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| |  Everolimus Delays Disease Progression as Second-Line Therapy in Advanced Kidney Cancer: Presented at ASCO By Ed Susman CHICAGO -- June 1, 2008 -- The use of the biological agent everolimus appears to offer a longer time to progression for advanced renal cancer patients whose disease has progressed despite treatment with other agents, according to researchers presenting here at the American Society of Clinical Oncology (ASCO) 44th Annual Meeting. Patients taking everolimus (also known as RAD001) achieved a 4-month progression-free survival compared with placebo patients, whose time to progression was 1.9 months (P < .001), noted lead author Robert Motzer, MD, Memorial Sloan-Kettering Cancer Center, New York, New York, speaking here at a press briefing on May 31for this late-breaker abstract. "We saw a very large treatment effect with this drug," said Dr. Motzer, adding that the risk of a patient with renal cell cancer progressing was reduced 70% by being in the everolimus arm. "Everolimus should be the standard of care in this setting." Dr. Motzer and colleagues recruited 410 patients to their trial, all of whom were diagnosed with metastatic renal cell cancer with clear cell component. The patients had to have been taking the biological agents sunitinib or sorafenib, and had to have experienced disease progression within 6 months of taking those agents. After progressing with either sunitinib or sorafenib, those biological agents were discontinued. The patients entering the study were taking only everolimus 10 mg/d orally (n = 272) or placebo (n = 138), as well as best supportive care as determined by their clinicians, Dr. Motzer explained. "Most of the patients that I treated were on their second line of treatment, although many patients had been treated with both sunitinib and sorafenib before entering this trial," said Dr. Motzer. Even more pronounced than the difference in progression-free survival was that 26% of the patients on everolimus achieved 6 months of stable disease status compared with just 2% of the placebo patients, the researchers stated. At progression, treatment was unblinded and patients on placebo were offered open-label everolimus. As expected, more adverse events occurred in the patients receiving the active medication, although Dr. Motzer said the side-effect profile for patients in the study was "very acceptable." About 3% of patients experienced Grade 3 or Grade 4 stomatitis, asthaenia or fatigue, infections, or pneumonitis. Study follow-up is ongoing to assess the secondary endpoint of overall survival. Research for this study was provided by Genentech BioOncology; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; and Novartis Pharmaceuticals Corporation. Funding for this study was provided by Novartis Pharmaceuticals Corporation. [Presentation title: RAD001 Versus Placebo in Patients With Metastatic Renal Cell Carcinoma (RCC) After Progression on VEGFr-TKI Therapy: Results From a Randomized, Double-Blind, Multicenter Phase-III Study. Abstract LBA5026]
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