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

• Published in: EClinicalMedicine Vol. 64; p. 102205
• Main Authors: Yu Jiang, Yuechun Lin, Wenhai Fu, Qihua He, Hengrui Liang, Ran Zhong, Ran Cheng, Bingliang Li, Yaokai Wen, Huiting Wang, Jianfu Li, Caichen Li, Shan Xiong, Songan Chen, Jianxing Xiang, Michael J. Mann, Jianxing He, Wenhua Liang
• Format: Journal Article
• Language: English
• Published: Elsevier 01.10.2023
• Subjects: Adjuvant therapy; EGFR-TKI; Non–small-cell lung cancer; Risk stratification; Stage I
• ISSN: 2589-5370; 2589-5370

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).