Journal Article

Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from Phase 3 randomised clinical studies TITAN and SPARTAN

Shen, John, Feyerabend, Susan, Rooney, Brendan, Graff, Julie N., Agarwal, Neeraj, Saad, Fred, McCarthy, Sharon A., Gartrell, Benjamin A., Karsh, Lawrence I., Smith, Matthew R., Chowdhury, Simon, Small, Eric J., Brookman-May, Sabine D., Bevans, Katherine B., Bhaumik, Amitabha, Mundle, Suneel D., Oudard, Stéphane, Chi, Kim N., Pieczonka, Christopher M.

2024

Overview

Background 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. Methods 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. Results 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. Conclusions Apalutamide plus ADT was an effective and well-tolerated option maintaining HRQoL in patients with mCSPC and nmCRPC regardless of age. Clinical trial registration TITAN (NCT02489318); SPARTAN (NCT01946204).

• Publisher: Nature Publishing Group UK,Nature Publishing Group
• Subject: 692/308/409 / 692/4028/67/589/466 / Age / Age groups / Aged / Androgen Antagonists - therapeutic use / Biomedical and Life Sciences / Biomedicine / Cancer Research / Castration / Clinical trials / Drug Resistance / Epidemiology / Humans / Male / Metastases / Metastasis / Molecular Medicine / Older people / Oncology / Patients / Prostate cancer / Prostate-specific antigen / Prostatic Neoplasms, Castration-Resistant - pathology / Quality of Life / Statistical analysis / Survival / Thiohydantoins - adverse effects / Well being