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• W3193252888 abstract "You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) III (PD34)1 Sep 2021PD34-07 ENZALUTAMIDE IN METASTATIC HORMONE-SENSITIVE PROSTATE CANCER PATIENTS WHO RECEIVED PRIOR ANTIANDROGEN THERAPY: POST HOC ANALYSIS OF ARCHES Neal D. Shore, Taro Iguchi, Arnauld Villers, Antonio Alcaraz, Francisco Gomez-Veiga, Arnulf Stenzl, Arun A. Azad, Boris Alekseev, Daniel P. Petrylak, Russell Z. Szmulewitz, Jeffrey Holzbeierlein, Brad Rosbrook, Fabian Zohren, Gabriel P. Haas, Georgia Gourgioti, Nader N. El-Chaar, and Andrew J. Armstrong Neal D. ShoreNeal D. Shore More articles by this author , Taro IguchiTaro Iguchi More articles by this author , Arnauld VillersArnauld Villers More articles by this author , Antonio AlcarazAntonio Alcaraz More articles by this author , Francisco Gomez-VeigaFrancisco Gomez-Veiga More articles by this author , Arnulf StenzlArnulf Stenzl More articles by this author , Arun A. AzadArun A. Azad More articles by this author , Boris AlekseevBoris Alekseev More articles by this author , Daniel P. PetrylakDaniel P. Petrylak More articles by this author , Russell Z. SzmulewitzRussell Z. Szmulewitz More articles by this author , Jeffrey HolzbeierleinJeffrey Holzbeierlein More articles by this author , Brad RosbrookBrad Rosbrook More articles by this author , Fabian ZohrenFabian Zohren More articles by this author , Gabriel P. HaasGabriel P. Haas More articles by this author , Georgia GourgiotiGeorgia Gourgioti More articles by this author , Nader N. El-ChaarNader N. El-Chaar More articles by this author , and Andrew J. ArmstrongAndrew J. Armstrong More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002038.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Enzalutamide (ENZA)+androgen deprivation therapy (ADT) significantly prolonged radiographic progression-free survival (rPFS) and improved key secondary clinical outcomes versus placebo (PBO)+ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), also referred to as metastatic castration-sensitive prostate cancer, in ARCHES (NCT02677896). This post hoc analysis aimed to evaluate the efficacy of ENZA+ADT versus PBO+ADT in patients who received prior antiandrogen (AA) therapy before study randomization. METHODS: Patients with mHSPC were randomized 1:1 to receive ENZA (160 mg/day)+ADT or PBO+ADT, stratified by disease volume and prior docetaxel. Primary endpoint was rPFS (based on central review). Secondary endpoints included time to prostate-specific antigen (PSA) progression, time to initiation of new antineoplastic therapy, and PSA undetectable rate (PSA <0.2 ng/ml). Prior first-generation AA (nilutamide, flutamide, and bicalutamide) were permitted if given concurrently with up to 6 months of ADT with luteinizing hormone-releasing hormone agonists/antagonists or bilateral orchiectomy prior to day 1. Post hoc analyses of the primary and secondary endpoints were performed based on prior/no AA and prior AA duration (≤1 month; >1 month). A sensitivity analysis was conducted on patients who received gonadotropin-releasing hormone analogs (GnRHa)+prior/no AA to account for potential confounding effects from GnRH antagonists and bilateral orchiectomies. RESULTS: Of the overall population (n=1150), 435 patients had received prior AA (94% bicalutamide; 6% flutamide), 169 of whom had received prior AA for >1 month and 384 of whom were on GnRHa. ENZA+ADT improved rPFS and secondary clinical outcomes versus PBO+ADT, regardless of prior AA (Table), prior AA duration, and GnRHa use. There were no significant differences in the safety profile of ENZA+ADT by prior AA use. These results were maintained in the GnRHa sensitivity analysis. CONCLUSIONS: ENZA+ADT improved rPFS and secondary clinical outcomes versus PBO+ADT in patients with mHSPC, irrespective of prior AA use, with no significant difference in safety profile. Source of Funding: Astellas Pharma Inc.; Pfizer Inc., the co-developers of enzalutamide. Editorial: Complete HealthVizion © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e585-e585 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Neal D. Shore More articles by this author Taro Iguchi More articles by this author Arnauld Villers More articles by this author Antonio Alcaraz More articles by this author Francisco Gomez-Veiga More articles by this author Arnulf Stenzl More articles by this author Arun A. Azad More articles by this author Boris Alekseev More articles by this author Daniel P. Petrylak More articles by this author Russell Z. Szmulewitz More articles by this author Jeffrey Holzbeierlein More articles by this author Brad Rosbrook More articles by this author Fabian Zohren More articles by this author Gabriel P. Haas More articles by this author Georgia Gourgioti More articles by this author Nader N. El-Chaar More articles by this author Andrew J. Armstrong More articles by this author Expand All Advertisement Loading ..." @default.
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• W3193252888 title "PD34-07 ENZALUTAMIDE IN METASTATIC HORMONE-SENSITIVE PROSTATE CANCER PATIENTS WHO RECEIVED PRIOR ANTIANDROGEN THERAPY: POST HOC ANALYSIS OF ARCHES" @default.
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