Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis
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- dc.contributor.author Rodriguez-Vida, Alejo
- dc.contributor.author Rodríguez-Alonso, Andrés
- dc.contributor.author Useros-Rodríguez, Eduardo
- dc.contributor.author Lopez-Campos, Fernando
- dc.contributor.author Amor-Carro, Oscar
- dc.contributor.author Arribas-Ruiz, Alberto
- dc.contributor.author Martínez-Torres, Javier
- dc.contributor.author Roca-Pardiñas, Javier
- dc.contributor.author Quesada-García, Alba
- dc.contributor.author Muñoz-Del-Toro, Jacobo R.
- dc.contributor.author Juárez-Soto, Álvaro
- dc.date.accessioned 2022-07-22T06:32:04Z
- dc.date.available 2022-07-22T06:32:04Z
- dc.date.issued 2022
- dc.description.abstract 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.
- dc.format.mimetype application/pdf
- dc.identifier.citation Rodriguez-Vida A, Rodríguez-Alonso A, Useros-Rodríguez E, Lopez-Campos F, Amor-Carro O, Arribas-Ruiz A, et al. Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis. Clin Genitourin Cancer. 2022 Apr; 20(2): 197.e1-10. DOI: 10.1016/j.clgc.2021.11.008
- dc.identifier.doi http://dx.doi.org/10.1016/j.clgc.2021.11.008
- dc.identifier.issn 1558-7673
- dc.identifier.uri http://hdl.handle.net/10230/53783
- dc.language.iso eng
- dc.publisher Elsevier
- dc.rights © 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/
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri http://creativecommons.org/licenses/by/4.0/
- dc.subject.keyword Apalutamide
- dc.subject.keyword Darolutamide
- dc.subject.keyword Enzalutamide
- dc.subject.keyword Next-generation anti-androgens
- dc.subject.keyword Survival analysis
- dc.title Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/publishedVersion