Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
DC Field | Value | Language |
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dc.contributor.author | Soria, J. -C. | - |
dc.contributor.author | Ohe, Y. | - |
dc.contributor.author | Vansteenkiste, J. | - |
dc.contributor.author | Reungwetwattana, T. | - |
dc.contributor.author | Chewaskulyong, B. | - |
dc.contributor.author | Lee, K. H. | - |
dc.contributor.author | Dechaphunkul, A. | - |
dc.contributor.author | Imamura, F. | - |
dc.contributor.author | Nogami, N. | - |
dc.contributor.author | Kurata, T. | - |
dc.contributor.author | Okamoto, I. | - |
dc.contributor.author | Zhou, C. | - |
dc.contributor.author | Cho, B. C. | - |
dc.contributor.author | Cheng, Y. | - |
dc.contributor.author | Cho, E. K. | - |
dc.contributor.author | Voon, P. J. | - |
dc.contributor.author | Planchard, D. | - |
dc.contributor.author | Su, W. -C. | - |
dc.contributor.author | Gray, J. E. | - |
dc.contributor.author | Lee, S. -M. | - |
dc.contributor.author | Hodge, R. | - |
dc.contributor.author | Marotti, M. | - |
dc.contributor.author | Rukazenkov, Y. | - |
dc.contributor.author | Ramalingam, S. S. | - |
dc.date.available | 2020-02-27T12:41:24Z | - |
dc.date.created | 2020-02-06 | - |
dc.date.issued | 2018-01-11 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/4170 | - |
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. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | MASSACHUSETTS MEDICAL SOC | - |
dc.relation.isPartOf | NEW ENGLAND JOURNAL OF MEDICINE | - |
dc.subject | OPEN-LABEL | - |
dc.subject | ACQUIRED-RESISTANCE | - |
dc.subject | 1ST-LINE TREATMENT | - |
dc.subject | PHASE-III | - |
dc.subject | CNS RESPONSE | - |
dc.subject | AZD9291 | - |
dc.subject | CHEMOTHERAPY | - |
dc.subject | GEFITINIB | - |
dc.subject | ERLOTINIB | - |
dc.subject | THERAPY | - |
dc.title | Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000419971600005 | - |
dc.identifier.doi | 10.1056/NEJMoa1713137 | - |
dc.identifier.bibliographicCitation | NEW ENGLAND JOURNAL OF MEDICINE, v.378, no.2, pp.113 - 125 | - |
dc.citation.endPage | 125 | - |
dc.citation.startPage | 113 | - |
dc.citation.title | NEW ENGLAND JOURNAL OF MEDICINE | - |
dc.citation.volume | 378 | - |
dc.citation.number | 2 | - |
dc.contributor.affiliatedAuthor | Cho, E. K. | - |
dc.type.docType | Article | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | ACQUIRED-RESISTANCE | - |
dc.subject.keywordPlus | 1ST-LINE TREATMENT | - |
dc.subject.keywordPlus | PHASE-III | - |
dc.subject.keywordPlus | CNS RESPONSE | - |
dc.subject.keywordPlus | AZD9291 | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | GEFITINIB | - |
dc.subject.keywordPlus | ERLOTINIB | - |
dc.subject.keywordPlus | THERAPY | - |
dc.relation.journalResearchArea | General & Internal Medicine | - |
dc.relation.journalWebOfScienceCategory | Medicine, General & Internal | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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