Efficacy and safety of apalutamide in Japanese patients with nonmetastatic castration-resistant prostate cancer: a subgroup analysis of a randomized, double-blind, placebo-controlled, Phase-3 study
| Autor: | Brendan Rooney, Matthew R. Smith, Byron M. Espina, Gaku Arai, Eric J. Small, Angela Lopez-Gitlitz, Takefumi Satoh, Hiroji Uemura, Carlos Perez-Ruixo, Hideyasu Tsumura, Keiichiro Imanaka, Kazuhiro Shibayama, Koji Fujii |
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| Rok vydání: | 2020 |
| Předmět: |
Oncology
medicine.medical_specialty Urology Population 030232 urology & nephrology Phases of clinical research Subgroup analysis lcsh:RC870-923 Placebo Androgen deprivation therapy 03 medical and health sciences chemistry.chemical_compound Prostate cancer 0302 clinical medicine Internal medicine Apalutamide Medicine education education.field_of_study business.industry Nonmetastatic castration-resistant prostate cancer lcsh:Diseases of the genitourinary system. Urology medicine.disease Prostate-specific antigen chemistry Metastasis-free survival 030220 oncology & carcinogenesis business Research Article |
| Zdroj: | Prostate International Prostate International, Vol 8, Iss 4, Pp 190-197 (2020) |
| ISSN: | 2287-8882 |
| Popis: | Background In the global Phase-3 Selective Prostate Androgen Receptor Targeting with ARN-509 study, apalutamide plus ongoing androgen deprivation therapy (ADT) significantly increased metastasis-free survival (MFS) and improved other clinical outcomes in men with nonmetastatic castration-resistant prostate cancer (nm-CRPC) who were at high risk of developing metastases. In this subpopulation analysis of Selective Prostate Androgen Receptor Targeting with ARN-509 study, the efficacy and safety of apalutamide plus ADT were evaluated in Japanese patients with nm-CRPC. Methods The primary efficacy end point was MFS. Secondary efficacy end points were time to metastasis, progression-free survival, symptomatic progression, initiation of cytotoxic chemotherapy, and overall survival. Safety and pharmacokinetic parameters were also assessed. Results Fifty-five Japanese patients with ongoing ADT were randomized (apalutamide: n = 34, placebo: n = 21). Median treatment duration was 5.7 months in the apalutamide group and 11.0 months in the placebo group. Median MFS was not reached in the apalutamide group (95% confidence interval: 10.97, not estimable) and was 18.23 months (95% confidence interval: 11.04, 18.50) in the placebo group. Secondary end points were improved in the apalutamide group. The safety profile of apalutamide with ADT was comparable with the global population, and no new safety signals were identified in this Japanese subpopulation. Although, apalutamide exposure tended to be higher in the Japanese subpopulation compared with the non-Japanese population, this was likely to be explained by body weight and considered not clinically meaningful. Conclusion In the Japanese subpopulation, treatment with apalutamide with ADT resulted in favorable efficacy outcomes with comparable benefit-risk profile to the global population with nm-CRPC who are at high-risk of developing metastases. |
| Databáze: | OpenAIRE |
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