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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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Autores principales: Uemura, Hiroji, Satoh, Takefumi, Tsumura, Hideyasu, Arai, Gaku, Imanaka, Keiichiro, Shibayama, Kazuhiro, Fujii, Koji, Rooney, Brendan, Lopez-Gitlitz, Angela, Espina, Byron, Perez-Ruixo, Carlos, Small, Eric J., Smith, Matthew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Asian Pacific Prostate Society 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7767934/
https://www.ncbi.nlm.nih.gov/pubmed/33425798
http://dx.doi.org/10.1016/j.prnil.2020.05.002
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author Uemura, Hiroji
Satoh, Takefumi
Tsumura, Hideyasu
Arai, Gaku
Imanaka, Keiichiro
Shibayama, Kazuhiro
Fujii, Koji
Rooney, Brendan
Lopez-Gitlitz, Angela
Espina, Byron
Perez-Ruixo, Carlos
Small, Eric J.
Smith, Matthew
author_facet Uemura, Hiroji
Satoh, Takefumi
Tsumura, Hideyasu
Arai, Gaku
Imanaka, Keiichiro
Shibayama, Kazuhiro
Fujii, Koji
Rooney, Brendan
Lopez-Gitlitz, Angela
Espina, Byron
Perez-Ruixo, Carlos
Small, Eric J.
Smith, Matthew
author_sort Uemura, Hiroji
collection PubMed
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.
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spelling pubmed-77679342021-01-07 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 Uemura, Hiroji Satoh, Takefumi Tsumura, Hideyasu Arai, Gaku Imanaka, Keiichiro Shibayama, Kazuhiro Fujii, Koji Rooney, Brendan Lopez-Gitlitz, Angela Espina, Byron Perez-Ruixo, Carlos Small, Eric J. Smith, Matthew Prostate Int Research Article 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. Asian Pacific Prostate Society 2020-12 2020-05-28 /pmc/articles/PMC7767934/ /pubmed/33425798 http://dx.doi.org/10.1016/j.prnil.2020.05.002 Text en © 2020 Asian Pacific Prostate Society. Published by Elsevier B.V. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Research Article
Uemura, Hiroji
Satoh, Takefumi
Tsumura, Hideyasu
Arai, Gaku
Imanaka, Keiichiro
Shibayama, Kazuhiro
Fujii, Koji
Rooney, Brendan
Lopez-Gitlitz, Angela
Espina, Byron
Perez-Ruixo, Carlos
Small, Eric J.
Smith, Matthew
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 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 Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7767934/
https://www.ncbi.nlm.nih.gov/pubmed/33425798
http://dx.doi.org/10.1016/j.prnil.2020.05.002
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