Everolimus Added To Hormonal Therapy Postpones Disease Prog

[Janette]

Everolimus Added To Hormonal Therapy Postpones Disease Progression In Advanced Breast Cancer
14 Dec 2010

Women with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer who have previously received an aromatase inhibitor have slower disease progression when everolimus is added to tamoxifen compared to women who receive tamoxifen alone, according to the results of a phase 2 trial released at the 33rd Annual San Antonio Breast Cancer Symposium.

Everolimus is an investigational mTOR inhibitor.

Thomas Bachelot, MD, with the Centre Leon Berard in Lyon, and colleagues, randomized 111 women who were previously treated with an aromatase inhibitor in the adjuvant and/or metastatic setting to receive everolimus plus tamoxifen (10 mg/day plus 20 mg/day, respectively) or tamoxifen alone (20 mg/day).

There are limited treatment options for hormone receptor-positive metastatic breast cancer patients with disease resistant to or progressing on standard therapy, said Dr. Bachelot, who presented the data on behalf of the Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens du sein.

The study found that 61.1% of advanced breast cancer patients on everolimus plus tamoxifen had no tumor progression at six months compared with. 42.1% of women receiving tamoxifen alone. Also, patients on everolimus plus tamoxifen had a median time to disease progression of 8.6 months versus 4.5 months for women on tamoxifen alone.

Side effects were generally manageable in both study arms. At the most recent analysis, 25 of 57 patients in the tamoxifen arm had died versus nine of 54 patients in the everolimus plus tamoxifen arm.

"The near doubling of time to disease progression seen in the everolimus plus tamoxifen treatment arm reinforces the potential benefit of inhibiting mTOR to help overcome endocrine therapy resistance," Dr. Bachelot, said in a news release.

He added that based on the results, additional studies will test the combination of everolimus with hormonal therapies as a second-line treatment for patients with HR+/HER2- metastatic breast cancer.

Written by Jill Stein
Jill Stein is a Paris-based freelance medical writer.
Copyright: Medical News Today