Perioperative Apalutamide in High-Risk Localized Prostate Cancer (Registro nro. 22813)

000 -Cabecera
Campo de control interno 03511nam a2200289 4500
001 - Número de control
control field ESSALUD
007 - Tipo material - Descripcion fisica - info general
Tipo material - Descripcion fisica - info general ta
008 - Elementos de Longitud Fija - Información General
Elementos de Longitud Fija - Información t pe ||||| |||| 00| 0 spa d
040 ## - Origen de la Catalogación
Origen de la Catalogación BMG
041 ## - Idioma
Idioma eng
100 ## - Autor
Autor Taplin, Mary-Ellen
Rol del Autor Autor
9 (RLIN) 54053
245 ## - Titulo
Titulo Perioperative Apalutamide in High-Risk Localized Prostate Cancer
300 ## - Páginas
Paginación páginas: 546-560
520 ## - Resumen
Resumen Background: Radical prostatectomy is potentially curative in patients with high-risk localized or locally advanced prostate cancer; however, relapse occurs within 5 years in up to 50% of patients. Methods: We conducted a phase 3, double-blind, placebo-controlled trial in which patients with newly diagnosed high-risk localized or locally advanced prostate cancer were randomly assigned in a 1:1 ratio to receive androgen-deprivation therapy (ADT) plus apalutamide (240 mg per day) or ADT plus placebo for 6 cycles (28 days each) before and after radical prostatectomy with pelvic lymph-node dissection. The dual primary end points were a composite of pathological complete response or minimal residual disease (defined as a pathological stage of ypT2 or lower, with a tumor size of ≤5 mm in the greatest dimension) and metastasis-free survival, as assessed with conventional imaging or prostate-specific membrane antigen positron-emission tomography. Secondary end points included event-free survival, first subsequent treatment, and distant metastasis (assessed in time-to-event analyses), as well as safety. Results: A total of 2109 patients underwent randomization: 1057 were assigned to receive ADT plus apalutamide, and 1052 to receive ADT plus placebo. The median follow-up was 61.7 months. The percentage of patients with a pathological complete response or minimal residual disease was significantly higher in the apalutamide group than in the placebo group (8.9% vs. 1.0%; odds ratio, 10.17; 95% confidence interval [CI], 5.27 to 19.64; P<0.001), as was the percentage of patients with metastasis-free survival (probability of metastasis-free survival at 5 years, 78.2% vs. 73.5%; hazard ratio for distant metastasis or death, 0.80; 95% CI, 0.67 to 0.96; P=0.02). Event-free survival, time to the first subsequent treatment, and time to distant metastasis significantly favored ADT plus apalutamide over ADT plus placebo (P<0.001 for all between-group comparisons). Grade 3 or 4 adverse events occurred in 39.6% of the patients in the apalutamide group and in 31.0% of those in the placebo group, with the difference between the groups driven primarily by a higher incidence of rash in the apalutamide group. Conclusions: Perioperative treatment with ADT plus apalutamide was associated with better oncologic outcomes of radical prostatectomy in patients with high-risk localized or locally advanced prostate cancer than treatment with ADT plus placebo. Adverse events were more common in the apalutamide group than in the placebo group.
650 ## - Temas - Descriptores
Temas - Descriptores CÁNCER GENITOURINARIO
9 (RLIN) 53654
650 ## - Temas - Descriptores
Temas - Descriptores TRATAMIENTOS EN ONCOLOGÍA
9 (RLIN) 53734
650 ## - Temas - Descriptores
Temas - Descriptores UROLOGÍA
9 (RLIN) 6502
650 ## - Temas - Descriptores
Temas - Descriptores ENFERMEDADES DE LA PRÓSTATA
9 (RLIN) 53783
700 ## - Autor Personal
Autor Personal Gleave, Martin
9 (RLIN) 54054
700 ## - Autor Personal
Autor Personal Shore, Neal D.
9 (RLIN) 54055
700 ## - Autor Personal
Autor Personal Lopez-Gitlitz, Angela
9 (RLIN) 54056
700 ## - Autor Personal
Autor Personal Kretschmer, Alexander
9 (RLIN) 54057
700 ## - Autor Personal
Autor Personal Efstathiou, Eleni
9 (RLIN) 54058
700 ## - Autor Personal
Autor Personal Nguyen, Paul L.
9 (RLIN) 54059
773 0# - Revista (Relacion con el numero)
Host Biblionumber 22717
Host Itemnumber 22644
Ciudad, Editorial Massachusetts NEJM Group
Codigo barras item/ejemplar NEJM009
Titulo de la Revista The New England Journal of Medicine
Número de control de registro ESSALUD
ISSN 0028-4793
942 ## - Elementos de Koha
Tipo de Documento Artículos
Fecha procesamiento 2026-08-14
Catalogador SQB

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