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648 BENEFIT OF DENOSUMAB THERAPY IN PATIENTS WITH BONE METASTASES FROM CASTRATE RESISTANT PROSTATE CANCER: A NUMBER-NEEDED-TO-TREAT (NNT) ANALYSIS

2011; Lippincott Williams & Wilkins; Volume: 185; Issue: 4S Linguagem: Inglês

10.1016/j.juro.2011.02.1550

1527-3792

Kurt Miller, Karim Fizazi, Matthew R. Smith, Jose Pablo Moroto, Laurence Klotz, Janet E. Brown, Teuvo L.J. Tammela, Neal D. Shore, Chunlei Ke, Karen Chung, Carsten Goessl,

Radiopharmaceutical Chemistry and Applications

You have accessJournal of UrologyProstate Cancer: Advanced1 Apr 2011648 BENEFIT OF DENOSUMAB THERAPY IN PATIENTS WITH BONE METASTASES FROM CASTRATE RESISTANT PROSTATE CANCER: A NUMBER-NEEDED-TO-TREAT (NNT) ANALYSIS Kurt Miller, Karim Fizazi, Matthew Smith, Jose Pablo Moroto, Laurence Klotz, Janet Brown, Teuvo LJ Tammela, Neal Shore, Chunlei Ke, Karen Chung, and Carsten Goessl Kurt MillerKurt Miller Berlin, Germany More articles by this author , Karim FizaziKarim Fizazi Paris, France More articles by this author , Matthew SmithMatthew Smith Boston, MA More articles by this author , Jose Pablo MorotoJose Pablo Moroto Barcelona, Spain More articles by this author , Laurence KlotzLaurence Klotz Toronto, Canada More articles by this author , Janet BrownJanet Brown Leeds, United Kingdom More articles by this author , Teuvo LJ TammelaTeuvo LJ Tammela Tampere, Finland More articles by this author , Neal ShoreNeal Shore Myrtle Beach, SC More articles by this author , Chunlei KeChunlei Ke Thousand Oaks, CA More articles by this author , Karen ChungKaren Chung Thousand Oaks, CA More articles by this author , and Carsten GoesslCarsten Goessl Thousand Oaks, CA More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.1550AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Denosumab, a fully human monoclonal anti-RANKL antibody, was superior to zoledronic acid (ZA) in preventing skeletal-related events (SREs) in a randomized trial of prostate cancer patients with bone metastases. The number needed to treat (NNT) is a widely used method of expressing the benefit from a particular intervention. The NNT quantifies the benefit of a treatment by describing how many patients or patient-years of treatment are needed to prevent 1 undesirable event (eg, SRE) or achieve 1 beneficial outcome. METHODS In this randomized, double-blind, double-dummy study, eligible castrate-resistant prostate cancer patients with bone metastases were randomized to receive either subcutaneous denosumab 120 mg (N = 950) or intravenous ZA 4 mg (N = 951) every 4 weeks. Supplemental calcium ≥ 500 mg and vitamin D ≥ 400 IU were recommended for all patients. The NNT for denosumab compared with ZA was calculated using first and subsequent SREs and was reported in patient-years, which describes the benefit of treatment regardless of treatment duration. RESULTS In this head-to-head trial, denosumab reduced the risk of SREs by 18% vs ZA; P = 0.008. Seven hundred eighty SREs occurred in 1,045 patient-years in the denosumab arm; 943 SREs occurred in 996 patient-years in the ZA treatment arm. On average, compared with ZA, the NNT analysis demonstrates that treatment of 5 patients with denosumab would prevent an additional SRE (first or subsequent) per year. CONCLUSIONS The low NNT for each SRE prevented suggests relatively high therapeutic efficacy for denosumab in men with prostate cancer and bone metastases compared to ZA. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e262 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kurt Miller Berlin, Germany More articles by this author Karim Fizazi Paris, France More articles by this author Matthew Smith Boston, MA More articles by this author Jose Pablo Moroto Barcelona, Spain More articles by this author Laurence Klotz Toronto, Canada More articles by this author Janet Brown Leeds, United Kingdom More articles by this author Teuvo LJ Tammela Tampere, Finland More articles by this author Neal Shore Myrtle Beach, SC More articles by this author Chunlei Ke Thousand Oaks, CA More articles by this author Karen Chung Thousand Oaks, CA More articles by this author Carsten Goessl Thousand Oaks, CA More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...