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In FLAURA's global study, in patients with EGFR mutation-positive (EGFRm) advanced non-small cell lung cancer (NSCLC), third-generation EGFR-TKI osimertinib significantly improved patient survival compared with first-generation EGFR TKIs Progression survival (PFS) and overall survival (OS)
.
Therefore, the domestic team carried out the FLAURA China study, mainly to evaluate the efficacy of osimertinib compared with the first-generation EGFR-TKIs in the first-line treatment of EGFRm NSCLC patients in the Chinese population
In FLAURA's global study, in patients with EGFR mutation-positive (EGFRm) advanced non-small cell lung cancer (NSCLC), third-generation EGFR-TKI osimertinib significantly improved patient survival compared with first-generation EGFR TKIs Progression survival (PFS) and overall survival (OS)
The FLAURA China study is a double-blind, randomized, phase III study of previously untreated EGFRm (exon 19 deletion or L858R) advanced NSCLC from mainland China; 136 patients were randomly assigned to osimertinib (80 mg , once daily; n = 71) or first-generation EGFR TKIs (gefitinib or erlotinib; both selected gefitinib 250 mg once daily; n = 65)
.
Patients were randomly assigned to treatment groups and treated until disease progression, unacceptable toxicity, or withdrawal of consent
The FLAURA China study is a double-blind, randomized, phase III study of previously untreated EGFRm (exon 19 deletion or L858R) advanced NSCLC from mainland China; 136 patients were randomly assigned to osimertinib (80 mg , once daily; n = 71) or first-generation EGFR TKIs (gefitinib or erlotinib; both selected gefitinib 250 mg once daily; n = 65)
The study included 136 patients, including 19 patients enrolled in the global study and an additional 117 Chinese patients, of whom 71 received osimertinib and 65 received gefitinib
Investigator-assessed progression-free survival (PFS) was significantly longer with osimertinib than with gefitinib, with a median PFS of 8 months, 17.
prognostic assessment
prognostic evaluationprognostic evaluationPFS
PFSPFSMedian OS was 33.
1 months (95% CI 26.
0-35.
9) and 25.
7 months (95% CI 19.
6-32.
8) in the osimertinib and gefitinib groups, respectively, which was prolonged by 7.
4 months (HR 0.
85; 95%CI 0.
56-1.
29, P=0.
442)
.
1 months (95% CI 26.
0-35.
9) and 25.
7 months (95% CI 19.
6-32.
8) in the osimertinib and gefitinib groups, respectively, which was prolonged by 7.
4 months (HR 0.
85; 95%CI 0.
56-1.
29, P=0.
442)
.
Median OS was 33.
OS
OS OSIn the subgroup analysis of PFS, almost all subgroups of patients benefited from the osimertinib group, but in the OS subgroup analysis, almost no patients benefited from the osimertinib group
.
.
In the subgroup analysis of PFS, almost all subgroups of patients benefited from the osimertinib group, but in the OS subgroup analysis, almost no patients benefited from the osimertinib group
Adverse events (AEs) of grade 3 or higher were reported in 54% and 28% of patients in the osimertinib and gefitinib groups, respectively, and no new safety signals were identified
.
.
Adverse events (AEs) of grade 3 or higher were reported in 54% and 28% of patients in the osimertinib and gefitinib groups, respectively, and no new safety signals were identified
In conclusion, the FLAURA China study showed that first-line osimertinib therapy improved the prognosis of Chinese patients with EGFR-mutant NSCLC compared with gefitinib
.
.
The FLAURA China study showed that first-line osimertinib treatment improved the prognosis of EGFR-mutant NSCLC patients in the Chinese population compared with gefitinib
Original source:
Original source:Cheng Y, He Y, Li W, Zhang HL, Zhou Q, Wang B, Liu C, Walding A, Saggese M, Huang X, Fan M, Wang J, Ramalingam SS.
Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study.
Target Oncol.
2021 Mar;16(2):165-176.
doi: 10.
1007/s11523-021-00794-6.
Epub 2021 Feb 5.
PMID: 33544337; PMCID : PMC7935816.
Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study.
Target Oncol.
2021 Mar;16(2):165-176.
doi: 10.
1007/s11523-021-00794-6.
Epub 2021 Feb 5.
PMID: 33544337; PMCID : PMC7935816.
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