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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n\u003Cp id=\u0022p-1\u0022\u003ELate-breaking results from a phase 3, randomized, double-blind, multicenter study provide convincing evidence that RAD001 is a safe and effective treatment for patients with metastatic renal cell carcinoma and validate mTOR inhibition as a cancer treatment.\u003C\/p\u003E\n\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EGastrointestinal Cancers Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ELate-breaking results from a phase 3, randomized, double-blind, multicenter study provide convincing evidence that RAD001 (everolimus) is a safe and effective treatment for patients with metastatic renal cell carcinoma (mRCC) and validate mTOR inhibition as a cancer treatment. Robert J. Motzer, MD, Memorial Sloan-Kettering Cancer Center, New York, NY, presented data from the study (\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00410124\u0026amp;atom=%2Fspmdc%2F8%2F4%2F11.atom\u0022\u003ENCT00410124\u003C\/a\u003E), which compared RAD001 plus best supportive care (BSC) with BSC plus placebo in patients with mRCC. The trial was terminated after interim results demonstrated significantly better progression-free survival (PFS) for patients who received everolimus compared with those who received placebo.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAccording to Dr. Motzer, everolimus represents a new approach to cancer treatment by inhibiting the mTOR protein, a principal regulator of tumor cell division and blood cell vessel growth in cancer cells. \u201cThis is the first phase 3 trial that establishes clinical benefits and provides safety information for this new agent,\u201d he said.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe study randomly assigned 410 patients with metastatic clear cell carcinoma, whose disease had progressed while receiving vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFr-TKI) therapy (sunitinib, sorafenib, or both), to receive everolimus plus BSC or placebo plus BSC. Patients were randomly assigned, in a 2:1 ratio, to receive either 10 mg of orally administered everolimus or the same daily dose of a placebo. Treatment was repeated in 28-day cycles, allowing for assessments of response and safety and was continued unless there was disease progression or intolerance of the treatment. Patients who showed signs of progression were unblinded and, if they were in the placebo arm, were given the opportunity to receive everolimus. When the study was terminated in October 2007, all patients were unblinded, and those who were in the placebo arm were offered open-label everolimus.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAn analysis of data that followed early termination of the study showed a median PFS of 4.0 months for patients who received everolimus compared with 1.9 months for those in the placebo group (p\u0026lt;0.001; 95% CI; 0.22, 0.40). Twenty-six percent of patients in the everolimus group have experienced PFS of 6 months compared with 2% of patients in the placebo group. Secondary endpoints of safety and patient-reported outcomes were deemed acceptable. Median overall survival (OS) in the everolimus group is confounded by the built-in crossover and has not been reached. OS in the placebo group is 8.8 months. Additional data will be released when further analyses and follow-up are completed.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EDr. Motzer concluded that this trial establishes clinical benefit for everolimus following progression on tyrosine kinase inhibitor therapy with sunitinib or sorafenib. \u201cEverolimus is the first and only agent that has an established clinical benefit for the treatment of patients with mRCC in this clinical setting and should become the standard of care,\u201d he said.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2008 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/8\/4\/11.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzmfke\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}