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Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2020-02-11T06:58:16Z | - |
dc.date.available | 2020-02-11T06:58:16Z | - |
dc.date.issued | 2020 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/174926 | - |
dc.description.abstract | BACKGROUND: Osimertinib is a third-generation, irreversible tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. A phase 3 trial compared first-line osimertinib with other EGFR-TKIs in patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). The trial showed longer progression-free survival with osimertinib than with the comparator EGFR-TKIs (hazard ratio for disease progression or death, 0.46). Data from the final analysis of overall survival have not been reported. METHODS: In this trial, we randomly assigned 556 patients with previously untreated advanced NSCLC with an EGFR mutation (exon 19 deletion or L858R allele) in a 1:1 ratio to receive either osimertinib (80 mg once daily) or one of two other EGFR-TKIs (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily, with patients receiving these drugs combined in a single comparator group). Overall survival was a secondary end point. RESULTS: The median overall survival was 38.6 months (95% confidence interval [CI], 34.5 to 41.8) in the osimertinib group and 31.8 months (95% CI, 26.6 to 36.0) in the comparator group (hazard ratio for death, 0.80; 95.05% CI, 0.64 to 1.00; P = 0.046). At 3 years, 79 of 279 patients (28%) in the osimertinib group and 26 of 277 (9%) in the comparator group were continuing to receive a trial regimen; the median exposure was 20.7 months and 11.5 months, respectively. Adverse events of grade 3 or higher were reported in 42% of the patients in the osimertinib group and in 47% of those in the comparator group. CONCLUSIONS: Among patients with previously untreated advanced NSCLC with an EGFR mutation, those who received osimertinib had longer overall survival than those who received a comparator EGFR-TKI. The safety profile for osimertinib was similar to that of the comparator EGFR-TKIs, despite a longer duration of exposure in the osimertinib group. (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.title | Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | S.S. Ramalingam | - |
dc.contributor.googleauthor | J. Vansteenkiste | - |
dc.contributor.googleauthor | D. Planchard | - |
dc.contributor.googleauthor | B.C. Cho | - |
dc.contributor.googleauthor | J.E. Gray | - |
dc.contributor.googleauthor | Y. Ohe | - |
dc.contributor.googleauthor | C. Zhou | - |
dc.contributor.googleauthor | T. Reungwetwattana | - |
dc.contributor.googleauthor | Y. Cheng | - |
dc.contributor.googleauthor | B. Chewaskulyong | - |
dc.contributor.googleauthor | R. Shah | - |
dc.contributor.googleauthor | M. Cobo | - |
dc.contributor.googleauthor | K.H. Lee | - |
dc.contributor.googleauthor | P. Cheema | - |
dc.contributor.googleauthor | M. Tiseo | - |
dc.contributor.googleauthor | T. John | - |
dc.contributor.googleauthor | M.-C. Lin | - |
dc.contributor.googleauthor | F. Imamura | - |
dc.contributor.googleauthor | T. Kurata | - |
dc.contributor.googleauthor | A. Todd | - |
dc.contributor.googleauthor | R. Hodge | - |
dc.contributor.googleauthor | M. Saggese | - |
dc.contributor.googleauthor | Y. Rukazenkov | - |
dc.contributor.googleauthor | and J.-C. Soria | - |
dc.contributor.googleauthor | the FLAURA Investigators | - |
dc.identifier.doi | 10.1056/NEJMoa1913662 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J02371 | - |
dc.identifier.eissn | 1533-4406 | - |
dc.identifier.pmid | 31751012 | - |
dc.identifier.url | https://www.nejm.org/doi/full/10.1056/NEJMoa1913662 | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 382 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 41 | - |
dc.citation.endPage | 50 | - |
dc.identifier.bibliographicCitation | NEW ENGLAND JOURNAL OF MEDICINE, Vol.382(1) : 41-50, 2020 | - |
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