PD34-10 IMPACT OF DAROLUTAMIDE ON LOCAL SYMPTOMS IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) III (PD34)1 Sep 2021PD34-10 IMPACT OF DAROLUTAMIDE ON LOCAL SYMPTOMS IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER Neal Shore, Arnulf Stenzl, Christopher Pieczonka, Zachary Klaassen, William Aronson, Lawrence Karsh, Charles Ryan, Marina Miskic, Shankar Srinivasan, Ateesha Mohamed, and Frank Verholen ShoreNeal Shore More articles by this author , StenzlArnulf Stenzl PieczonkaChristopher Pieczonka KlaassenZachary Klaassen AronsonWilliam Aronson KarshLawrence Karsh RyanCharles Ryan MiskicMarina Miskic SrinivasanShankar Srinivasan MohamedAteesha Mohamed VerholenFrank View All Author Informationhttps://doi.org/10.1097/JU.0000000000002038.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Darolutamide (DARO), a structurally distinct androgen receptor inhibitor, significantly reduced the risk metastasis death vs placebo (PBO) in phase 3 ARAMIS trial (NCT02200614). We assessed relationship between prostate-specific antigen (PSA) response urinary bowel adverse events (AEs), time deterioration quality life (QoL), prostate cancer (PC)–related invasive procedures ARAMIS. METHODS: Men with nonmetastatic castration-resistant were randomized 2:1 DARO (n=955) or PBO (n=554) while continuing deprivation therapy. The proportion patients (pts) achieving declines PSA from baseline week 16 >90%, 50%–90%, <50% determined correlated AEs. Time QoL using European Organization for Research Treatment Cancer Quality Life Questionnaire (EORTC QLQ-PR25) subscales Functional Assessment Therapy–Prostate, Prostate Subscale (FACT-P PCS) was defined as first occurrence minimally important difference ≥3 point decline baseline, respectively, calculated Kaplan-Meier estimators stratified Cox proportional hazard models. RESULTS: Prior prostatectomy radiotherapy reported 25.0% 18.5% pts 24.2% 16.1% pts, respectively. incidence AEs showed minimal tract infection (5.3% 5.6%), abnormally frequent urination (4.4% 3.2%), hematuria (4.5% 5.4%) but lower retention (3.8% 7.4%) dysuria (2.6% 5.2%). Among greater (>90%, 50%–90% <50%) associated (2.2%, 4.2% 5.1%) (0.5%, 3.2%, 5.1%), delayed EORTC-QLQ-PR25 symptoms (25.8 14.8 mo; ratio [HR] 0.64; 95% confidence interval [CI] 0.54–0.76; p<0.01) (18.4 11.5 HR 0.78; CI 0.66–0.92; FACT-P PCS (11.1 7.9 0.80; 0.70–0.91; p=0.0005). Fewer receiving (4.7%) (9.6%) underwent PC-related procedures, procedure longer (HR 0.416; 0.279–0.620; p<0.001). CONCLUSIONS: reduction local symptoms, patient related locally procedures. Source Funding: Bayer AG Orion Pharma © 2021 American Urological Association Education Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e586-e587 Advertisement Copyright & Permissions© Inc.MetricsAuthor Information Expand Loading ...