The impact of adjuvant EGFR-TKIs and 14-gene molecular assay on stage I non–small cell lung cancer with sensitive EGFR mutations

BACKGROUND: Currently, the role of EGFR-TKIs as adjuvant therapy for stage I, especially IA NSCLC, after surgical resection remains unclear. We aimed to compare the effect of adjuvant EGFR-TKIs with observation in such patients by incorporating an established 14-gene molecular assay for risk stratif...

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Detalles Bibliográficos
Autores principales: Jiang, Yu, Lin, Yuechun, Fu, Wenhai, He, Qihua, Liang, Hengrui, Zhong, Ran, Cheng, Ran, Li, Bingliang, Wen, Yaokai, Wang, Huiting, Li, Jianfu, Li, Caichen, Xiong, Shan, Chen, Songan, Xiang, Jianxing, Mann, Michael J., He, Jianxing, Liang, Wenhua
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10511786/
https://www.ncbi.nlm.nih.gov/pubmed/37745018
http://dx.doi.org/10.1016/j.eclinm.2023.102205
Descripción
Sumario:BACKGROUND: Currently, the role of EGFR-TKIs as adjuvant therapy for stage I, especially IA NSCLC, after surgical resection remains unclear. We aimed to compare the effect of adjuvant EGFR-TKIs with observation in such patients by incorporating an established 14-gene molecular assay for risk stratification. METHODS: This retrospective cohort study was conducted at the First Affiliated Hospital of Guangzhou Medical University (Study ID: ChNCRCRD-2022-GZ01). From March 2013 to February 2019, completely resected stage I NSCLC (8th TNM staging) patients with sensitive EGFR mutation were included. Patients with eligible samples for molecular risk stratification were subjected to the 14-gene prognostic assay. Inverse probability of treatment weighting (IPTW) was employed to minimize imbalances in baseline characteristics. FINDINGS: A total of 227 stage I NSCLC patients were enrolled, with 55 in EGFR-TKI group and 172 in the observation group. The median duration of follow-up was 78.4 months. After IPTW, the 5-year DFS (HR = 0.30, 95% CI, 0.14–0.67; P = 0.003) and OS (HR = 0.26, 95% CI, 0.07–0.96; P = 0.044) of the EGFR-TKI group were significantly better than the observation group. For subgroup analyses, adjuvant EGFR-TKIs were associated with favorable 5-year DFS rates in both IA (100.0% vs. 84.5%; P = 0.007), and IB group (98.8% vs. 75.3%; P = 0.008). The 14-gene assay was performed in 180 patients. Among intermediate-high-risk patients, EGFR-TKIs were associated with a significant improvement in 5-year DFS rates compared to observation (96.0% vs. 70.5%; P = 0.012), while no difference was found in low-risk patients (100.0% vs. 94.9%; P = 0.360). INTERPRETATION: Our study suggested that adjuvant EGFR-TKI might improve DFS and OS of stage IA and IB EGFR-mutated NSCLC, and the 14-gene molecular assay could help patients that would benefit the most from treatment. FUNDING: This work was supported by China National Science Foundation (82022048, 82373121).

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