MP87-18 ASSESSMENT OF CORTICOSTEROID (CS)-ASSOCIATED ADVERSE EVENTS (AES) WITH LONG-TERM (LT) EXPOSURE TO LOW-DOSE PREDNISONE (P) GIVEN WITH ABIRATERONE ACETATE (AA) TO METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) PATIENTS (PTS)

Abstract

You have accessJournal of UrologyProstate Cancer: Advanced III1 Apr 2015MP87-18 ASSESSMENT OF CORTICOSTEROID (CS)-ASSOCIATED ADVERSE EVENTS (AES) WITH LONG-TERM (LT) EXPOSURE TO LOW-DOSE PREDNISONE (P) GIVEN WITH ABIRATERONE ACETATE (AA) TO METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) PATIENTS (PTS) Leonard G. Gomella, Kim N. Chi, Johann S. de Bono, Karim Fizazi, Kurt Miller, Dana E. Rathkopf, Charles J. Ryan, Howard I. Scher, Neal D. Shore, Peter De Porre, Anil Londhe, Tracy McGowan, Nonko Pelhivanov, Robert Charnas, Mary B. Todd, and Bruce Montgomery Leonard G. GomellaLeonard G. Gomella More articles by this author , Kim N. ChiKim N. Chi More articles by this author , Johann S. de BonoJohann S. de Bono More articles by this author , Karim FizaziKarim Fizazi More articles by this author , Kurt MillerKurt Miller More articles by this author , Dana E. RathkopfDana E. Rathkopf More articles by this author , Charles J. RyanCharles J. Ryan More articles by this author , Howard I. ScherHoward I. Scher More articles by this author , Neal D. ShoreNeal D. Shore More articles by this author , Peter De PorrePeter De Porre More articles by this author , Anil LondheAnil Londhe More articles by this author , Tracy McGowanTracy McGowan More articles by this author , Nonko PelhivanovNonko Pelhivanov More articles by this author , Robert CharnasRobert Charnas More articles by this author , Mary B. ToddMary B. Todd More articles by this author , and Bruce MontgomeryBruce Montgomery More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.1963AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES AA is the prodrug of abiraterone, which inhibits CYP17A1 and testosterone synthesis and prolongs survival of mCRPC pts. A low dose of P is given when AA is administered to mCRPC pts. LT use of moderate-/high-dose CS has an established AE profile. We investigated whether LT use of low-dose P with or without AA led to CS-associated AEs. METHODS 2267 mCRPC pts in COU-AA-301 and COU-AA-302 received 5 mg bid P, representing 2006 pt-yrs of P exposure. 1333 pts received AA + P. We utilized an inclusive Standardized MedDRA Queries–oriented approach to identify 112 preferred terms for known CS-associated AEs from both databases. CS-associated AEs during each 3-mo exposure interval and across all exposure to P were assessed. RESULTS The overall incidence of CS-associated AEs for any P exposure was 25%, 26%, and 23% for all pts, AA + P, and P alone, respectively. The incidence of grade ≥ 3 CS-associated AEs with any P exposure was 5%, 5%, and 4% for all pts, AA + P, and P alone, respectively. The most common grade ≥ 3 CS-associated AEs occurring in ≥ 0.1% of all pts were hyperglycemia (2%), cataract (0.4%), diabetes mellitus (0.4%), gastrointestinal hemorrhage (0.3%), adrenal insufficiency (0.1%), hip fracture (0.1%), melena (0.1%), and osteoporotic spinal compression fracture (0.1%). The overall incidence of weight increase (grade 1 and 2 only) was 4%, 4%, and 5% for all pts, AA + P, and P alone, respectively. Most were grade 1 (3.4%). When assessed by duration of exposure (3-mo intervals up to ≥ 30 mo), grade ≥ 3 CS-associated AEs fluctuated between 1% and 2%, but no discernable trend was observed. The observed change in weight from baseline showed no apparent increase over time. CONCLUSIONS With over 2000 pt-yrs of exposure, low-dose P given with or without AA is associated with an overall low incidence of CS-associated AEs. The occurrence of CS-associated AEs remained low with increased duration of exposure to P. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e1091 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Leonard G. Gomella More articles by this author Kim N. Chi More articles by this author Johann S. de Bono More articles by this author Karim Fizazi More articles by this author Kurt Miller More articles by this author Dana E. Rathkopf More articles by this author Charles J. Ryan More articles by this author Howard I. Scher More articles by this author Neal D. Shore More articles by this author Peter De Porre More articles by this author Anil Londhe More articles by this author Tracy McGowan More articles by this author Nonko Pelhivanov More articles by this author Robert Charnas More articles by this author Mary B. Todd More articles by this author Bruce Montgomery More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...