You have accessJournal of UrologyProstate Cancer: Advanced III1 Apr 2015MP87-12 RADIUM-223 DICHLORIDE IN EXPANDED-ACCESS SETTING IN THE UNITED STATES: OVERALL AND CONCURRENT EXPERIENCE WITH ABIRATERONE OR ENZALUTAMIDE Neal Shore, Nicholas Vogelzang, Daniel Fernandez, Michael Morris, Andrei Iagaru, Alan Brown, Christopher Sweeney, Matthew R. Smith, Adam P. Dicker, Yu-Ning Wong, Keith Bangerter, Jeremy Gratt, Oana Petrenciuc, and Oliver Sartor Neal ShoreNeal Shore More articles by this author , Nicholas VogelzangNicholas Vogelzang More articles by this author , Daniel FernandezDaniel Fernandez More articles by this author , Michael MorrisMichael Morris More articles by this author , Andrei IagaruAndrei Iagaru More articles by this author , Alan BrownAlan Brown More articles by this author , Christopher SweeneyChristopher Sweeney More articles by this author , Matthew R. SmithMatthew R. Smith More articles by this author , Adam P. DickerAdam P. Dicker More articles by this author , Yu-Ning WongYu-Ning Wong More articles by this author , Keith BangerterKeith Bangerter More articles by this author , Jeremy GrattJeremy Gratt More articles by this author , Oana PetrenciucOana Petrenciuc More articles by this author , and Oliver SartorOliver Sartor More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.1957AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The aim of this prospective expanded-access program (EAP) was to monitor acute and long-term safety of radium-223 dichloride (Ra-223). Herein we provide experience with Ra-223. METHODS Patients with symptomatic bone-metastatic castration-resistant prostate cancer/hormone-resistant prostate cancer in the United States who were ineligible for or had prior docetaxel were enrolled. Treatment included Ra-223 50 kBq/kg intravenously q4wk for 6 cycles with concomitant standard of care. Primary end points were Eastern Cooperative Oncology Group performance score, symptomatic skeletal events (SSEs), and treatment-emergent adverse events (TEAEs). Exploratory end points included overall survival (OS). Analyses were conducted to assess safety and OS for the whole cohort and subgroups using concurrent enzalutamide (Enza) or abiraterone (Abi). RESULTS 184 patients were treated. Of these 120 (65%) had prior and 35 (19%) had concurrent Abi; 59 (32%) had prior and 25 (14%) had concurrent Enza. Baseline characteristics were generally balanced including the concurrent subgroups. 8 deaths occurred during treatment, none related to Ra-223. TEAEs occurring at ≥ 10% were anemia, fatigue, diarrhea, and nausea. The rate of grade 3-5 TEAEs was similar across concurrent (Abi 37%, Enza 36%) and prior subgroups (Abi 43%, Enza 42%) vs overall (41%). Median OS was 17 months. CONCLUSIONS In heavily pretreated patients in this EAP setting, Ra-223 was well tolerated with a longer survival than previously seen in phase 3 ALSYMPCA (15 mo). Concurrently administered with either Abi or Enza, Ra-223 was well tolerated, adding important information on concurrent use of Ra-223 and newer hormonal agents. Abi N = 35 Abi N = 35 Enza N = 25 Enza N = 25 Overall N = 184 Overall N = 184 n % n % n % Age, median, y 68 70 70 Race, white 31 89 23 92 169 92 Weight, median, kg 87 90 86 ECOG ≤ 1 35 100 24 96 165 90 Total ALP ≥ 220 U/L 8 23 8 32 56 30 Current bisphosphonate, yes 6 17 6 24 18 10 Prior docetaxel, yes 14 40 15 60 109 59 Pts receiving all 6 injections 20 57 15 60 81 44 © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e1088-e1089 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Neal Shore More articles by this author Nicholas Vogelzang More articles by this author Daniel Fernandez More articles by this author Michael Morris More articles by this author Andrei Iagaru More articles by this author Alan Brown More articles by this author Christopher Sweeney More articles by this author Matthew R. Smith More articles by this author Adam P. Dicker More articles by this author Yu-Ning Wong More articles by this author Keith Bangerter More articles by this author Jeremy Gratt More articles by this author Oana Petrenciuc More articles by this author Oliver Sartor More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...