Lan Xuyan, Sun Xiaoyu, Chen Ruiqi, Zhu Lihuan, Pan Xiaojie, Guo Tianxing
Shengli Clinical Medical College, Fujian Medical University, Fuzhou, Fujian, China.
Department of Thoracic Surgery, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial Hospital, Fuzhou, Fujian, China.
Front Mol Biosci. 2025 Jul 10;12:1619139. doi: 10.3389/fmolb.2025.1619139. eCollection 2025.
OBJECTIVE: To evaluate the predictive accuracy of the 14-gene molecular assay in determining treatment response among patients with non-small cell lung cancer (NSCLC) undergoing neoadjuvant immunochemotherapy (nICT). Additionally, the study aims to investigate its correlation with tumor-infiltrating lymphocyte (TIL) levels and the status of tertiary lymphoid structures (TLS) in the tumor microenvironment. METHODS: Patients with NSCLC who underwent nICT followed by surgical resection at Fuzhou University Affiliated Provincial Hospital between February 2019 and December 2022 were retrospectively included. Risk stratification was performed using the 14-gene quantitative PCR expression assay. The percentage of residual viable tumor cells (%RVT), TIL, and TLS within the primary lesion were evaluated through hematoxylin and eosin staining of surgical specimens. Subsequently, correlations were analyzed between the 14-gene molecular risk stratification and pathological response, as well as between the 14-gene molecular risk stratification and patient prognosis. RESULTS: A total of 114 patients were included. The pathological complete response (pCR) rate was significantly higher in the 14-gene low-risk group, while the RVT was notably lower (both < 0.05). Additionally, the low-risk group showed significantly elevated levels of TIL and positivity for TLS (both < 0.05). Survival analysis revealed that patients in the low-risk group had markedly longer disease-free survival (DFS) compared to those in the intermediate-risk and high-risk groups (both P < 0.05). Univariate Cox regression analysis identified pathological TNM stage, vascular invasion, pathological response, and 14-gene molecular risk stratification as significant factors influencing DFS (all < 0.05). Furthermore, multivariate analysis confirmed that the 14-gene risk stratification was an independent prognostic factor for DFS (HR = 2.496, : 1.264-4.931, = 0.008). CONCLUSION: The 14-gene molecular assay demonstrated that low-risk status correlates with improved pathological response and prognosis, potentially attributable to higher TLS positivity rates and increased TIL infiltration. This assay offers critical insights for refining neoadjuvant treatment strategies in patients with NSCLC.
目的：评估14基因分子检测在确定接受新辅助免疫化疗（nICT）的非小细胞肺癌（NSCLC）患者治疗反应中的预测准确性。此外，该研究旨在调查其与肿瘤微环境中肿瘤浸润淋巴细胞（TIL）水平及三级淋巴结构（TLS）状态的相关性。 方法：回顾性纳入2019年2月至2022年12月在福建医科大学附属省立医院接受nICT后行手术切除的NSCLC患者。采用14基因定量PCR表达检测进行风险分层。通过手术标本的苏木精-伊红染色评估原发灶内残余存活肿瘤细胞百分比（%RVT）、TIL和TLS。随后，分析14基因分子风险分层与病理反应之间以及14基因分子风险分层与患者预后之间的相关性。 结果：共纳入114例患者。14基因低风险组的病理完全缓解（pCR）率显著更高，而RVT显著更低（均P<0.05）。此外，低风险组的TIL水平显著升高且TLS阳性率更高（均P<0.05）。生存分析显示，与中风险组和高风险组相比，低风险组患者的无病生存期（DFS）明显更长（均P<0.05）。单因素Cox回归分析确定病理TNM分期、血管侵犯、病理反应和14基因分子风险分层为影响DFS的显著因素（均P<0.05）。此外，多因素分析证实14基因风险分层是DFS的独立预后因素（HR=2.496，95%CI：1.264-4.931，P=0.008）。 结论：14基因分子检测表明，低风险状态与更好的病理反应和预后相关，这可能归因于更高的TLS阳性率和增加的TIL浸润。该检测为优化NSCLC患者的新辅助治疗策略提供了关键见解。
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