RT Journal Article
T1 Impact of New Systemic Therapies in Overall Survival in Non-Metastatic Castration Resistant Prostate Cancer: Systematic Review and Meta-Analysis.
A1 Rodriguez-Vida, Alejo
A1 Rodríguez-Alonso, Andrés
A1 Useros-Rodríguez, Eduardo
A1 Lopez-Campos, Fernando
A1 Amor-Carro, Oscar
A1 Arribas-Ruiz, Alberto
A1 Martinez-Torres, Javier
A1 Roca-Pardiñas, Javier
A1 Quesada-García, Alba
A1 Muñoz-Del-Toro, Jacobo R
A1 Juárez-Soto, Álvaro
K1 Apalutamide
K1 Darolutamide
K1 Enzalutamide
K1 Next-generation anti-androgens
K1 Survival analysis
AB 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.
YR 2021
FD 2021-11-21
LK http://hdl.handle.net/10668/22103
UL http://hdl.handle.net/10668/22103
LA en
DS RISalud
RD Apr 17, 2025