients to treatment with exemestane plus everolimus and 239 patients to treatment with exemestane plus placebo. Patients receiving everolimus had an extended progression-free survival, with a median progression-free interval of 7.4 months compared to 3.2 months for patients treated with exemestane plus placebo. The combination was also well tolerated. According to author Dr. Gabriel N. Hortobagyi, “These results highlight the progress being made in understanding the evolving mechanisms of resistance to standard therapies.” However, it will be important to see the overall survival analysis in the future to know if the addition of everolimus to the treatment protocol offers a real clinical benefit to women.

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