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

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...

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Published in:British journal of cancer 2024-01, Vol.130 (1), p.73-81
Main Authors: Shen, John, Chowdhury, Simon, Agarwal, Neeraj, Karsh, Lawrence I., Oudard, Stéphane, Gartrell, Benjamin A., Feyerabend, Susan, Saad, Fred, Pieczonka, Christopher M., Chi, Kim N., Brookman-May, Sabine D., Rooney, Brendan, Bhaumik, Amitabha, McCarthy, Sharon A., Bevans, Katherine B., Mundle, Suneel D., Small, Eric J., Smith, Matthew R., Graff, Julie N.
Format: Article
Language:English
Subjects:
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
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Summary: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
ISSN:0007-0920
1532-1827
DOI:10.1038/s41416-023-02492-8