Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer

Detalhes bibliográficos
Autor(a) principal: Soria, JC
Data de Publicação: 2018
Outros Autores: Ohe, Y, Vansteenkiste, J, Reungwetwattana, T, Chewaskulyong, B, Lee, KH, Almeida, A, et al., FLAURA Investigators
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10400.10/2348
Resumo: FLAURA ClinicalTrials.gov number, NCT02296125
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spelling Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung CancerNon-small cell lung cancerLung neoplasmsAntineoplastic agentsOsimertinibFLAURA ClinicalTrials.gov number, NCT02296125BACKGROUND: Osimertinib is an oral, third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. We compared osimertinib with standard EGFR-TKIs in patients with previously untreated, EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). METHODS: In this double-blind, phase 3 trial, we randomly assigned 556 patients with previously untreated, EGFR mutation-positive (exon 19 deletion or L858R) advanced NSCLC in a 1:1 ratio to receive either osimertinib (at a dose of 80 mg once daily) or a standard EGFR-TKI (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily). The primary end point was investigator-assessed progression-free survival. RESULTS: The median progression-free survival was significantly longer with osimertinib than with standard EGFR-TKIs (18.9 months vs. 10.2 months; hazard ratio for disease progression or death, 0.46; 95% confidence interval [CI], 0.37 to 0.57; P<0.001). The objective response rate was similar in the two groups: 80% with osimertinib and 76% with standard EGFR-TKIs (odds ratio, 1.27; 95% CI, 0.85 to 1.90; P=0.24). The median duration of response was 17.2 months (95% CI, 13.8 to 22.0) with osimertinib versus 8.5 months (95% CI, 7.3 to 9.8) with standard EGFR-TKIs. Data on overall survival were immature at the interim analysis (25% maturity). The survival rate at 18 months was 83% (95% CI, 78 to 87) with osimertinib and 71% (95% CI, 65 to 76) with standard EGFR-TKIs (hazard ratio for death, 0.63; 95% CI, 0.45 to 0.88; P=0.007 [nonsignificant in the interim analysis]). Adverse events of grade 3 or higher were less frequent with osimertinib than with standard EGFR-TKIs (34% vs. 45%). CONCLUSIONS: Osimertinib showed efficacy superior to that of standard EGFR-TKIs in the first-line treatment of EGFR mutation-positive advanced NSCLC, with a similar safety profile and lower rates of serious adverse events. (Funded by AstraZeneca; FLAURA ClinicalTrials.gov number, NCT02296125 .).Massachusetts Medical SocietyRepositório do Hospital Prof. Doutor Fernando FonsecaSoria, JCOhe, YVansteenkiste, JReungwetwattana, TChewaskulyong, BLee, KHAlmeida, A, et al.FLAURA Investigators2019-12-16T11:23:51Z2018-01-01T00:00:00Z2018-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.10/2348engN Engl J Med. 2018 Jan 11;378(2):113-125.1533-440610.1056/NEJMoa1713137info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2022-09-20T15:53:02Zoai:repositorio.hff.min-saude.pt:10400.10/2348Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T15:53:17.605840Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
title Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
spellingShingle Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
Soria, JC
Non-small cell lung cancer
Lung neoplasms
Antineoplastic agents
Osimertinib
title_short Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
title_full Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
title_fullStr Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
title_full_unstemmed Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
title_sort Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
author Soria, JC
author_facet Soria, JC
Ohe, Y
Vansteenkiste, J
Reungwetwattana, T
Chewaskulyong, B
Lee, KH
Almeida, A, et al.
FLAURA Investigators
author_role author
author2 Ohe, Y
Vansteenkiste, J
Reungwetwattana, T
Chewaskulyong, B
Lee, KH
Almeida, A, et al.
FLAURA Investigators
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Repositório do Hospital Prof. Doutor Fernando Fonseca
dc.contributor.author.fl_str_mv Soria, JC
Ohe, Y
Vansteenkiste, J
Reungwetwattana, T
Chewaskulyong, B
Lee, KH
Almeida, A, et al.
FLAURA Investigators
dc.subject.por.fl_str_mv Non-small cell lung cancer
Lung neoplasms
Antineoplastic agents
Osimertinib
topic Non-small cell lung cancer
Lung neoplasms
Antineoplastic agents
Osimertinib
description FLAURA ClinicalTrials.gov number, NCT02296125
publishDate 2018
dc.date.none.fl_str_mv 2018-01-01T00:00:00Z
2018-01-01T00:00:00Z
2019-12-16T11:23:51Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10400.10/2348
url http://hdl.handle.net/10400.10/2348
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv N Engl J Med. 2018 Jan 11;378(2):113-125.
1533-4406
10.1056/NEJMoa1713137
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Massachusetts Medical Society
publisher.none.fl_str_mv Massachusetts Medical Society
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
repository.mail.fl_str_mv
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