Jiang Yu, Lin Yuechun, Fu Wenhai, Jiang Si, Hao Zhexue, Liang Hengrui, He Qihua, Cheng Ran, Li Bingliang, Deng Hongsheng, Li Caichen, Li Jianfu, Xiong Shan, Zhong Ran, Chen Songan, Wang Wei, He Jianxing, Liang Wenhua
Department of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, China.
Department of Ultrasonography, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Transl Lung Cancer Res. 2025 May 30;14(5):1531-1542. doi: 10.21037/tlcr-2025-20. Epub 2025 May 26.
Adjuvant epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) show promising outcomes in early-stage non-small cell lung cancer (NSCLC) with EGFR mutations, but accurately identifying patients who would derive the greatest benefit remains a clinical challenge. We compared the predictive performance of clinicopathological factors and the 14-gene assay to assess postoperative prognosis and predict the potential benefit of adjuvant EGFR-TKIs in stage I NSCLC.
From March 2013 to February 2019, patients with completely resected stage I NSCLC [8th edition tumor-node-metastasis (TNM) classification staging] and EGFR mutation were included. The 14-gene assay, assessed through quantitative reverse transcription polymerase chain reaction (qPCR), was developed and subsequently validated across diverse international cohorts. Clinicopathological high-risk factors included any feature indicating a higher risk of recurrence based on the National Comprehensive Cancer Network (NCCN) guidelines. The primary endpoint of this study was the 5-year disease-free survival (DFS) rate.
Diagnostic values were evaluated in 180 stage I NSCLC patients. The 14-gene assay demonstrated superior performance compared to clinicopathological factors in predicting recurrence events. Patients with molecular high-risk, rather than clinicopathological high-risk factors, showed a more favorable response to adjuvant EGFR-TKIs. Specifically, adjuvant EGFR-TKIs benefited molecular high-risk patients, regardless of clinicopathological high-risk (DFS rate increased from 65.9% to 95.0%, P=0.02) or low-risk subgroups (80.0% to 100%, P=0.04). Patients with molecular low risk did not show any benefit from EGFR-TKIs, regardless of clinicopathological high-risk (DFS rate increased from 93.3% to 100%, P=0.37) or low-risk subgroups (97.0% to 100%, P=0.73).
The 14-gene assay is proven to be superior to clinicopathological factors, offering valuable guidance for adjuvant EGFR-TKIs decisions in stage I NSCLC.
辅助性表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）在伴有EGFR突变的早期非小细胞肺癌（NSCLC）中显示出有前景的疗效，但准确识别能从治疗中获得最大益处的患者仍是一项临床挑战。我们比较了临床病理因素和14基因检测在评估I期NSCLC术后预后及预测辅助性EGFR-TKIs潜在获益方面的预测性能。
纳入2013年3月至2019年2月期间完全切除的I期NSCLC（第8版肿瘤-淋巴结-转移（TNM）分类分期）且伴有EGFR突变的患者。通过定量逆转录聚合酶链反应（qPCR）评估的14基因检测方法已开发完成，并随后在不同国际队列中进行了验证。临床病理高危因素包括基于美国国立综合癌症网络（NCCN）指南提示复发风险较高的任何特征。本研究的主要终点是5年无病生存率（DFS）。
对180例I期NSCLC患者的诊断价值进行了评估。在预测复发事件方面，14基因检测显示出优于临床病理因素的性能。分子高危而非临床病理高危因素的患者对辅助性EGFR-TKIs表现出更良好的反应。具体而言，辅助性EGFR-TKIs使分子高危患者获益，无论其临床病理为高危（DFS率从65.9%提高到95.0%，P=0.02）还是低危亚组（从80.0%提高到100%，P=0.04）。分子低危患者未显示从EGFR-TKIs中获得任何益处，无论其临床病理为高危（DFS率从93.3%提高到100%，P=0.37）还是低危亚组（从97.0%提高到100%，P=0.73）。
14基因检测被证明优于临床病理因素，为I期NSCLC辅助性EGFR-TKIs治疗决策提供了有价值的指导。
