PD10-11 APALUTAMIDE FOR METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER IN TITAN: PROGNOSTIC IMPORTANCE OF PROSTATE-SPECIFIC ANTIGEN RESPONSES

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) I (PD10)1 Apr 2020PD10-11 APALUTAMIDE FOR METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER IN TITAN: PROGNOSTIC IMPORTANCE OF PROSTATE-SPECIFIC ANTIGEN RESPONSES Simon Chowdhury*, Anders Bjartell, Neeraj Agarwal, Byung Ha Chung, Robert W. Given, Andrea J. Pereira de Santana Gomes, Axel S. Merseburger, Mustafa Özgüroğlu, Alvaro Juárez Soto, Hirotsugu Uemura, Dingwei Ye, Angela Lopez-Gitlitz, Anil Londhe, Suneel Mundle, Julie S. Larsen, Sharon McCarthy, and Kim N. Chi Simon Chowdhury*Simon Chowdhury* , Anders BjartellAnders Bjartell , Neeraj AgarwalNeeraj Agarwal , Byung Ha ChungByung Ha Chung , Robert W. GivenRobert W. Given , Andrea J. Pereira de Santana GomesAndrea J. Pereira de Santana Gomes , Axel S. MerseburgerAxel S. Merseburger , Mustafa ÖzgüroğluMustafa Özgüroğlu , Alvaro Juárez SotoAlvaro Juárez Soto , Hirotsugu UemuraHirotsugu Uemura , Dingwei YeDingwei Ye , Angela Lopez-GitlitzAngela Lopez-Gitlitz , Anil LondheAnil Londhe , Suneel MundleSuneel Mundle , Julie S. LarsenJulie S. Larsen , Sharon McCarthySharon McCarthy , and Kim N. ChiKim N. Chi View All Author Informationhttps://doi.org/10.1097/JU.0000000000000844.011AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: TITAN showed that apalutamide (APA) + androgen deprivation therapy (ADT) improves overall survival (OS), radiographic progression-free survival (rPFS), and time to prostate-specific antigen (PSA) progression in a broad population of patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) (Chi et al. NEJM 2019). This post hoc analysis evaluates the depth of PSA reduction and long-term outcomes in TITAN. METHODS: 1052 pts with mCSPC receiving ADT were randomized 1:1 to APA (240 mg/d, n = 525) or placebo (PBO, n = 527). Depth of PSA response was evaluated by measuring undetectable PSA (≤ 0.2 ng/mL), ≥ 50% ↓ (decline), or ≥ 90% ↓ from baseline (BL, at study randomization). Time to castration-resistant prostate cancer (CRPC) was a composite of the time to PSA progression (per Prostate Cancer Working Group criteria), skeletal-related event, or radiographic progression, whichever came first. Trial registration: NCT02489318 RESULTS: Pts were randomized after initiation of ADT (median 1.8 mo). BL PSA levels were comparable (median: APA, 5.97 ng/mL, PBO, 4.02 ng/mL). Within 3 mo of APA initiation, significantly more pts achieved undetectable PSA (≤ 0.2 ng/mL) in the APA group than in the PBO group (Table 1, p ≤ 0.0001 for all). The median nadir attained following APA was 0.08 ng/mL, at a median 4.63 mo. Increased depth of PSA response within 3 mo of initiation of APA resulted in significantly better outcomes compared with no response (< 50% PSA ↓, Table 2; p ≤ 0.0001 for all). Best response of undetectable PSA levels (≤ 0.2 ng/mL) after 3 mo of APA treatment resulted in 94% risk reduction in OS and rPFS and 88% risk reduction in time to CRPC compared with no response (< 50% PSA ↓). CONCLUSIONS: The magnitude of PSA response is significantly improved with the addition of APA to ADT in pts with mCSPC. Deep and rapid PSA response with APA + ADT was associated with improved long-term outcomes indicating prognostic impact. Source of Funding: Janssen Research & Development © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e250-e250 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Simon Chowdhury* More articles by this author Anders Bjartell More articles by this author Neeraj Agarwal More articles by this author Byung Ha Chung More articles by this author Robert W. Given More articles by this author Andrea J. Pereira de Santana Gomes More articles by this author Axel S. Merseburger More articles by this author Mustafa Özgüroğlu More articles by this author Alvaro Juárez Soto More articles by this author Hirotsugu Uemura More articles by this author Dingwei Ye More articles by this author Angela Lopez-Gitlitz More articles by this author Anil Londhe More articles by this author Suneel Mundle More articles by this author Julie S. Larsen More articles by this author Sharon McCarthy More articles by this author Kim N. Chi More articles by this author Expand All Advertisement PDF downloadLoading ...