Adding apalutamide to androgen-deprivation therapy (ADT) resulted in a rapid (at 3- and 6-mo treatment) and deep prostate-specific antigen (PSA) decline (to ≤0.2 ng/ml or ≥90% from baseline), improved overall survival, reduced risk of disease progression, and prolonged health-related quality of life (HRQoL) in nonmetastatic castration-resistant prostate cancer (nmCRPC) in SPARTAN and metastatic castration-sensitive PC (mCSPC) in TITAN.
To evaluate the association of a rapid, deep PSA decline at 3 and 6 mo achieved with the addition of apalutamide to ADT with patient-reported outcomes (PROs) in SPARTAN and TITAN.
A post hoc analysis of SPARTAN and TITAN PRO data was performed.
Apalutamide versus placebo plus concurrent ADT.
PROs were assessed using Functional Assessment of Cancer Therapy-Prostate (FACT-P; SPARTAN and TITAN), Brief Pain Inventory-Short Form (BPI-SF; TITAN), and Brief Fatigue Inventory (BFI; TITAN) at baseline, prespecified cycles during treatment, and after progression for ≤1 yr. The association between a deep PSA decline at landmark 3 or 6 mo of apalutamide and the time to worsening of PROs was assessed using the Kaplan-Meier methodology and Cox proportional-hazard modeling.
Among 806 SPARTAN and 525 TITAN apalutamide-treated patients, the median treatment duration was 32.9 and 39.3 mo, respectively. Patients achieving a deep PSA decline at 3 mo had longer time to worsening in FACT-P total, FACT-P physical well-being, BPI-SF worst pain intensity, or BFI worst fatigue intensity. The 6-mo PSA decline results were similar. Limitations of patient characteristics in clinical studies should be considered.
Attaining a deep and rapid PSA decline at 3 mo with apalutamide plus ADT was associated with longer preservation of overall HRQoL and physical well-being in nmCRPC and mCSPC.
Quality of life is maintained in individuals with advanced prostate cancer who achieve a deep prostate-specific antigen decline at 3 mo of apalutamide plus drugs that lower male sex hormones.
European urology oncology. 2023 Dec 09 [Epub ahead of print]
Eric J Small, Kim N Chi, Simon Chowdhury, Katherine B Bevans, Amitabha Bhaumik, Fred Saad, Byung Ha Chung, Lawrence I Karsh, Stéphane Oudard, Peter De Porre, Sabine D Brookman-May, Sharon A McCarthy, Suneel D Mundle, Hirotsugu Uemura, Matthew R Smith, Neeraj Agarwal
Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA. Electronic address: ., BC Cancer and Vancouver Prostate Centre, Vancouver, BC, Canada., Guy's, King's, and St. Thomas' Hospitals and Sarah Cannon Research Institute, London, UK., Janssen Global Commercial Strategy Organization, Horsham, PA, USA., Janssen Research & Development, Titusville, NJ, USA., Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada., Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea., The Urology Center of Colorado, Denver, CO, USA., Georges Pompidou Hospital, Université Paris Descartes, Paris, France., Janssen Research & Development, Beerse, Belgium., Ludwig-Maximilians-University, Munich, Germany; Janssen Research & Development, Spring House, PA, USA., Janssen Research & Development, Raritan, NJ, USA., Kindai University Faculty of Medicine, Osaka, Japan., Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA., Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.