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

DC Field Value Language
dc.contributor.author조병철-
dc.date.accessioned2019-03-15T02:41:22Z-
dc.date.available2019-03-15T02:41:22Z-
dc.date.issued2018-
dc.identifier.issn0028-4793-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/167634-
dc.description.abstractBACKGROUND: 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 .).-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherMassachusetts Medical Society-
dc.relation.isPartOfNEW ENGLAND JOURNAL OF MEDICINE-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHAntineoplastic Agents/adverse effects-
dc.subject.MESHAntineoplastic Agents/therapeutic use*-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung/drug therapy*-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung/genetics-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung/mortality-
dc.subject.MESHDisease-Free Survival-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHErbB Receptors/genetics*-
dc.subject.MESHErlotinib Hydrochloride/therapeutic use-
dc.subject.MESHFemale-
dc.subject.MESHGefitinib-
dc.subject.MESHHumans-
dc.subject.MESHKaplan-Meier Estimate-
dc.subject.MESHLung Neoplasms/drug therapy*-
dc.subject.MESHLung Neoplasms/genetics-
dc.subject.MESHLung Neoplasms/mortality-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHMutation*-
dc.subject.MESHPiperazines/adverse effects-
dc.subject.MESHPiperazines/therapeutic use*-
dc.subject.MESHProtein Kinase Inhibitors/adverse effects-
dc.subject.MESHProtein Kinase Inhibitors/therapeutic use*-
dc.subject.MESHProtein-Tyrosine Kinases/antagonists & inhibitors-
dc.subject.MESHQuinazolines/therapeutic use-
dc.subject.MESHSurvival Rate-
dc.titleOsimertinib in Untreated EGFR-Mutated Advanced Non–Small-Cell Lung Cancer-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorJean-Charles Soria-
dc.contributor.googleauthorYuichiro Ohe-
dc.contributor.googleauthorJohan Vansteenkiste-
dc.contributor.googleauthorThanyanan Reungwetwattana-
dc.contributor.googleauthorBusyamas Chewaskulyong-
dc.contributor.googleauthorKi Hyeong Lee-
dc.contributor.googleauthorArunee Dechaphunkul-
dc.contributor.googleauthorFumio Imamura-
dc.contributor.googleauthorNaoyuki Nogami-
dc.contributor.googleauthorTakayasu Kurata-
dc.contributor.googleauthorIsamu Okamoto-
dc.contributor.googleauthorCaicun Zhou-
dc.contributor.googleauthorByoung Chul Cho-
dc.contributor.googleauthorYing Cheng-
dc.contributor.googleauthorEun Kyung Cho-
dc.contributor.googleauthorPei Jye Voon-
dc.contributor.googleauthorDavid Planchard-
dc.contributor.googleauthorWu-Chou Su-
dc.contributor.googleauthorJhanelle E. Gray-
dc.contributor.googleauthorSiow-Ming Lee-
dc.contributor.googleauthorRachel Hodge-
dc.contributor.googleauthorMarcelo Marotti-
dc.contributor.googleauthorYuri Rukazenkov-
dc.contributor.googleauthorSuresh S. Ramalingam-
dc.contributor.googleauthorFLAURA Investigators-
dc.identifier.doi10.1056/NEJMoa1713137-
dc.contributor.localIdA03822-
dc.relation.journalcodeJ02371-
dc.identifier.eissn1533-4406-
dc.identifier.pmid29151359-
dc.identifier.urlhttps://www.nejm.org/doi/10.1056/NEJMoa1713137-
dc.contributor.alternativeNameCho, Byoung Chul-
dc.contributor.affiliatedAuthor조병철-
dc.citation.volume378-
dc.citation.number2-
dc.citation.startPage113-
dc.citation.endPage125-
dc.identifier.bibliographicCitationNEW ENGLAND JOURNAL OF MEDICINE, Vol.378(2) : 113-125, 2018-
dc.identifier.rimsid61053-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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