MP34-19 EFFICACY AND SAFETY OF APALUTAMIDE (APA) IN NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) PATIENTS (PTS) WITH OR WITHOUT PRIOR RADICAL PROSTATECTOMY (RP) AND/OR EXTERNAL RADIOTHERAPY (XRT): POST HOC ANALYSIS OF SPARTAN

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) IV (MP34)1 Apr 2019MP34-19 EFFICACY AND SAFETY OF APALUTAMIDE (APA) IN NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) PATIENTS (PTS) WITH OR WITHOUT PRIOR RADICAL PROSTATECTOMY (RP) AND/OR EXTERNAL RADIOTHERAPY (XRT): POST HOC ANALYSIS OF SPARTAN Boris A. Hadaschik*, Fred Saad, Julie N. Graff, David Olmos, Stephane Oudard, Paul N. Mainwaring, Hiroji Uemura, Ji Youl Lee, Angela Lopez-Gitlitz, Amitabha Bhaumik, Anil Londhe, Shinta Cheng, Mary B. Todd, Eric J. Small, and Matthew R. Smith Boris A. Hadaschik*Boris A. Hadaschik* More articles by this author , Fred SaadFred Saad More articles by this author , Julie N. GraffJulie N. Graff More articles by this author , David OlmosDavid Olmos More articles by this author , Stephane OudardStephane Oudard More articles by this author , Paul N. MainwaringPaul N. Mainwaring More articles by this author , Hiroji UemuraHiroji Uemura More articles by this author , Ji Youl LeeJi Youl Lee More articles by this author , Angela Lopez-GitlitzAngela Lopez-Gitlitz More articles by this author , Amitabha BhaumikAmitabha Bhaumik More articles by this author , Anil LondheAnil Londhe More articles by this author , Shinta ChengShinta Cheng More articles by this author , Mary B. ToddMary B. Todd More articles by this author , Eric J. SmallEric J. Small More articles by this author , and Matthew R. SmithMatthew R. Smith More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555933.20995.42AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: SPARTAN, a randomized phase 3 placebo (PBO)-controlled study in pts with high-risk nmCRPC, demonstrated that APA added to androgen deprivation therapy (ADT) prolonged metastasis-free survival (MFS) by > 2 yrs (median 40.5 vs 16.2 mo; HR, 0.28; p < 0.0001) and provided a 55% reduction in the risk of symptomatic progression (HR, 0.45; 95% CI, 0.32-0.63; p < 0.0001) (Smith et al. N Engl J Med 2018). We examined whether treatment with APA, a next-generation androgen receptor inhibitor, provided the same benefit and safety profile in pts with or without prior RP and/or XRT (RP/XRT). METHODS: Pts with nmCRPC and a high risk of developing metastasis (prostate-specific antigen doubling time [PSADT] ≤ 10 mo) were randomized 2:1 to APA (240 mg QD) + ADT or PBO + ADT. Pt outcomes were evaluated based on any RP/XRT prior to the study. Cox proportional hazard analysis was used to estimate the HR and 95% CI for MFS. RESULTS: 41% of pts in each arm (334/806 APA; 166/401 PBO) had prior RP/XRT. Pts with prior RP/XRT were younger with longer time since diagnosis, had lower PSA values, lower ECOG and Gleason scores, and were less likely to have renal impairment. Despite these baseline advantages in the PBO group, pts with prior RP/XRT had poorer outcomes. MFS was significantly shorter for PBO pts with vs without prior local therapy (HR, 1.73; p = 0.0002). This negative prognosis for pts with prior RP/XRT was overcome with APA (HR, 0.80; p = 0.13), which delayed development of metastases by 68%-84% vs PBO (Table). The relative magnitude of improvement with APA vs PBO was highest in pts with prior local therapy. No impact of prior local therapy was observed on incidence of grade 3/4 treatment-emergent adverse events with APA and PBO. Incidence of falls, fractures, hypothyroidism, seizures, and skin rash was similar in pts with or without prior RP/XRT. CONCLUSIONS: Regardless of prior local therapy, pts received highly significant MFS benefit from treatment with APA. Prior therapy did not have an impact on tolerability of APA. Source of Funding: Funding: Janssen Research & Development Essen, Germany; Montréal, Canada; Portland, OR; Madrid, Spain; Paris, France; Brisbane, Australia; Yokohama, Japan; Seoul, Korea, Republic of; Los Angeles, CA; Yardley, PA; Titusville, NJ; Raritan, NJ; San Francisco, CA; Boston, MA© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e502-e503 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Boris A. Hadaschik* More articles by this author Fred Saad More articles by this author Julie N. Graff More articles by this author David Olmos More articles by this author Stephane Oudard More articles by this author Paul N. Mainwaring More articles by this author Hiroji Uemura More articles by this author Ji Youl Lee More articles by this author Angela Lopez-Gitlitz More articles by this author Amitabha Bhaumik More articles by this author Anil Londhe More articles by this author Shinta Cheng More articles by this author Mary B. Todd More articles by this author Eric J. Small More articles by this author Matthew R. Smith More articles by this author Expand All Advertisement PDF downloadLoading ...

Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.