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Title: Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer.
Authors: Smith, Matthew R
Saad, Fred
Chowdhury, Simon
Oudard, Stéphane
Hadaschik, Boris A
Graff, Julie N
Olmos, David
Mainwaring, Paul N
Lee, Ji Youl
Uemura, Hiroji
Lopez-Gitlitz, Angela
Trudel, Géralyn C
Espina, Byron M
Shu, Youyi
Park, Youn C
Rackoff, Wayne R
Yu, Margaret K
Small, Eric J
SPARTAN Investigators
metadata.dc.subject.mesh: Adenocarcinoma
Aged, 80 and over
Androgen Antagonists
Disease Progression
Disease-Free Survival
Double-Blind Method
Middle Aged
Neoplasm Metastasis
Proportional Hazards Models
Prostate-Specific Antigen
Prostatic Neoplasms, Castration-Resistant
Issue Date: 8-Feb-2018
Abstract: Apalutamide, a competitive inhibitor of the androgen receptor, is under development for the treatment of prostate cancer. We evaluated the efficacy of apalutamide in men with nonmetastatic castration-resistant prostate cancer who were at high risk for the development of metastasis. We conducted a double-blind, placebo-controlled, phase 3 trial involving men with nonmetastatic castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less. Patients were randomly assigned, in a 2:1 ratio, to receive apalutamide (240 mg per day) or placebo. All the patients continued to receive androgen-deprivation therapy. The primary end point was metastasis-free survival, which was defined as the time from randomization to the first detection of distant metastasis on imaging or death. A total of 1207 men underwent randomization (806 to the apalutamide group and 401 to the placebo group). In the planned primary analysis, which was performed after 378 events had occurred, median metastasis-free survival was 40.5 months in the apalutamide group as compared with 16.2 months in the placebo group (hazard ratio for metastasis or death, 0.28; 95% confidence interval [CI], 0.23 to 0.35; P Among men with nonmetastatic castration-resistant prostate cancer, metastasis-free survival and time to symptomatic progression were significantly longer with apalutamide than with placebo. (Funded by Janssen Research and Development; SPARTAN number, NCT01946204 .).
metadata.dc.identifier.doi: 10.1056/NEJMoa1715546
Appears in Collections:Producción 2020

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