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Updated: Sep 11, 2025
Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids
Published on: November 22, 2021
Real-world clinical experience with osimertinib in advanced EGFR-mutated non-small cell lung cancer
María Carmen Areses Manrique1, Luis León-Mateos2,3, Sofia Silva-Díaz4
1Medical Oncology Department, University Clinical Hospital of Ourense, Calle Ramon Puga Noguerol, 54, 32005, Ourense, Spain. Maria.Carmen.Areses.Manrique@sergas.es.
Purpose:
We aimed to evaluate the effectiveness and safety of osimertinib as a first-line therapy in patients with advanced EGFR-mutated non-small cell lung cancer (aNSCLC) in a Spanish real-world setting.
Methods:
This retrospective observational study was conducted at eight centers. The primary objective was to assess the effect of osimertinib on progression-free survival (PFS). The secondary objective was to evaluate the objective response rate (ORR), disease control rate (DCR), overall survival (OS), and drug toxicity.
Results:
A total of 181 patients with aNSCLC were included in this study. The median PFS and OS were 15.8 (95% CI 12.5-19.0) and 29.3 (95% CI 21.1-37.5) months, respectively. An Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ≥ 2 was associated with shorter PFS, whereas the presence of common EGFR mutations (exon 19 deletion and exon 21 L858R) was associated with longer PFS. Similarly, the age ≥ 70 years and an ECOG PS ≥ 2 were associated with a shorter OS, whereas the exon 19 deletion was associated with a longer OS. In addition, the overall ORR was 71.3% (CI 95% 64.7-77.9%), and the DCR was 87.8% (CI 95% 83.1-92.6%), with exon 19 deletion associated with a greater treatment response. Finally, 77% of the patients reported mild adverse reactions. Severe toxicity was not observed.
Conclusions:
This study supports the effectiveness and tolerable safety profile of osimertinib as first-line treatment for patients with aNSCLC in a real-world setting. Exon 19 deletion appears to be a strong predictor of greater effectiveness in patients with aNSCLC.
Insights
Osimertinib shows effectiveness and safety as a first-line treatment for advanced EGFR-mutated non-small cell lung cancer (aNSCLC) in real-world Spanish settings. Exon 19 deletion predicts better outcomes in these patients.
Area of Science:
- Oncology
- Pharmacology
- Clinical Medicine
Background:
- Advanced EGFR-mutated non-small cell lung cancer (aNSCLC) requires effective first-line therapies.
- Osimertinib is a targeted therapy for EGFR-mutated NSCLC.
Purpose of the Study:
- To evaluate the real-world effectiveness and safety of osimertinib in Spanish patients with aNSCLC.
- To assess progression-free survival (PFS), objective response rate (ORR), overall survival (OS), and toxicity.
Main Methods:
- Retrospective observational study across eight Spanish centers.
- Included 181 patients with aNSCLC receiving first-line osimertinib.
- Analyzed PFS, OS, ORR, disease control rate (DCR), and adverse events.
Main Results:
- Median PFS was 15.8 months and median OS was 29.3 months.
- ORR was 71.3% and DCR was 87.8%.
- Exon 19 deletion correlated with longer PFS, OS, and higher ORR. ECOG PS ≥2 and age ≥70 were associated with poorer outcomes. Mild adverse reactions occurred in 77% of patients; severe toxicity was not observed.
Conclusions:
- Osimertinib demonstrates effectiveness and a tolerable safety profile as a first-line treatment for aNSCLC in a real-world setting.
- Exon 19 deletion is a significant predictor of enhanced treatment effectiveness in aNSCLC patients.
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