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Title: Everolimus Prolongs Survival in Patients With Advanced Renal Cell Carcinoma
URL: http://www.pslgroup.com/dg/221A32.htm
Doctor's Guide
May 19, 2008

NEW YORK -- May 19, 2008 -- New data from an international, multicentre, phase 3 clinical trial has found that the experimental targeted therapy everolimus (RAD001) significantly delays cancer progression in patients with metastatic renal cell carcinoma whose disease had worsened on other treatments. The study was led by Robert Motzer, MD, Attending Physician, Memorial Sloan-Kettering Cancer Center (MSKCC), New York, New York, who will present the findings on May 31 at the annual meeting of the American Society for Clinical Oncology.

"This study has given us a new and clearly useful tool for treating renal cell tumours, and everolimus is an important step forward in terms of disease management and quality of life for patients living with this disease," said Dr. Motzer.

Everolimus, a once-daily oral therapy, targets the mTOR protein, which acts as a central regulator of tumour cell division, cell metabolism, and angiogenesis. It is currently being evaluated for the treatment of several other cancers including lymphoma and neuroendocrine tumours.

More than 400 patients participated in this study, all of whom had disease that had progressed with currently available targeted therapies sunitinib and/or sorafenib. Patients were randomised to receive everolimus or placebo. After 6 months, 26% of patients in the everolimus group had disease that had not progressed, compared with only 2% of the placebo group. The average difference in progression-free survival was 4 months for everolimus, compared with 1.9 months for the placebo group.

In February 2008, an independent monitoring committee stopped the phase 3 trial after interim results were positive and allowed researchers to offer everolimus to the patients receiving placebo.

"For almost 20 years, we made no headway in the management of advanced kidney cancer," notes Dr. Motzer. "Recently, the identification of several new angiogenesis-targeted agents has provided us with new treatment options and an improved outlook for patients with advanced kidney cancer. Based on the results of this trial, everolimus could become another tool in our armamentarium; and, in the future, kidney cancer is likely to be managed as a chronic disease with these types of treatment advances."

Everolimus was well tolerated by patients, and the most common side effects were mouth ulcers, anaemia, skin rash, and weakness.


SOURCE: Memorial Sloan-Kettering Cancer Center

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