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Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC

Authors
 S.S. Ramalingam  ;  J. Vansteenkiste  ;  D. Planchard  ;  B.C. Cho  ;  J.E. Gray  ;  Y. Ohe  ;  C. Zhou  ;  T. Reungwetwattana  ;  Y. Cheng  ;  B. Chewaskulyong  ;  R. Shah  ;  M. Cobo  ;  K.H. Lee  ;  P. Cheema  ;  M. Tiseo  ;  T. John  ;  M.-C. Lin  ;  F. Imamura  ;  T. Kurata  ;  A. Todd  ;  R. Hodge  ;  M. Saggese  ;  Y. Rukazenkov  ;  and J.-C. Soria  ;  the FLAURA Investigators 
Citation
 NEW ENGLAND JOURNAL OF MEDICINE, Vol.382(1) : 41-50, 2020 
Journal Title
 NEW ENGLAND JOURNAL OF MEDICINE 
ISSN
 0028-4793 
Issue Date
2020
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.).
Full Text
https://www.nejm.org/doi/full/10.1056/NEJMoa1913662
DOI
10.1056/NEJMoa1913662
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/174926
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