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The investigative agent everolimus (RAD001) significantly prolongs progression-free survival among patients with advanced kidney cancer who have progressed following prior therapies. These results were recently published in an early on-line version of The Lancet.

The kidneys are each filled with tiny tubules that clean and filter the blood; this process removes waste and makes urine. Renal cell cancer (RCC) is a malignancy involving these tubules of the kidney. Metastatic RCC refers to cancer that has spread from the kidney to distant sites in the body.

Everolimus is an oral targeted therapy that works by inhibiting a protein known as the mammalian target of rapamycin (mTOR). The mTOR protein plays an important role in regulating cancer cell division and blood vessel growth. Everolimus is not yet approved by the United States Food and Drug Administration (FDA) but is continuing through clinical trials.

Researchers from the Memorial Sloan Kettering Cancer Center (MSKCC) and other institutions in Europe recently conducted a clinical trial to evaluate the effectiveness of everolimus among patients with advanced RCC. This trial included 400 patients whose cancer had progressed following prior therapy with Sutent® (sunitinib), Nexavar® (sorafenib) or both. Patients were divided into two groups: one group was treated with everolimus and the other group received a placebo (inactive substitute).

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• Median progression-free survival was 4 months for those treated with everolimus compared to only 1.9 months for those who received placebo.

• Inflammation of the mouth (stomatitis) was the most common side effect associated with everolimus.

The researchers concluded that everolimus improves progression-free survival compared with placebo among patients with advanced RCC whose disease has progressed following prior therapies. Patients with recurrent RCC may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial further evaluating everolius or other promising therapeutic approaches.

Reference: Motzer R, Escudier B, Oudard S, et al. Efficacy of Everolimus in Advanced Renal Cell Carcinoma: a Double-Blind, Randomised, Placebo-Controlled Phase III Trial. The Lancet. Early online publication. July 2008. DOI: 10.1016/S0140-6736(08)61039-9.

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