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Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer
DC Field | Value | Language |
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dc.contributor.author | 김혜련 | - |
dc.date.accessioned | 2018-07-20T07:47:27Z | - |
dc.date.available | 2018-07-20T07:47:27Z | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/160525 | - |
dc.description.abstract | BACKGROUND: Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer. The efficacy of osimertinib as compared with platinum-based therapy plus pemetrexed in such patients is unknown. METHODS: In this randomized, international, open-label, phase 3 trial, we assigned 419 patients with T790M-positive advanced non-small-cell lung cancer, who had disease progression after first-line EGFR-TKI therapy, in a 2:1 ratio to receive either oral osimertinib (at a dose of 80 mg once daily) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles; maintenance pemetrexed was allowed. In all the patients, disease had progressed during receipt of first-line EGFR-TKI therapy. The primary end point was investigator-assessed progression-free survival. RESULTS: The median duration of progression-free survival was significantly longer with osimertinib than with platinum therapy plus pemetrexed (10.1 months vs. 4.4 months; hazard ratio; 0.30; 95% confidence interval [CI], 0.23 to 0.41; P<0.001). The objective response rate was significantly better with osimertinib (71%; 95% CI, 65 to 76) than with platinum therapy plus pemetrexed (31%; 95% CI, 24 to 40) (odds ratio for objective response, 5.39; 95% CI, 3.47 to 8.48; P<0.001). Among 144 patients with metastases to the central nervous system (CNS), the median duration of progression-free survival was longer among patients receiving osimertinib than among those receiving platinum therapy plus pemetrexed (8.5 months vs. 4.2 months; hazard ratio, 0.32; 95% CI, 0.21 to 0.49). The proportion of patients with adverse events of grade 3 or higher was lower with osimertinib (23%) than with platinum therapy plus pemetrexed (47%). CONCLUSIONS: Osimertinib had significantly greater efficacy than platinum therapy plus pemetrexed in patients with T790M-positive advanced non-small-cell lung cancer (including those with CNS metastases) in whom disease had progressed during first-line EGFR-TKI therapy. (Funded by AstraZeneca; AURA3 ClinicalTrials.gov number, NCT02151981 .). | - |
dc.description.statementOfResponsibility | open | - |
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 Combined Chemotherapy Protocols/adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/therapeutic use | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung/drug therapy | - |
dc.subject.MESH | Disease-Free Survival | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lung Neoplasms/drug therapy | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Mutation | - |
dc.subject.MESH | Pemetrexed/administration & dosage | - |
dc.subject.MESH | Pemetrexed/adverse effects | - |
dc.subject.MESH | Piperazines/administration & dosage | - |
dc.subject.MESH | Piperazines/adverse effects | - |
dc.subject.MESH | Platinum/administration & dosage | - |
dc.subject.MESH | Receptor, Epidermal Growth Factor/antagonists & inhibitors | - |
dc.subject.MESH | Young Adult | - |
dc.title | Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | T.S. Mok | - |
dc.contributor.googleauthor | Y.-L. Wu | - |
dc.contributor.googleauthor | M.-J. Ahn | - |
dc.contributor.googleauthor | M.C. Garassino | - |
dc.contributor.googleauthor | H.R. Kim | - |
dc.contributor.googleauthor | S.S. Ramalingam | - |
dc.contributor.googleauthor | F.A. Shepherd | - |
dc.contributor.googleauthor | Y. He | - |
dc.contributor.googleauthor | H. Akamatsu | - |
dc.contributor.googleauthor | W.S.M.E. Theelen | - |
dc.contributor.googleauthor | C.K. Lee | - |
dc.contributor.googleauthor | M. Sebastian | - |
dc.contributor.googleauthor | A. Templeton | - |
dc.contributor.googleauthor | H. Mann, M. | - |
dc.contributor.googleauthor | Marotti, S. Ghiorghiu | - |
dc.contributor.googleauthor | V.A. Papadimitrakopoulou | - |
dc.identifier.doi | 10.1056/NEJMoa1612674 | - |
dc.contributor.localId | A01166 | - |
dc.relation.journalcode | J02371 | - |
dc.identifier.eissn | 1533-4406 | - |
dc.identifier.pmid | 27959700 | - |
dc.contributor.alternativeName | Kim, Hye Ryun | - |
dc.contributor.affiliatedAuthor | Kim, Hye Ryun | - |
dc.citation.volume | 376 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 629 | - |
dc.citation.endPage | 640 | - |
dc.identifier.bibliographicCitation | NEW ENGLAND JOURNAL OF MEDICINE, Vol.376(7) : 629-640, 2017 | - |
dc.identifier.rimsid | 44259 | - |
dc.type.rims | ART | - |
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