PD10-10 IMPACT OF BASELINE DISEASE VOLUME AND PRIOR DOCETAXEL THERAPY ON PROSTATE-SPECIFIC ANTIGEN-RELATED OUTCOMES IN PATIENTS WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER TREATED WITH ENZALUTAMIDE PLUS ANDROGEN DEPRIVATION THERAPY

Abstract

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) I (PD10)1 Apr 2020PD10-10 IMPACT OF BASELINE DISEASE VOLUME AND PRIOR DOCETAXEL THERAPY ON PROSTATE-SPECIFIC ANTIGEN-RELATED OUTCOMES IN PATIENTS WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER TREATED WITH ENZALUTAMIDE PLUS ANDROGEN DEPRIVATION THERAPY Neal D. Shore*, E. David Crawford, Russell Z. Szmulewitz, Daniel Petrylak, Jeffrey Holzbeierlein, Arnauld Villers, Arun Azad, Antonio Alcaraz, Boris Alekseev, Taro Iguchi, Francisco Gomez-Veiga, Brad Rosbrook, Benoit Baron, Gabriel P. Haas, Arnulf Stenzl, and Andrew J. Armstrong Neal D. Shore*Neal D. Shore* More articles by this author , E. David CrawfordE. David Crawford More articles by this author , Russell Z. SzmulewitzRussell Z. Szmulewitz More articles by this author , Daniel PetrylakDaniel Petrylak More articles by this author , Jeffrey HolzbeierleinJeffrey Holzbeierlein More articles by this author , Arnauld VillersArnauld Villers More articles by this author , Arun AzadArun Azad More articles by this author , Antonio AlcarazAntonio Alcaraz More articles by this author , Boris AlekseevBoris Alekseev More articles by this author , Taro IguchiTaro Iguchi More articles by this author , Francisco Gomez-VeigaFrancisco Gomez-Veiga More articles by this author , Brad RosbrookBrad Rosbrook More articles by this author , Benoit BaronBenoit Baron More articles by this author , Gabriel P. HaasGabriel P. Haas More articles by this author , Arnulf StenzlArnulf Stenzl 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.0000000000000844.010AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Enzalutamide (ENZA) + androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death in men with metastatic hormone-sensitive prostate cancer (mHSPC), regardless of baseline prostate-specific antigen (PSA) levels (ARCHES; NCT02677896). Here, we further assess PSA-related outcomes in patients enrolled in ARCHES by disease volume and prior docetaxel therapy at study entry. METHODS: Patients with mHSPC were randomized 1:1 to receive ENZA (160 mg/day) + ADT or placebo (PBO) + ADT. Primary endpoint was radiographic progression-free survival. Secondary endpoints included time to PSA progression and PSA undetectable rate. Post hoc analyses were performed based on disease volume and prior docetaxel at study entry, which were stratification factors, as well as on time to 50% PSA reduction and time to undetectable (<0.2 ng/mL) PSA. RESULTS: Of the overall population (n=1150), 423 (36.8%) patients had low-volume disease and 205 (17.8%) patients reported prior docetaxel use. ENZA + ADT significantly improved PSA-related outcomes versus PBO + ADT, regardless of disease volume or prior docetaxel use at study entry (Table). The proportion of patients with ≥50% PSA reduction from baseline ranged from 85–95% for ENZA + ADT and 18–66% for PBO + ADT across the different patient subgroups. CONCLUSIONS: ENZA + ADT provides improvements in all assessed PSA-related outcomes versus PBO + ADT in patients with mHSPC, irrespective of disease volume or prior docetaxel therapy, with the limitation that the true baseline PSA is unknown for some patients due to prior ADT use in this patient population. Source of Funding: This study was funded by Astellas Pharma Inc. and Pfizer Inc., the co-developers of enzalutamide. Medical writing and editorial assistance were provided by Lianne Young, BSc (Hons), and Jane Beck from Complete HealthVizion, funded by the study sponsors. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e249-e250 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Neal D. Shore* More articles by this author E. David Crawford More articles by this author Russell Z. Szmulewitz More articles by this author Daniel Petrylak More articles by this author Jeffrey Holzbeierlein More articles by this author Arnauld Villers More articles by this author Arun Azad More articles by this author Antonio Alcaraz More articles by this author Boris Alekseev More articles by this author Taro Iguchi More articles by this author Francisco Gomez-Veiga More articles by this author Brad Rosbrook More articles by this author Benoit Baron More articles by this author Gabriel P. Haas More articles by this author Arnulf Stenzl More articles by this author Andrew J. Armstrong More articles by this author Expand All Advertisement PDF downloadLoading ...