Publication
Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
| dc.contributor.author | Soria, JC | |
| dc.contributor.author | Ohe, Y | |
| dc.contributor.author | Vansteenkiste, J | |
| dc.contributor.author | Reungwetwattana, T | |
| dc.contributor.author | Chewaskulyong, B | |
| dc.contributor.author | Lee, KH | |
| dc.contributor.author | Almeida, A, et al. | |
| dc.contributor.author | FLAURA Investigators | |
| dc.date.accessioned | 2019-12-16T11:23:51Z | |
| dc.date.available | 2019-12-16T11:23:51Z | |
| dc.date.issued | 2018 | |
| dc.description | FLAURA ClinicalTrials.gov number, NCT02296125 | pt_PT |
| 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 .). | pt_PT |
| dc.description.version | info:eu-repo/semantics/publishedVersion | pt_PT |
| dc.identifier.citation | N Engl J Med. 2018 Jan 11;378(2):113-125. | pt_PT |
| dc.identifier.doi | 10.1056/NEJMoa1713137 | pt_PT |
| dc.identifier.issn | 1533-4406 | |
| dc.identifier.uri | http://hdl.handle.net/10400.10/2348 | |
| dc.language.iso | eng | pt_PT |
| dc.peerreviewed | yes | pt_PT |
| dc.publisher | Massachusetts Medical Society | pt_PT |
| dc.relation.publisherversion | https://www.nejm.org/doi/pdf/10.1056/NEJMoa1713137?articleTools=true | pt_PT |
| dc.subject | Non-small cell lung cancer | pt_PT |
| dc.subject | Lung neoplasms | pt_PT |
| dc.subject | Antineoplastic agents | pt_PT |
| dc.subject | Osimertinib | pt_PT |
| dc.title | Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer | pt_PT |
| dc.type | journal article | |
| dspace.entity.type | Publication | |
| oaire.citation.conferencePlace | Boston | pt_PT |
| oaire.citation.title | New England Journal of Medicine | pt_PT |
| rcaap.rights | openAccess | pt_PT |
| rcaap.type | article | pt_PT |