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dc.contributor.authorSuresh S. Ramalingamen_US
dc.contributor.authorJohan Vansteenkisteen_US
dc.contributor.authorDavid Plancharden_US
dc.contributor.authorByoung Chul Choen_US
dc.contributor.authorJhanelle E. Grayen_US
dc.contributor.authorYuichiro Oheen_US
dc.contributor.authorCaicun Zhouen_US
dc.contributor.authorThanyanan Reungwetwattanaen_US
dc.contributor.authorYing Chengen_US
dc.contributor.authorBusyamas Chewaskulyongen_US
dc.contributor.authorRiyaz Shahen_US
dc.contributor.authorManuel Coboen_US
dc.contributor.authorKi Hyeong Leeen_US
dc.contributor.authorParneet Cheemaen_US
dc.contributor.authorMarcello Tiseoen_US
dc.contributor.authorThomas Johnen_US
dc.contributor.authorMeng Chih Linen_US
dc.contributor.authorFumio Imamuraen_US
dc.contributor.authorTakayasu Kurataen_US
dc.contributor.authorAlexander Todden_US
dc.contributor.authorRachel Hodgeen_US
dc.contributor.authorMatilde Saggeseen_US
dc.contributor.authorYuri Rukazenkoven_US
dc.contributor.authorJean Charles Soriaen_US
dc.contributor.otherYonsei Cancer Centeren_US
dc.contributor.otherJilin Provincial Cancer Hospitalen_US
dc.contributor.otherShanghai Pulmonary Hospitalen_US
dc.contributor.otherChang Gung University College of Medicineen_US
dc.contributor.otherKU Leuven– University Hospital Leuvenen_US
dc.contributor.otherInstitut de Cancerologie Gustave Roussyen_US
dc.contributor.otherKansai Medical Universityen_US
dc.contributor.otherUniversité Paris-Suden_US
dc.contributor.otherNational Cancer Center Hospitalen_US
dc.contributor.otherUniversity of Torontoen_US
dc.contributor.otherFaculty of Medicine, Ramathibodi Hospital, Mahidol Universityen_US
dc.contributor.otherHospital Regional Universitario Carlos Hayaen_US
dc.contributor.otherUniversità degli Studi di Parma, Facoltà di Medicina e Chirurgiaen_US
dc.contributor.otherChungbuk National University, College of Medicineen_US
dc.contributor.otherAustin Healthen_US
dc.contributor.otherMoffitt Cancer Centeren_US
dc.contributor.otherMaidstone Hospitalen_US
dc.contributor.otherEmory University School of Medicineen_US
dc.contributor.otherChiang Mai Universityen_US
dc.contributor.otherOsaka International Cancer Instituteen_US
dc.identifier.citationNew England Journal of Medicine. Vol.382, No.1 (2020), 41-50en_US
dc.description.abstractCopyright © 2019 Massachusetts Medical Society. 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 firstline osimertinib with other EGFR-TKIs in patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). The trial showed longer progressionfree 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 number, NCT02296125.)en_US
dc.rightsMahidol Universityen_US
dc.titleOverall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLCen_US
Appears in Collections:Scopus 2020

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