Translational lung cancer research · 2026
Efficacy and safety of third-generation EGFR-TKI rechallenge therapy in advanced non-small cell lung cancer patients with EGFR mutation: a retrospective cohort study.
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Sun Jiajie, Li Xinjing, Wang Bingxue, Chen Zhangxuan, Yao Yang, Wu Ranpu, Pan Xiaohua, Xu Xuanhao, Si Yunxiao, Liu Hongbing
Аннотация
BACKGROUND: Third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have become the standard treatment for EGFR-mutant non-small cell lung cancer (NSCLC), but acquired resistance remains inevitable. Current post-progression salvage regimens offer only modest clinical benefits, leaving an unmet need for effective late-line treatment strategies. This study evaluated the efficacy and safety of third-generation EGFR-TKI rechallenge as a potential salvage option for heavily pretreated resistant NSCLC patients.
METHODS: We retrospectively analyzed 29 patients with advanced EGFR-mutant NSCLC who received third-generation EGFR-TKI rechallenge after progression on prior third-generation EGFR-TKI therapy between December 2019 and August 2025. All patients had pathologically confirmed EGFR-mutant lung adenocarcinoma and received multi-line subsequent treatment after third-generation EGFR-TKIs resistance. Baseline clinical data were extracted from electronic medical records, and follow-up chest CT evaluations were conducted every 6 to 8 weeks. Outcomes were standardized using RECIST version 1.1 for tumor responses and CTCAE version 5.0 for adverse events. Survival outcomes [progression-free survival (PFS), overall survival (OS)] were analyzed via Kaplan-Meier curves and log-rank tests. The primary endpoint was PFS. Secondary endpoints included OS and disease control rate (DCR).
RESULTS: The median number of prior systemic treatment lines was 5 (range, 3-12). Third-generation EGFR-TKI rechallenge achieved a median progression-free survival (mPFS) of 6.0 months, a median overall survival (mOS) of 12.0 months. The DCR was 6/29 (20.7%). Treatment-related adverse events (TRAEs) occurred in 8/29 (27.6%) patients, with severe (grade ≥3) events in 3/29 (10.3%). Poorer baseline ECOG PS (3-4) was significantly associated with inferior PFS (median: 5.0 vs. 7.0 months, P=0.04) and OS (median: 10.0 vs. 25.0 months, P=0.005). Chemotherapy-containing interval therapy was associated with improved PFS (7.5 vs. 2.0 months, P=0.02).
CONCLUSIONS: Third-generation EGFR-TKI rechallenge may provide a feasible and well-tolerated salvage option for selected heavily pretreated patients with EGFR-mutant NSCLC. ECOG PS and prior treatment patterns may assist in patient selection for rechallenge therapy. However, these findings are strictly exploratory and require validation in larger, controlled prospective studies.
METHODS: We retrospectively analyzed 29 patients with advanced EGFR-mutant NSCLC who received third-generation EGFR-TKI rechallenge after progression on prior third-generation EGFR-TKI therapy between December 2019 and August 2025. All patients had pathologically confirmed EGFR-mutant lung adenocarcinoma and received multi-line subsequent treatment after third-generation EGFR-TKIs resistance. Baseline clinical data were extracted from electronic medical records, and follow-up chest CT evaluations were conducted every 6 to 8 weeks. Outcomes were standardized using RECIST version 1.1 for tumor responses and CTCAE version 5.0 for adverse events. Survival outcomes [progression-free survival (PFS), overall survival (OS)] were analyzed via Kaplan-Meier curves and log-rank tests. The primary endpoint was PFS. Secondary endpoints included OS and disease control rate (DCR).
RESULTS: The median number of prior systemic treatment lines was 5 (range, 3-12). Third-generation EGFR-TKI rechallenge achieved a median progression-free survival (mPFS) of 6.0 months, a median overall survival (mOS) of 12.0 months. The DCR was 6/29 (20.7%). Treatment-related adverse events (TRAEs) occurred in 8/29 (27.6%) patients, with severe (grade ≥3) events in 3/29 (10.3%). Poorer baseline ECOG PS (3-4) was significantly associated with inferior PFS (median: 5.0 vs. 7.0 months, P=0.04) and OS (median: 10.0 vs. 25.0 months, P=0.005). Chemotherapy-containing interval therapy was associated with improved PFS (7.5 vs. 2.0 months, P=0.02).
CONCLUSIONS: Third-generation EGFR-TKI rechallenge may provide a feasible and well-tolerated salvage option for selected heavily pretreated patients with EGFR-mutant NSCLC. ECOG PS and prior treatment patterns may assist in patient selection for rechallenge therapy. However, these findings are strictly exploratory and require validation in larger, controlled prospective studies.