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
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...
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| Format: | Article |
| Language: | English |
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Elsevier
2020-12-01
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| Series: | Prostate International |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2287888220300301 |
| _version_ | 1797765575946010624 |
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| author | Hiroji Uemura Takefumi Satoh Hideyasu Tsumura Gaku Arai Keiichiro Imanaka Kazuhiro Shibayama Koji Fujii Brendan Rooney Angela Lopez-Gitlitz Byron Espina Carlos Perez-Ruixo Eric J. Small Matthew Smith |
| author_facet | Hiroji Uemura Takefumi Satoh Hideyasu Tsumura Gaku Arai Keiichiro Imanaka Kazuhiro Shibayama Koji Fujii Brendan Rooney Angela Lopez-Gitlitz Byron Espina Carlos Perez-Ruixo Eric J. Small Matthew Smith |
| author_sort | Hiroji Uemura |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T20:13:04Z |
| format | Article |
| id | doaj.art-d97fbd9a51004654a21352bf6702ce26 |
| institution | Directory Open Access Journal |
| issn | 2287-8882 |
| language | English |
| last_indexed | 2024-03-12T20:13:04Z |
| publishDate | 2020-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Prostate International |
| spelling | doaj.art-d97fbd9a51004654a21352bf6702ce262023-08-02T01:37:01ZengElsevierProstate International2287-88822020-12-0184190197Efficacy 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 studyHiroji Uemura0Takefumi Satoh1Hideyasu Tsumura2Gaku Arai3Keiichiro Imanaka4Kazuhiro Shibayama5Koji Fujii6Brendan Rooney7Angela Lopez-Gitlitz8Byron Espina9Carlos Perez-Ruixo10Eric J. Small11Matthew Smith12Yokohama City University Medical Center, Yokohama, Japan; Corresponding author. Department of Urology & Renal Transplantation, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama 232-0024, JapanDepartment of Urology, Kitasato University School of Medicine, Sagamihara, Kanagawa, JapanDepartment of Urology, Kitasato University School of Medicine, Sagamihara, Kanagawa, JapanDokkyo Medical University Saitama Medical Center, Koshigaya, Saitama, JapanJanssen Pharmaceutical K.K., Nishi-kanda Chiyoda-ku, Tokyo, JapanJanssen Pharmaceutical K.K., Nishi-kanda Chiyoda-ku, Tokyo, JapanJanssen Pharmaceutical K.K., Nishi-kanda Chiyoda-ku, Tokyo, JapanJanssen Research and Development, UKJanssen Research and Development, UKJanssen Research and Development, UKJanssen Research and Development, UKUniversity of California San Francisco, San Francisco, CA, USAMassachusetts General Hospital Cancer Center, Boston, MA, USABackground: 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.http://www.sciencedirect.com/science/article/pii/S2287888220300301ApalutamideMetastasis-free survivalNonmetastatic castration-resistant prostate cancerProstate-specific antigen |
| spellingShingle | Hiroji Uemura Takefumi Satoh Hideyasu Tsumura Gaku Arai Keiichiro Imanaka Kazuhiro Shibayama Koji Fujii Brendan Rooney Angela Lopez-Gitlitz Byron Espina Carlos Perez-Ruixo Eric J. Small Matthew Smith 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 Prostate International Apalutamide Metastasis-free survival Nonmetastatic castration-resistant prostate cancer Prostate-specific antigen |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Apalutamide Metastasis-free survival Nonmetastatic castration-resistant prostate cancer Prostate-specific antigen |
| url | http://www.sciencedirect.com/science/article/pii/S2287888220300301 |
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