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Study Shows Novartis Drug Afinitor® Plus Hormonal Therapy Delays Disease Progression in Advanced Metastatic Breast Cancer Patients
Date:12/9/2010

efined as complete response, partial response and stable disease (CR+PR+SD) at six months in the everolimus plus tamoxifen arm. For the intent-to-treat analysis, a gain in clinical benefit of at least 20 percent was needed to warrant further study of the combination regimen, which was met in this trial(1).

For patients receiving everolimus plus tamoxifen, time to disease progression, a secondary endpoint, was almost twice as long as it was for patients receiving tamoxifen alone (8.6 months in patients treated with the combination versus 4.5 months in patients treated with tamoxifen alone). Everolimus in combination with tamoxifen provided a statistically significant reduction in the risk of disease progression by 47% (hazard ratio=0.53 [95% CI, 0.35 to 0.81]; log-rank test: p=0.0026, exploratory analysis)(1).

Side effects were generally manageable in both arms of the study. Everolimus had to be decreased for 15 patients (28%). Treatment was stopped due to toxicities in three patients in the everolimus plus tamoxifen arm and in four patients in the tamoxifen-only arm. Grade 3-4 adverse events (>10%) were stomatitis (11% in the everolimus plus tamoxifen arm and 0% in the tamoxifen-only arm), pain (9% in the everolimus plus tamoxifen arm and 19% in the tamoxifen-only arm) and fatigue (6% in the everolimus plus tamoxifen arm and 11% in the tamoxifen-only arm)(1).

Novartis Pharmaceuticals Corporation provided drug and financial support for this study.

About Breast CancerBreast cancer is the most prevalent cancer in women worldwide and is increasing in developing countries where the majority of cases are diagnosed in late stages(9). Data has shown that approximately 30% of women with breast cancer will eventually develop metastatic or advanced disease(2). In 2008, breast cancer caused approximately 460,000 deaths worldwide(10).

Breast cancer can originate in lobes, milk-producing ducts and other tissue within the breast. In thes
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