Everolimus (Afinitor) with exemestane provides significantly longer disease-free time for women with hormone sensitive breast cancer, even where there was resistance to Arimidex and Femara. Article posted September 27, 2011

September 27, 2011: Source: Medscape

Women with hormone-sensitive breast cancer, but resistance to Arimidex and / or Femara now seem still to have another option. Everolimus given alongside fulvestrand - Exemestane appears particularly well to save. From a randomized phase III study shows that the disease-free time was prolonged from 2.8 months to 6.9 months compared with exemestane in women only where the treatment would be successful. The response for the combination treatment went from 0.4% to 9.6%. This does not seem much but if 1 in 10 women who appeared still uitbehandeld an effective approach to get that is still good. Moreover, even though everolimus in advanced kidney cancer , where other means failed, and in Waldenstrom proven to be an excellent resource. Here is an excerpt from an article by Medscape on the recent study presented at the EMCC yesterday.

The combination of everolimus (Afinitor, Novartis) plus exemestane HAS produced "the strongest data ever seen in estrogen receptor-positive breast cancer 699528693

Source: Medscape

The results from this large phase 3 trial show that "Everolimus is the first agent to Enhance Hormone therapy in refractory ER-positive breast cancer patients," and They represent a "paradigm shift in the management or thesis patient," he told delegates.

The study was conducted BOLERO-2 in 724 postmenopausal women with ER-positive but HER2-negative advanced breast cancer who had bone Previously Treated with and had become refractory to the nonsteroidal aromatase inhibitor letrozole and anastrozole. Previous therapies included tamoxifen (in 48% patients), fulvestrant (16%) and chemotherapy (in 68%).

"When responding to Stop patiënten Hormonal therapy, the benefits from any secondary therapy are limited," Dr.. Baselga Explained.

All of the women in the study received exemestane, a steroidal aromatase inhibitor which is a Slightly different profile than with letrozole or anastrozole. In Addition, women were randomized in a 2:1 ratio to receive everolimus (10 mg / day orally).

A preplanned interim analysis found significantly improved everolimus That progression-free survival, the primary end point of the study. Median progression-free survival, reassessed by local investigators, was longer with exemestane than with everolimus plus exemestane alone (6.9 vs. 2.8 months, hazard ratio [HR], 0.43, P ≤ .0001). These figures Slightly changed after central assessment (10.6 vs. 4.1 months, HR 0.36, P <.0001).

These results were highly significant, Dr.. Baselga emphasized. "This is a very uncommon result in meta-static disease," he said at a press briefing. "Very Seldom do you see Such an effect."

In Addition, there was a significantly Greater response rates (9.5% vs 0.4%) and clinical benefit (33.4% vs. 18.0%) in the combination group. Dr. That thesis Baselga noted data are immature and likely to Improve.

The most common adverse effects reported in the exemestane and combination groups alone were stomatitis (8% and 1%, respectively), anemia (5% and 1%), dyspnea (4% and 1%), hypoglycemia (4% and < 1%), fatigue (3% and 1%), and pneumonitis (3% and 0%).

"The safety profile was consistent with previous experience everolimus," Dr. Baselga Explained.

In a statement from the manufacturer, Novartis Oncology President Hervé Hoppenot said: "Everolimus is the first drug to show significant efficacy When combined with hormone therapy in ER-positive and HER2-negative breast cancer, where there continues to be a critical unmet need. "

"The magnitude of benefit seen in patiënten thesis, despite resistance to previous Their Hormonal therapies, everolimus Represents That shows a potential important new treatment approach," he added.

This trial was funded BOLERO-2 by Novartis. Dr. Baselga reports acting as a consultant for many pharmaceutical companies, include Novartis, Roche, Merck SA, and Bayer.

2011 European Multidisciplinary Cancer Congress (EMCC): Abstract 9LBA. Presented September 26, 2011.