Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
- 1 Clinical Question
- 2 Bottom Line
- 3 Major Points
- 4 Guidelines
- 5 Design
- 6 Population
- 7 Interventions
- 8 Outcomes
- 9 Criticisms
- 10 Funding
- 11 Further Reading
In patients with previously untreated EGFR-mutated advanced non-small-cell lung cancer does the use of osimertinib compared to standard EGFR-TKI treatment provide a progression-free survival benefit without increasing serious adverse events or harm?
In patients with previously untreated EGFR-mutated advanced non-small-cell lung cancer (NSCLC) osimertinib treatment resulted in longer progression-free survival compared to current standard first-line therapy with a similar safety profile.
NCCN guidelines list multiple epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) (erlotinib, afatinib, gefitinib, and osimertinib) as first-line therapies in the treatment of EGFR-mutated advanced NSCLC. Previous studies have shown these TKIs to be more or less equal in efficacy with similar side-effect profiles. The FLAURA investigation examined the first-line use of the third-generation EGFR-TKI osimertinib in previously untreated EGFR mutation positive advanced NSCLC and showed a significantly longer progression-free survival and median duration of response compared to either gefitinib or erlotinib while showing less grade 3 or higher adverse events. The overall survival analysis was determined not significant at the interim analysis but data are still being collected.
No changes to guidelines as of yet.
- International-Multicenter, Double-blind, randomized, controlled trial
- N= 556
- Osimertinib (n=279)
- Standard EGFR-TKI (n=277; Gefitinib=183, Erlotinib=94)
- Setting: 132 sites in 29 countries
- Enrollment: December 2014 through March 2016
- Mean follow-up:
- Analysis: Intention-to-treat
- Primary outcome: Duration of progression-free survival as determined by investigator assessments, according to RECIST version 1.1.
- Demographics: Age ## years, ## female
Comparisons are GROUP 1 vs. GROUP 2.
- NAME OF OUTCOME
- ##% vs. ##% (HR ##; 95% CI ##-##; P=##)