345 SHORT-TERM AND OFF-LABEL USE OF ORAL TARGETED THERAPY FOR PATIENTS WITH RENAL CELL CARCINOMA

Abstract

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Practice Patterns, Cost Effectiveness I1 Apr 2010345 SHORT-TERM AND OFF-LABEL USE OF ORAL TARGETED THERAPY FOR PATIENTS WITH RENAL CELL CARCINOMA Christopher Filson, Rodney Dunn, and David Miller Christopher FilsonChristopher Filson More articles by this author , Rodney DunnRodney Dunn More articles by this author , and David MillerDavid Miller More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.411AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES For a variety of reasons, including their easy administration and a lack of efficacious alternative therapies, sorafenib and sunitinib may be susceptible to both short-term and “off-label” administration among patients with renal cell carcinoma (RCC). Given this concern, we evaluated patterns of treatment with these oral targeted therapies (TT) among a large and diverse sample of patients with RCC. METHODS Using the MarketScan® Commercial Claims and Encounters Database (2003-2007), we identified a cohort of privately-insured individuals in the United States with a diagnosis of RCC. Among this sample, we used pharmacy claims to characterize prescribing patterns for sorafenib and sunitinib, the most common oral TTs. We specifically assessed the proportion of patients treated with oral TT for fewer than 60 days (i.e., short-term therapy). We also evaluated the prevalence of off-label use of TT, defined as sequential (e.g., sunitinib then sorafenib) and/or combination TT administration. Finally, we used chi-square testing to evaluate for an association between short-term and/or off-label regimens and the initial agent prescribed. RESULTS Among 102,742 patients with RCC, 456 (0.44%) underwent treatment with sorafenib and/or sunitinib from 2003 through 2007. Overall, 33% of these patients received short-term TT regimens (i.e., < 60 days); the prevalence of short-term therapy did not differ between oral agents (p =0.92, Figure). Among the 107 (24%) patients who received off-label TT, 86 (80%) and 21 (20%) received sequential and combination therapy, respectively. Compared to those receiving first-line sunitinib, patients treated initially with sorafenib were more likely to receive both sequential (26.9% vs. 13.3%, p<0.01) and combination treatment (8.1% vs 2.2%, p<0.01) (Figure). CONCLUSIONS Sunitinib and sorafenib are often administered in short duration, and many patients receive sequential and/or combination therapy despite a lack of clinical trial data supporting this practice. Given the expense of oral TT, these data highlight the need to better understand both real-world explanations for short-term treatment regimens (e.g., adherence, toxicity, disease progression) and the actual clinical efficacy of off-label treatment regimens. Ann Arbor, MI© 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e137 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Christopher Filson More articles by this author Rodney Dunn More articles by this author David Miller More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...