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http://hdl.handle.net/2445/172442
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DC Field | Value | Language |
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dc.contributor.author | Armstrong, Andrew J. | - |
dc.contributor.author | Szmulewitz, Russell Z. | - |
dc.contributor.author | Petrylak, Daniel P. | - |
dc.contributor.author | Holzbeierlein, Jeffrey | - |
dc.contributor.author | Villers, Arnauld | - |
dc.contributor.author | Azad, Arun | - |
dc.contributor.author | Alcaraz Asensio, Antonio | - |
dc.contributor.author | Alekseev, Boris | - |
dc.contributor.author | Iguchi, Taro | - |
dc.contributor.author | Shore, Neal D. | - |
dc.contributor.author | Rosbrook, Brad | - |
dc.contributor.author | Sugg, Jennifer | - |
dc.contributor.author | Baron, Benoit | - |
dc.contributor.author | Chen, Lucy | - |
dc.contributor.author | Stenzl, Arnulf | - |
dc.date.accessioned | 2020-11-30T14:11:41Z | - |
dc.date.available | 2020-11-30T14:11:41Z | - |
dc.date.issued | 2019-11-10 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | http://hdl.handle.net/2445/172442 | - |
dc.description.abstract | PURPOSE: Enzalutamide, a potent androgen-receptor inhibitor, has demonstrated significant benefits in metastatic and nonmetastatic castration-resistant prostate cancer. We evaluated the efficacy and safety of enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC). METHODS: ARCHES (ClinicalTrials.gov identifier: NCT02677896) is a multinational, double-blind, phase III trial, wherein 1,150 men with mHSPC were randomly assigned 1:1 to enzalutamide (160 mg/day) or placebo, plus androgen deprivation therapy (ADT), stratified by disease volume and prior docetaxel chemotherapy. The primary end point was radiographic progression-free survival. RESULTS: As of October 14, 2018, the risk of radiographic progression or death was significantly reduced with enzalutamide plus ADT versus placebo plus ADT (hazard ratio, 0.39; 95% CI, 0.30 to 0.50; P < .001; median not reached v 19.0 months). Similar significant improvements in radiographic progression-free survival were reported in prespecified subgroups on the basis of disease volume and prior docetaxel therapy. Enzalutamide plus ADT significantly reduced the risk of prostate-specific antigen progression, initiation of new antineoplastic therapy, first symptomatic skeletal event, castration resistance, and reduced risk of pain progression. More men achieved an undetectable prostate-specific antigen level and/or an objective response with enzalutamide plus ADT (P < .001). Patients in both treatment groups reported a high baseline level of quality of life, which was maintained over time. Grade 3 or greater adverse events were reported in 24.3% of patients who received enzalutamide plus ADT versus 25.6% of patients who received placebo plus ADT, with no unexpected adverse events. CONCLUSION: Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC, including those with low-volume disease and/or prior docetaxel, with a safety analysis that seems consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer. | - |
dc.format.extent | 13 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1200/JCO.19.00799 | - |
dc.relation.ispartof | Journal of Clinical Oncology, 2019, vol. 37, num. 32, p. 2974-2986 | - |
dc.relation.uri | https://doi.org/10.1200/JCO.19.00799 | - |
dc.rights | cc-by (c) Armstrong, et. al., 2019 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es/ | * |
dc.source | Articles publicats en revistes (Cirurgia i Especialitats Medicoquirúrgiques) | - |
dc.subject.classification | Càncer de pròstata | - |
dc.subject.classification | Quimioteràpia del càncer | - |
dc.subject.classification | Antígens | - |
dc.subject.other | Prostate cancer | - |
dc.subject.other | Cancer chemotherapy | - |
dc.subject.other | Antigens | - |
dc.title | ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 701903 | - |
dc.date.updated | 2020-11-30T11:34:41Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 31329516 | - |
Appears in Collections: | Articles publicats en revistes (Cirurgia i Especialitats Medicoquirúrgiques) |
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