To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Sorafenib Effective and Safe Against Kidney Cancer Regardless of Baseline Cardiovascular Status: Presented at ESMO URL: http://www.pslgroup.com/dg/22C1EE.htm Doctor's Guide September 13, 2008
By Jill Stein STOCKHOLM, Sweden -- September 13, 2008 -- Sorafenib treatment is effective and safe in patients with advanced kidney cancer, regardless of whether they have clinical cardiovascular diseases, researchers announced here at the 33rd European Society for Medical Oncology Congress (ESMO). Tim Eisen, MD, Cambridge Research Institute, Cambridge, United Kingdom, and colleagues evaluated whether the efficacy and safety of sorafenib were compromised in kidney cancer patients by the presence of baseline clinical cardiovascular diseases and found that baseline patient characteristics for those with and without clinical cardiovascular diseases were comparable with those of the overall population. Subjects in the phase 3, European Advanced Renal Cell Carcinoma Sorafenib (EU-ARCCS) trial included 1,159 patients with advanced renal-cell carcinoma, 490 of whom had baseline clinical cardiovascular diseases (defined as coronary heart disease, stroke, hypertension, or congestive heart failure). Subjects were randomised to receive sorafenib 400 mg twice daily until disease progression or intolerable toxicity. "Patients with baseline clinical cardiovascular diseases may be at increased risk of cardiovascular adverse events from therapies that target angiogenic pathways, because of pleiotropic effects on the vasculature and cardiac tissues," Dr. Eisen and his colleagues noted in their poster, presented here September 13. "However, patients with clinical cardiovascular diseases are frequently excluded from clinical trials of tyrosine kinase inhibitors," the researchers added, "and therefore limited data are available for this relevant population." The safety population was defined as all patients who received at least 1 dose of the study medication. At the time of this analysis, 978 patients had available safety data. Sorafenib was found to be safe and well tolerated in patients with advanced renal-cell carcinoma, irrespective of baseline clinical cardiovascular diseases, and the incidence of most cardiac adverse events was similar in patients with and without clinical cardiovascular diseases. Hypertension occurred in 2.1% of patients without clinical cardiovascular diseases and 7.7% of patients with clinical cardiovascular diseases. Cardiac ischaemia/infarction occurred in 0.8% and 1.1% of the 2 groups, respectively, arrhythmia in 0.2 % and 0.9%, hypotension in 0% and 0.2%, and left ventricular systolic dysfunction in 0.2% of each group. The investigators said that, while there was no increase in grade 3 or greater cardiac adverse events following sorafenib treatment in patients with baseline clinical cardiovascular diseases compared to patients without clinical cardiovascular diseases, patients may have been receiving medication to control clinical cardiovascular diseases since baseline. Funding for this study was provided by Bayer AG and Onyx Pharmaceuticals, Inc. [Presentation title: Large Open-Label, Non-Comparative Phase III Study of Sorafenib in European Pts With Advanced RCC (EU-ARCCS) - Subgroup Analysis of Pts With and Without Baseline Clinical Cardiovascular Diseases (CDD). Abstract 602P] --------------------------------------------------------------------------------------------- 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.