Cancer Res Treat.  2023 Jan;55(1):112-122. 10.4143/crt.2022.381.

Real-World Study of Osimertinib in Korean Patients with Epidermal Growth Factor Receptor T790M Mutation–Positive Non–Small Cell Lung Cancer

• Lee JH
• Kim EY
• Park CK
• Lee SY
• Lee Mk
• Yoon SH
• Lee JE
• Lee SH
• Kim SJ
• Lee SY
• Lim JH
• Jang TW
• Jang SH
• Lee KY
• Lee SH
• Yang SH
• Park DW
• Park CK
• Kang HS
• Yeo CD
• Choi CM
• Lee JC

• KMID: 2537997
• DOI: http://doi.org/10.4143/crt.2022.381

Abstract

Purpose
Although osimertinib is the standard-of-care treatment of epidermal growth factor receptor (EGFR) T790M mutation–positive non–small cell lung cancer, real-world evidence on the efficacy of osimertinib is not enough to reflect the complexity of the entire course of treatment. Herein, we report on the use of osimertinib in patients with EGFR T790M mutation–positive non–small cell lung cancer who had previously received EGFR tyrosine kinase inhibitor (TKI) treatment in Korea.
Materials and Methods
Patients with confirmed EGFR T790M after disease progression of prior EGFR-TKI were enrolled and administered osimertinib 80 mg daily. The primary effectiveness outcome was progression-free survival, with time-to-treatment discontinuation, treatment and adverse effects leading to treatment discontinuation, and overall survival being the secondary endpoints.
Results
A total of 558 individuals were enrolled, and 55.2% had investigator-assessed responses. The median progression-free survival was 14.2 months (95% confidence interval [CI], 13.0 to 16.4), and the median time-to-treatment discontinuation was 15.0 months (95% CI, 14.1 to 15.9). The median overall survival was 36.7 months (95% CI, 30.9 to not reached). The benefit with osimertinib was consistent regardless of the age, sex, smoking history, and primary EGFR mutation subtype. However, hepatic metastases at the time of diagnosis, the presence of plasma EGFR T790M, and the shorter duration of prior EGFR-TKI treatment were poor predictors of osimertinib treatment. Ten patients (1.8%), including three with pneumonitis, had to discontinue osimertinib due to severe adverse effects.
Conclusion
Osimertinib demonstrated its clinical effectiveness and survival benefit for EGFR T790M mutation–positive in Korean patients with no new safety signals.

Keyword

Osimertinib; T790M; Non-small cell lung cancer; Real-world efficacy

Figure

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  Fig. 1 Progression-free survival (PFS) (A) and overall survival (OS) (B) in patients treated with osimertinib. We illustrated the median PFS and OS with 95% confidence intervals (CI) in patients treated with osimertinib. NA, not available.

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  Fig. 2 Forest plots of progression-free survival (PFS) according to subgroups. We presented the median PFS with 95% confidence interval (CI) in patients treated with osimertinib according to subgroups. Positive blood EGFR (epidermal growth factor receptor) T790M mutation test results, concurrent hepatic metastasis at diagnosis, and use of prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) agents for a period of less than 8 months were related to shorter PFS. CNS, central nervous system.

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  Fig. 3 Overall survival (OS) in enrolled patients treated with osimertinib according to subgroups. We presented the median OS with 95% confidence interval (CI) in enrolled patients treated with osimertinib. We compared OS according to subgroups classified by the number of metastatic organs at diagnosis (A), concurrent central nervous system (CNS) (B), hepatic (C), bone and locomotor metastasis (D) at diagnosis, presence of plasma EGFR (epidermal growth factor receptor tyrosine) T790M mutation (E), and duration of prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) agents (F). All factors were related to considerable differences in OS. NA, not available.

Reference

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