Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis

There was a high medical need for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) when several next-generation anti-androgens (apalutamide, enzalutamide, and darolutamide) demonstrated clinically relevant delays in metastasis onset. However, to date, few publications have...

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Authors: Rodriguez-Vida, Alejo, Rodríguez-Alonso, Andrés, Useros-Rodríguez, Eduardo, López-Campos, Fernando, Amor-Carro, Oscar, Arribas-Ruiz, Alberto, Martínez-Torres, Javier, Roca-Pardiñas, Javier, Quesada-García, Alba, Muñoz-Del-Toro, Jacobo R., Juárez-Soto, Álvaro
Format: article
Status:Published version
Publication Date:2022
Country:España
Institution:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repository:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10230/53783
Online Access:http://hdl.handle.net/10230/53783
http://dx.doi.org/10.1016/j.clgc.2021.11.008
Access Level:Open access
Keyword:Apalutamide
Darolutamide
Enzalutamide
Next-generation anti-androgens
Survival analysis
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spelling Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysisRodriguez-Vida, AlejoRodríguez-Alonso, AndrésUseros-Rodríguez, EduardoLópez-Campos, FernandoAmor-Carro, OscarArribas-Ruiz, AlbertoMartínez-Torres, JavierRoca-Pardiñas, JavierQuesada-García, AlbaMuñoz-Del-Toro, Jacobo R.Juárez-Soto, ÁlvaroApalutamideDarolutamideEnzalutamideNext-generation anti-androgensSurvival analysisThere was a high medical need for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) when several next-generation anti-androgens (apalutamide, enzalutamide, and darolutamide) demonstrated clinically relevant delays in metastasis onset. However, to date, few publications have assessed the pooled effect of these treatments on overall survival (OS). We performed a systematic review and meta-analysis of all randomized, placebo-controlled studies investigating a systemic treatment in nmCRPC. Publications were identified by searching several databases on April 7, 2021. The primary objective of this analysis was to determine the OS benefit. Secondary outcomes included the relative risk (RR) of adverse events (AEs) and grade 3-4 AEs. A sensitivity analysis with simulated data was also conducted to examine the influence of the study designs on the results. Three randomized controlled studies (SPARTAN, PROSPER, ARAMIS) met our inclusion criteria. Pooled meta-analyses showed a significant benefit in OS with the active agents versus placebo (hazard ratio [HR] 0.74, 95% confidence interval [CI] 0.65-0.83), as well as increased risk of any grade (RR 1.09, 95% CI 1.01-1.17) and grade 3-4 AEs (RR 1.50, 95% CI 1.23-1.83). The sensitivity analysis with SPARTAN-like simulated populations demonstrated that when using ARAMIS statistical design, OS would be statistically significant in 98.1% of the cases, at a shorter follow-up and with lower number of events. First-line treatment of nmCRPC patients with anti-androgens increased OS with an acceptable safety profile. In light of the different study designs and follow-up, results should be interpreted separately.Elsevier202220222022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/53783http://dx.doi.org/10.1016/j.clgc.2021.11.008reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)Inglés© 2021 Rodriguez-Vida A, Rodríguez-Alonso A, Useros-Rodríguez E, Lopez-Campos F, Amor-Carro O, Arribas-Ruiz A. Published by Elsevier Inc. This is an open access article under the CC BY license http://creativecommons.org/licenses/by/4.0/http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:10230/537832026-05-29T05:05:01Z
dc.title.none.fl_str_mv Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis
title Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis
spellingShingle Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis
Rodriguez-Vida, Alejo
Apalutamide
Darolutamide
Enzalutamide
Next-generation anti-androgens
Survival analysis
title_short Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis
title_full Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis
title_fullStr Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis
title_full_unstemmed Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis
title_sort Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis
dc.creator.none.fl_str_mv Rodriguez-Vida, Alejo
Rodríguez-Alonso, Andrés
Useros-Rodríguez, Eduardo
López-Campos, Fernando
Amor-Carro, Oscar
Arribas-Ruiz, Alberto
Martínez-Torres, Javier
Roca-Pardiñas, Javier
Quesada-García, Alba
Muñoz-Del-Toro, Jacobo R.
Juárez-Soto, Álvaro
author Rodriguez-Vida, Alejo
author_facet Rodriguez-Vida, Alejo
Rodríguez-Alonso, Andrés
Useros-Rodríguez, Eduardo
López-Campos, Fernando
Amor-Carro, Oscar
Arribas-Ruiz, Alberto
Martínez-Torres, Javier
Roca-Pardiñas, Javier
Quesada-García, Alba
Muñoz-Del-Toro, Jacobo R.
Juárez-Soto, Álvaro
author_role author
author2 Rodríguez-Alonso, Andrés
Useros-Rodríguez, Eduardo
López-Campos, Fernando
Amor-Carro, Oscar
Arribas-Ruiz, Alberto
Martínez-Torres, Javier
Roca-Pardiñas, Javier
Quesada-García, Alba
Muñoz-Del-Toro, Jacobo R.
Juárez-Soto, Álvaro
author2_role author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Apalutamide
Darolutamide
Enzalutamide
Next-generation anti-androgens
Survival analysis
topic Apalutamide
Darolutamide
Enzalutamide
Next-generation anti-androgens
Survival analysis
description There was a high medical need for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) when several next-generation anti-androgens (apalutamide, enzalutamide, and darolutamide) demonstrated clinically relevant delays in metastasis onset. However, to date, few publications have assessed the pooled effect of these treatments on overall survival (OS). We performed a systematic review and meta-analysis of all randomized, placebo-controlled studies investigating a systemic treatment in nmCRPC. Publications were identified by searching several databases on April 7, 2021. The primary objective of this analysis was to determine the OS benefit. Secondary outcomes included the relative risk (RR) of adverse events (AEs) and grade 3-4 AEs. A sensitivity analysis with simulated data was also conducted to examine the influence of the study designs on the results. Three randomized controlled studies (SPARTAN, PROSPER, ARAMIS) met our inclusion criteria. Pooled meta-analyses showed a significant benefit in OS with the active agents versus placebo (hazard ratio [HR] 0.74, 95% confidence interval [CI] 0.65-0.83), as well as increased risk of any grade (RR 1.09, 95% CI 1.01-1.17) and grade 3-4 AEs (RR 1.50, 95% CI 1.23-1.83). The sensitivity analysis with SPARTAN-like simulated populations demonstrated that when using ARAMIS statistical design, OS would be statistically significant in 98.1% of the cases, at a shorter follow-up and with lower number of events. First-line treatment of nmCRPC patients with anti-androgens increased OS with an acceptable safety profile. In light of the different study designs and follow-up, results should be interpreted separately.
publishDate 2022
dc.date.none.fl_str_mv 2022
2022
2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/53783
http://dx.doi.org/10.1016/j.clgc.2021.11.008
url http://hdl.handle.net/10230/53783
http://dx.doi.org/10.1016/j.clgc.2021.11.008
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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