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Impact of First-Line Osimertinib and Other EGFR-Tyrosine Kinase Inhibitors on Overall Survival in Untreated Advanced
Makoto Hibino1, Yoshinori Imamura2, Rai Shimoyama3
1Department of Respiratory Medicine, Shonan Fujisawa Tokushukai Hospital, 1-5-1 Tsujido Kandai, Fujisawa, Kanagawa, 251-0041, Japan. m-hibino@ctmc.jp.
Background:
Osimertinib shows higher effectiveness than first-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) in the initial treatment of EGFR-mutated non-small cell lung cancer. However, its superiority in terms of overall survival in the Asian population, especially Japanese patients, remains uncertain.
Objective:
To evaluate the survival benefit of osimertinib over other EGFR-TKIs in Japanese patients, using real-world data. METHODS : As part of the Tokushukai REAl-world Data project, a retrospective multi-institutional study across 46 hospitals in Japan was conducted to evaluate the overall survival of patients with advanced EGFR-mutated non-small cell lung cancer using propensity score matching. The study involved patients receiving osimertinib as the first-line treatment (1L-Osi), those initially treated with other EGFR-TKIs (1L-non-Osi), and those receiving osimertinib after initial EGFR-TKI treatment (2L/later-Osi) between April 2010 and December 2022 and followed up until April 2023.
Results:
Among 1062 Japanese patients with EGFR-mutated non-small cell lung cancer, 416 (39.2%) received 1L-Osi, while 646 (60.8%) received 1L-non-Osi, including 139 (13.1%) who received 2L/later-Osi. Within these groups, 416 (39.2%), 293 (27.6%), and 75 (7.1%) patients received first-line EGFR-TKI treatment post-osimertinib approval as a later-line treatment in Japan (March 2016). After propensity score matching, the overall survival of the 1L-Osi group was comparable to that of the 1L-non-Osi group in the post-March 2016 subset (n = 283, 42.0 vs 42.4 months). Similar trends were observed in the Del19 and L858R subgroups. The median overall survival of the 2L/later-Osi group was notably long: 60.2 months post-March 2016 (n = 75). A subgroup analysis based on initial EGFR-TKI treatment in the 1L-non-Osi and 2L/later-Osi groups revealed no significant differences among the gefitinib, erlotinib, and afatinib groups.
Conclusions:
Based on real-world data, osimertinib did not show a significant improvement in overall survival compared to other EGFR-TKIs as a first-line treatment for EGFR-mutated advanced non-small cell lung cancer in the Japanese (Asian) population.
Clinical Trial Registration:
This study was registered at the University Hospital Medical Information Network Clinical Trials Registry on 9 March, 2023 (identification UMIN000050552).
Insights
Osimertinib did not significantly improve overall survival compared to other epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) in Japanese patients with EGFR-mutated non-small cell lung cancer as a first-line treatment.
Area of Science:
- Oncology
- Pharmacology
- Genetics
Background:
- Osimertinib is effective in treating EGFR-mutated non-small cell lung cancer (NSCLC).
- Its overall survival benefit in Japanese patients as a first-line treatment is not well-established.
- Real-world data is needed to clarify its efficacy in this population.
Purpose of the Study:
- To evaluate the overall survival benefit of osimertinib versus other EGFR-TKIs in Japanese patients with advanced EGFR-mutated NSCLC.
- To compare first-line osimertinib (1L-Osi) with first-line non-osimertinib EGFR-TKIs (1L-non-Osi) and later-line osimertinib (2L/later-Osi).
Main Methods:
- Retrospective multi-institutional study of 1062 Japanese patients with advanced EGFR-mutated NSCLC.
- Propensity score matching was used to compare survival outcomes.
- Data collected from April 2010 to April 2023.
Main Results:
- First-line osimertinib showed comparable overall survival to first-line non-osimertinib EGFR-TKIs in the post-March 2016 subset (42.0 vs 42.4 months).
- Later-line osimertinib demonstrated a notable median overall survival of 60.2 months.
- No significant differences in survival were found among gefitinib, erlotinib, and afatinib in subgroup analyses.
Conclusions:
- Osimertinib did not demonstrate a significant overall survival advantage over other first-generation EGFR-TKIs as a first-line treatment in Japanese patients.
- Real-world evidence suggests comparable efficacy for first-line treatments in this population.
- Further research may explore optimal sequencing strategies.
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