{"title":"第三代与第一代EGFR酪氨酸激酶抑制剂在亚洲晚期EGFR突变非小细胞肺癌患者中的应用：一项随机对照试验的荟萃分析","authors":"Manzhen Xu, Wei Ding, Linlin Wan, Wenxiong Zhang","doi":"10.1007/s12672-025-03767-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Third-generation EGFR-TKIs (TGETs) have demonstrated improved clinical outcomes compared to first-generation EGFR-TKIs (FGETs) in patients with EGFR-mutant non-small-cell lung cancer (NSCLC). Nonetheless, the comparative safety and efficacy of TGETs as a first-line option for Asian patients with advanced EGFR-mutant NSCLC remain unclear. This meta-analysis aims to compare the survival outcomes, response rates, and adverse events (AEs) of TGETs versus FGETs in this population.</p><p><strong>Methods: </strong>We systematically searched 6 databases for eligible phase 3 randomized controlled trials (RCTs). Eligible studies included those comparing TGETs with FGETs in previously untreated Asian patients with EGFR-mutant advanced NSCLC. Pooled hazard ratios (HRs) for progression-free survival (PFS) and overall survival (OS), risk ratios (RRs) for response rates, and AEs were calculated and analyzed.</p><p><strong>Results: </strong>Seven phase 3 RCTs comprising 2434 Asian patients were included. TGETs significantly improved PFS (HR: 0.47 [0.42, 0.52], P < 0.00001) and central nervous system-PFS (HR: 0.57 [0.40, 0.80], P = 0.001) compared to FGETs. A trend toward improved OS was also observed with TGETs (HR: 0.88 [0.75, 1.03], P = 0.10). The advantages of PFS in the TGET group were confirmed in all subgroups. The objective response rate (ORR) (RR: 1.05 [1.01, 1.09], P = 0.03) and duration of response (DOR) (HR: 0.41 [0.34, 0.48], P < 0.00001) were also better in the TGET group. Total/grade 3-5 treatment-emergent AEs (TEAEs) and Total/grade 3-5 treatment-related AEs (TRAEs) were similar between the two groups. The top 3 TEAEs of TGET group were diarrhea (31.72%), rash (30.90%), and platelet count decreased (27.97%).</p><p><strong>Conclusion: </strong>Compared with FGETs, TGETs significantly improve PFS, CNS control, response outcomes, and maintain a comparable safety profile for Asian patients with advanced EGFR-mutated NSCLC.</p>","PeriodicalId":11148,"journal":{"name":"Discover. Oncology","volume":"16 1","pages":"1932"},"PeriodicalIF":2.9000,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12540962/pdf/","citationCount":"0","resultStr":"{\"title\":\"Third-generation versus first-generation EGFR tyrosine kinase inhibitors in Asian patients with advanced EGFR mutant non-small cell lung cancer: a meta-analysis of randomized controlled trials.\",\"authors\":\"Manzhen Xu, Wei Ding, Linlin Wan, Wenxiong Zhang\",\"doi\":\"10.1007/s12672-025-03767-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Third-generation EGFR-TKIs (TGETs) have demonstrated improved clinical outcomes compared to first-generation EGFR-TKIs (FGETs) in patients with EGFR-mutant non-small-cell lung cancer (NSCLC). Nonetheless, the comparative safety and efficacy of TGETs as a first-line option for Asian patients with advanced EGFR-mutant NSCLC remain unclear. This meta-analysis aims to compare the survival outcomes, response rates, and adverse events (AEs) of TGETs versus FGETs in this population.</p><p><strong>Methods: </strong>We systematically searched 6 databases for eligible phase 3 randomized controlled trials (RCTs). Eligible studies included those comparing TGETs with FGETs in previously untreated Asian patients with EGFR-mutant advanced NSCLC. Pooled hazard ratios (HRs) for progression-free survival (PFS) and overall survival (OS), risk ratios (RRs) for response rates, and AEs were calculated and analyzed.</p><p><strong>Results: </strong>Seven phase 3 RCTs comprising 2434 Asian patients were included. TGETs significantly improved PFS (HR: 0.47 [0.42, 0.52], P < 0.00001) and central nervous system-PFS (HR: 0.57 [0.40, 0.80], P = 0.001) compared to FGETs. A trend toward improved OS was also observed with TGETs (HR: 0.88 [0.75, 1.03], P = 0.10). The advantages of PFS in the TGET group were confirmed in all subgroups. The objective response rate (ORR) (RR: 1.05 [1.01, 1.09], P = 0.03) and duration of response (DOR) (HR: 0.41 [0.34, 0.48], P < 0.00001) were also better in the TGET group. Total/grade 3-5 treatment-emergent AEs (TEAEs) and Total/grade 3-5 treatment-related AEs (TRAEs) were similar between the two groups. The top 3 TEAEs of TGET group were diarrhea (31.72%), rash (30.90%), and platelet count decreased (27.97%).</p><p><strong>Conclusion: </strong>Compared with FGETs, TGETs significantly improve PFS, CNS control, response outcomes, and maintain a comparable safety profile for Asian patients with advanced EGFR-mutated NSCLC.</p>\",\"PeriodicalId\":11148,\"journal\":{\"name\":\"Discover. Oncology\",\"volume\":\"16 1\",\"pages\":\"1932\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-10-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12540962/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Discover. Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s12672-025-03767-7\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Discover. Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s12672-025-03767-7","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Third-generation versus first-generation EGFR tyrosine kinase inhibitors in Asian patients with advanced EGFR mutant non-small cell lung cancer: a meta-analysis of randomized controlled trials.
Background: Third-generation EGFR-TKIs (TGETs) have demonstrated improved clinical outcomes compared to first-generation EGFR-TKIs (FGETs) in patients with EGFR-mutant non-small-cell lung cancer (NSCLC). Nonetheless, the comparative safety and efficacy of TGETs as a first-line option for Asian patients with advanced EGFR-mutant NSCLC remain unclear. This meta-analysis aims to compare the survival outcomes, response rates, and adverse events (AEs) of TGETs versus FGETs in this population.
Methods: We systematically searched 6 databases for eligible phase 3 randomized controlled trials (RCTs). Eligible studies included those comparing TGETs with FGETs in previously untreated Asian patients with EGFR-mutant advanced NSCLC. Pooled hazard ratios (HRs) for progression-free survival (PFS) and overall survival (OS), risk ratios (RRs) for response rates, and AEs were calculated and analyzed.
Results: Seven phase 3 RCTs comprising 2434 Asian patients were included. TGETs significantly improved PFS (HR: 0.47 [0.42, 0.52], P < 0.00001) and central nervous system-PFS (HR: 0.57 [0.40, 0.80], P = 0.001) compared to FGETs. A trend toward improved OS was also observed with TGETs (HR: 0.88 [0.75, 1.03], P = 0.10). The advantages of PFS in the TGET group were confirmed in all subgroups. The objective response rate (ORR) (RR: 1.05 [1.01, 1.09], P = 0.03) and duration of response (DOR) (HR: 0.41 [0.34, 0.48], P < 0.00001) were also better in the TGET group. Total/grade 3-5 treatment-emergent AEs (TEAEs) and Total/grade 3-5 treatment-related AEs (TRAEs) were similar between the two groups. The top 3 TEAEs of TGET group were diarrhea (31.72%), rash (30.90%), and platelet count decreased (27.97%).
Conclusion: Compared with FGETs, TGETs significantly improve PFS, CNS control, response outcomes, and maintain a comparable safety profile for Asian patients with advanced EGFR-mutated NSCLC.
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