Cancer treatment and research communications · 2025
Real-world comparative outcomes of EGFR-TKIs for first-line treatment of EGFR+ metastatic non-small-cell lung cancer.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Kim Kibum, Syeed Sakil, Au Trang, Diaz Amber, Schabath Matthew B, Cass Amanda, Hall Richard, Pai Lori, Li Chenghui, Balmaceda Nicole, Palumbo Alison, Carey Autumn, Lalla Mumtu, Henry Matthew, Brixner Diana, Stenehjem David
Аннотация
PURPOSE: Osimertinib is a third-generation EGFR-TKI and preferred first-line (1L) treatment for EGFR positive (EGFR+) metastatic non-small cell lung cancer (mNSCLC). This study compared real-world clinical outcomes of 1L osimertinib versus 1st or 2nd generation EGFR-TKIs (1/2G-TKIs) in patients with EGFR+ mNSCLC.
METHODS: Nine academic cancer centers in the US participated in the retrospective cohort study. Patients aged ≥18 years with EGFR+ mNSCLC and treated with 1L EGFR-TKI were included. Clinical outcomes included real-world progression-free survival (rwPFS), duration of treatment (DOT), time to next treatment (TTNT), central nervous system incidence-free survival (CNS-IFS), and overall survival (OS). Multivariable regression models were used to control for differences in patient characteristics (p < 0.1) between the osimertinib and 1/2G-TKI cohorts.
RESULTS: The study included 181 osimertinib patients and 171 1/2G-TKI patients. Osimertinib had a longer rwPFS compared to 1/2G-TKIs (median PFS, 95 % confidence interval [CI]: 16.2 months (13.2-19.7) vs. 10.8 months (9.5-12.7); hazard Ratio [HR], 95 % CI: 0.60 (0.44-0.82). DOT and TTNT were significantly longer in patients treated with osimertinib versus 1/2G-TKI (HR, 95 % CI: 0.51 (0.38-0.68) for DOT; 0.54 (0.39-0.74) for TTNT). The respective HR point estimate for CNF-IFS and OS of 0.62 and 0.83 preferred osimertinib. However, small patient counts and number of events posed challenges in drawing conclusion regarding the significance of the delayed CNS-IFS or OS.
CONCLUSION: Patients treated with osimertinib had a prolonged time to progression and longer time maintain the treatment compared to 1/2G-TKI. This real-world evidence is aligned with clinical trial results.
METHODS: Nine academic cancer centers in the US participated in the retrospective cohort study. Patients aged ≥18 years with EGFR+ mNSCLC and treated with 1L EGFR-TKI were included. Clinical outcomes included real-world progression-free survival (rwPFS), duration of treatment (DOT), time to next treatment (TTNT), central nervous system incidence-free survival (CNS-IFS), and overall survival (OS). Multivariable regression models were used to control for differences in patient characteristics (p < 0.1) between the osimertinib and 1/2G-TKI cohorts.
RESULTS: The study included 181 osimertinib patients and 171 1/2G-TKI patients. Osimertinib had a longer rwPFS compared to 1/2G-TKIs (median PFS, 95 % confidence interval [CI]: 16.2 months (13.2-19.7) vs. 10.8 months (9.5-12.7); hazard Ratio [HR], 95 % CI: 0.60 (0.44-0.82). DOT and TTNT were significantly longer in patients treated with osimertinib versus 1/2G-TKI (HR, 95 % CI: 0.51 (0.38-0.68) for DOT; 0.54 (0.39-0.74) for TTNT). The respective HR point estimate for CNF-IFS and OS of 0.62 and 0.83 preferred osimertinib. However, small patient counts and number of events posed challenges in drawing conclusion regarding the significance of the delayed CNS-IFS or OS.
CONCLUSION: Patients treated with osimertinib had a prolonged time to progression and longer time maintain the treatment compared to 1/2G-TKI. This real-world evidence is aligned with clinical trial results.