Cited 3254 times in
Osimertinib in Untreated EGFR-Mutated Advanced Non–Small-Cell Lung Cancer
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2019-03-15T02:41:22Z | - |
dc.date.available | 2019-03-15T02:41:22Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/167634 | - |
dc.description.abstract | BACKGROUND: 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.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isPartOf | NEW ENGLAND JOURNAL OF MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Aged, 80 and over | - |
dc.subject.MESH | Antineoplastic Agents/adverse effects | - |
dc.subject.MESH | Antineoplastic Agents/therapeutic use* | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung/drug therapy* | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung/genetics | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung/mortality | - |
dc.subject.MESH | Disease-Free Survival | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | ErbB Receptors/genetics* | - |
dc.subject.MESH | Erlotinib Hydrochloride/therapeutic use | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Gefitinib | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Kaplan-Meier Estimate | - |
dc.subject.MESH | Lung Neoplasms/drug therapy* | - |
dc.subject.MESH | Lung Neoplasms/genetics | - |
dc.subject.MESH | Lung Neoplasms/mortality | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Mutation* | - |
dc.subject.MESH | Piperazines/adverse effects | - |
dc.subject.MESH | Piperazines/therapeutic use* | - |
dc.subject.MESH | Protein Kinase Inhibitors/adverse effects | - |
dc.subject.MESH | Protein Kinase Inhibitors/therapeutic use* | - |
dc.subject.MESH | Protein-Tyrosine Kinases/antagonists & inhibitors | - |
dc.subject.MESH | Quinazolines/therapeutic use | - |
dc.subject.MESH | Survival Rate | - |
dc.title | Osimertinib in Untreated EGFR-Mutated Advanced Non–Small-Cell Lung Cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Jean-Charles Soria | - |
dc.contributor.googleauthor | Yuichiro Ohe | - |
dc.contributor.googleauthor | Johan Vansteenkiste | - |
dc.contributor.googleauthor | Thanyanan Reungwetwattana | - |
dc.contributor.googleauthor | Busyamas Chewaskulyong | - |
dc.contributor.googleauthor | Ki Hyeong Lee | - |
dc.contributor.googleauthor | Arunee Dechaphunkul | - |
dc.contributor.googleauthor | Fumio Imamura | - |
dc.contributor.googleauthor | Naoyuki Nogami | - |
dc.contributor.googleauthor | Takayasu Kurata | - |
dc.contributor.googleauthor | Isamu Okamoto | - |
dc.contributor.googleauthor | Caicun Zhou | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Ying Cheng | - |
dc.contributor.googleauthor | Eun Kyung Cho | - |
dc.contributor.googleauthor | Pei Jye Voon | - |
dc.contributor.googleauthor | David Planchard | - |
dc.contributor.googleauthor | Wu-Chou Su | - |
dc.contributor.googleauthor | Jhanelle E. Gray | - |
dc.contributor.googleauthor | Siow-Ming Lee | - |
dc.contributor.googleauthor | Rachel Hodge | - |
dc.contributor.googleauthor | Marcelo Marotti | - |
dc.contributor.googleauthor | Yuri Rukazenkov | - |
dc.contributor.googleauthor | Suresh S. Ramalingam | - |
dc.contributor.googleauthor | FLAURA Investigators | - |
dc.identifier.doi | 10.1056/NEJMoa1713137 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J02371 | - |
dc.identifier.eissn | 1533-4406 | - |
dc.identifier.pmid | 29151359 | - |
dc.identifier.url | https://www.nejm.org/doi/10.1056/NEJMoa1713137 | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 378 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 113 | - |
dc.citation.endPage | 125 | - |
dc.identifier.bibliographicCitation | NEW ENGLAND JOURNAL OF MEDICINE, Vol.378(2) : 113-125, 2018 | - |
dc.identifier.rimsid | 61053 | - |
dc.type.rims | ART | - |
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