To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Everolimus Effective in Renal Cell Carcinoma Progressed on Prior Treatments URL: http://www.pslgroup.com/dg/2262E6.htm Doctor's Guide July 22, 2008
NEW YORK -- July 22, 2008 -- Treatment with everolimus prolongs progression-free survival (PFS) compared with placebo in patients with metastatic renal cell carcinoma who have experienced treatment failure on other regimens, according to a study published early online and in an upcoming edition of The Lancet. The recent advent of sunitinib and sorafenib has seen improved PFS and overall survival in patients with renal cell carcinoma, but for the relatively new group of patients who have failed on these new treatments, there is a high unmet need for new therapies. Robert Motzer, MD, Memorial Sloan-Kettering Cancer Center, New York, New York, and colleagues conducted a randomised, controlled, phase 3 trial to test the efficacy of everolimus in these patients. Patients with metastatic renal cell carcinoma whose disease had progressed on sunitinib, sorafenib, or both were randomly assigned in a 2:1 ratio to receive everolimus 10 mg QD (n = 272) or placebo (n = 138), in conjunction with best supportive care. The primary endpoint was PFS, and the study was designed to end after 290 progression events. The researchers found that results of the second interim analysis showed a significant difference in efficacy favouring the everolimus arm, and the trial was thus stopped after 191 progression events as it was not ethical to continue without providing everolimus to all patients. Progression events were observed in 101 of 272 (37%) in the everolimus group and 90 of 138 (65%) in the placebo group. Analysis showed that patients in the everolimus group were less than one-third as likely to experience disease progression as those in the placebo group. Median PFS was more than twice as long in the everolimus group compared with placebo (4.0 vs 1.9 months). Adverse events were more common in the everolimus group compared with placebo and included stomatitis (40% vs 8%), rash (25% vs 4%), and fatigue (20% vs 16%). Most adverse events were mostly mild or moderate in severity. Pneumonitis (any grade) was detected in 22 patients in the everolimus group, of whom 8 had pneumonitis of grade 3 severity. "On the basis of the results of this trial, we believe that everolimus should now be considered as the standard of care in patients with metastatic renal cell carcinoma whose disease has progressed after treatment with VEGF [vascular endothelial growth factor]-targeted therapies," the authors wrote. In an accompanying comment, Jennifer J. Knox, MD, Princess Margaret Hospital, University of Toronto, Toronto, Ontario, said, "I would encourage international regulatory boards to accept these data as evidence of clinical benefit of everolimus in metastatic renal cell carcinoma that has progressed on prior targeted therapies." SOURCE: The Lancet --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.