Apalutamide plus androgen-deprivation therapy (ADT) improved outcomes in metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant PC (nmCRPC) in the Phase 3 randomised TITAN and SPARTAN studies, respectively, and maintained health-related quality of life (HRQoL). Apalutamide treatment effect by patient age requires assessment.
Post-hoc analysis assessed patients receiving 240 mg/day apalutamide (525 TITAN and 806 SPARTAN) or placebo (527 TITAN and 401 SPARTAN) with ongoing ADT, stratified by age groups. Prostate-specific antigen declines, radiographic progression-free survival, metastasis-free survival, overall survival (OS), HRQoL and safety were assessed using descriptive statistics, Kaplan-Meier method, Cox proportional-hazards model and mixed-effects model for repeated measures.
Hazard ratios (95% confidence intervals) generally favoured apalutamide plus ADT versus ADT alone across all endpoints regardless of age; e.g., OS values were 0.57 (0.40-0.80), 0.70 (0.54-0.91) and 0.74 (0.40-1.39) (TITAN) and 0.39 (0.19-0.78), 0.89 (0.69-1.16) and 0.81 (0.58-1.15) (SPARTAN) in patients aged <65, 65-79 and ≥80 years. Regardless of age, apalutamide also maintained HRQoL and was tolerated well with a potential trend in rates of adverse events increasing with age. Limitations include post-hoc nature and variability in sample size of age groups.
Apalutamide plus ADT was an effective and well-tolerated option maintaining HRQoL in patients with mCSPC and nmCRPC regardless of age.
TITAN (NCT02489318); SPARTAN (NCT01946204).
British journal of cancer. 2023 Nov 11 [Epub ahead of print]
John Shen, Simon Chowdhury, Neeraj Agarwal, Lawrence I Karsh, Stéphane Oudard, Benjamin A Gartrell, Susan Feyerabend, Fred Saad, Christopher M Pieczonka, Kim N Chi, Sabine D Brookman-May, Brendan Rooney, Amitabha Bhaumik, Sharon A McCarthy, Katherine B Bevans, Suneel D Mundle, Eric J Small, Matthew R Smith, Julie N Graff
Jonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA, USA. ., Guy's, King's, and St. Thomas' Hospitals, and Sarah Cannon Research Institute, London, UK., Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA., The Urology Center of Colorado, Denver, CO, USA., Georges Pompidou Hospital, University of Paris Cité, Paris, France., Montefiore Medical Center, Bronx, NY, USA., Studienpraxis Urologie, Nürtingen, Germany., Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montréal, QC, Canada., Associated Medical Professionals of NY, Syracuse, NY, USA., BC Cancer and Vancouver Prostate Centre, Vancouver, BC, Canada., Ludwig-Maximilians-University (LMU), Munich, Germany., Janssen Research & Development, High Wycombe, UK., Janssen Research & Development, Titusville, NJ, USA., Janssen Research & Development, Raritan, NJ, USA., Janssen Research & Development, Horsham, PA, USA., Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA., Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA., VA Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.