Pd10-11 Prostate-specific Antigen (psa) Outcomes in Patients (pts) With Nonmetastatic Castration-resistant Prostate Cancer (nmcrpc) Treated With Apalutamide (apa): Results From Phase 3 Spartan Study
Year: 2018
Type: article
Abstract: You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) I1 Apr 2018PD10-11 PROSTATE-SPECIFIC ANTIGEN (PSA) OUTCOMES IN PATIENTS (PTS) WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) TREATED WITH APALUTAMIDE (APA): RESULTS FROM PHASE 3 SPARTAN STUDY Eric J. Small, Ji Youl Lee, Angela Lopez-Gitlitz, Fred Saad, Brendan Rooney, Boris A. Hadaschik, Hiroji Uemura, Youyi Shu, Margaret Yu, and Matthew R. Smith Eric J. SmallEric J. Small 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 , Fred SaadFred Saad More articles by this author , Brendan RooneyBrendan Rooney More articles by this author , Boris A. HadaschikBoris A. Hadaschik More articles by this author , Hiroji UemuraHiroji Uemura More articles by this author , Youyi ShuYouyi Shu More articles by this author , Margaret YuMargaret Yu More articles by this author , and Matthew R. SmithMatthew R. Smith More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.621AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES SPARTAN is a randomized phase 3, placebo (PBO)-controlled study that evaluates the impact of APA, an orally administered next-generation androgen receptor inhibitor, on metastasis prevention (metastasis-free survival [MFS]) in men with nmCRPC and a rapidly rising PSA. In SPARTAN, APA significantly improved median MFS by 2 years. APA also significantly improved time to metastasis, progression-free survival, and time to symptomatic progression; was associated with a favorable trend of improved overall survival; and significantly improved progression-free survival on second therapy. PSA response and PSA progression were followed to assess treatment responses. Detailed information on PSA outcomes is presented. METHODS Pts enrolled in SPARTAN were randomized 2:1 to APA (240 mg QD) or PBO. Androgen deprivation therapy was continued in both groups. PSA was assessed by a central laboratory and blinded to the pts and investigators. PSA response was defined as a ≥ 50% decline from baseline and confirmed on a subsequent measurement at least 4 weeks later. Time to PSA progression was defined as the time from randomization to PSA progression according to Prostate Cancer Working Group 2 criteria. The Cochran-Mantel-Haenszel test was used for the PSA response analysis. Kaplan-Meier methods were used to estimate median time to PSA progression. Cox proportional hazard models were used to estimate the HR and 95% CI. RESULTS In total, 1207 pts were randomized (806 to APA, 401 to PBO). Baseline median PSA doubling time was 4.4 and 4.5 mos, and median baseline PSA was 7.78 and 7.96 ng/mL in the APA and PBO groups, respectively. Confirmed PSA response was observed in 90% and 2% of pts in the APA and PBO groups, respectively (RR = 40.09; 95% CI, 20.99-76.58; p < 0.0001). The median time to PSA response was 29 (range, 8-310) days in the APA group. At 12 weeks after randomization, median PSA decreased by 90% in the APA group and increased by 40% in the PBO group. A ≥ 90% maximum decline in PSA from baseline at any time on study was observed in 66% and 1% of pts in the APA and PBO groups, respectively. APA significantly decreased the risk of PSA progression by 94% compared with PBO (not reached vs 3.71 mos; HR = 0.064; 95% CI, 0.052-0.080; p < 0.0001). CONCLUSIONS APA significantly prolonged MFS by 2 years in men with nmCRPC and a rapidly rising PSA. Here we demonstrate that APA significantly reduces the risk of PSA progression, with a rapid median PSA response of 29 days in the APA group. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e232 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Eric J. Small More articles by this author Ji Youl Lee More articles by this author Angela Lopez-Gitlitz More articles by this author Fred Saad More articles by this author Brendan Rooney More articles by this author Boris A. Hadaschik More articles by this author Hiroji Uemura More articles by this author Youyi Shu More articles by this author Margaret Yu More articles by this author Matthew R. Smith More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...
Source: The Journal of Urology
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2795566316