RT Journal Article
T1 Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study.
A1 Chi, Kim N
A1 Chowdhury, Simon
A1 Bjartell, Anders
A1 Chung, Byung Ha
A1 Pereira de Santana Gomes, Andrea J
A1 Given, Robert
A1 Juárez, Alvaro
A1 Merseburger, Axel S
A1 Özgüroğlu, Mustafa
A1 Uemura, Hirotsugu
A1 Ye, Dingwei
A1 Brookman-May, Sabine
A1 Mundle, Suneel D
A1 McCarthy, Sharon A
A1 Larsen, Julie S
A1 Sun, Weili
A1 Bevans, Katherine B
A1 Zhang, Ke
A1 Bandyopadhyay, Nibedita
A1 Agarwal, Neeraj
AB The first interim analysis of the phase III, randomized, placebo-controlled TITAN study showed that apalutamide significantly improved overall survival (OS) and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) receiving ongoing androgen deprivation therapy (ADT). Herein, we report final efficacy and safety results after unblinding and placebo-to-apalutamide crossover. Patients with mCSPC (N = 1,052) were randomly assigned 1:1 to receive apalutamide (240 mg QD) or placebo plus ADT. After unblinding in January 2019, placebo-treated patients were allowed to receive apalutamide. Efficacy end points were updated using the Kaplan-Meier method and Cox proportional-hazards model without formal statistical retesting and adjustment for multiplicity. Change from baseline in Functional Assessment of Cancer Therapy-Prostate total score was assessed. With a median follow-up of 44.0 months, 405 OS events had occurred and 208 placebo-treated patients (39.5%) had crossed over to apalutamide. The median treatment duration was 39.3 (apalutamide), 20.2 (placebo), and 15.4 months (crossover). Compared with placebo, apalutamide plus ADT significantly reduced the risk of death by 35% (median OS not reached v 52.2 months; hazard ratio, 0.65; 95% CI, 0.53 to 0.79; P  The final analysis of TITAN confirmed that, despite crossover, apalutamide plus ADT improved OS, delayed castration resistance, maintained health-related quality of life, and had a consistent safety profile in a broad population of patients with mCSPC.
YR 2021
FD 2021-04-29
LK https://hdl.handle.net/10668/25057
UL https://hdl.handle.net/10668/25057
LA en
DS RISalud
RD Apr 6, 2025