Nature communications · 2026
Clinical utility of molecular residual disease detection in early-stage resected EGFR-mutated non-small cell lung cancer.
СтатьяКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Zhou Fei, Su Chunxia, Liang Wenhua, Xu Li-Di, Tao Wei, Qian Juanjuan, Xu Shidong, Liu Dan, Fan Rui, Zhang Yaxi, Liu Yiqian, Wu Lin, Fu Xiangning, Zhang Xiaodong, Shen Ning, Ge Di, Chen Qun, Mao Weimin, Xu Lin, Chen Chun, Hu Bing, Shao Guoguang, Hu Jian, Zhao Jian, Liu Xiaoqing, Liu Zhidong, Wang Zheng, Xiao Zemin, Gong Taiqian, Lin Wen, Li Xingya, Ye Feng, Liu Yang, Ma Haitao, Huang Yunchao, Zhou Jianying, Wang Zhonglin, Fu Junke, Ding Lieming, Mao Li, Chen Weizhi, He Jianxing, Zhou Caicun
Аннотация
Molecular residual disease (MRD), detected through circulating tumor DNA, has emerged as a promising biomarker for surveillance in patients with early-stage non-small cell lung cancer (NSCLC) following curative-intent resection. Here we report the MRD analysis from the phase 3 EVIDENCE trial, which includes patients with stage II-IIIA resected EGFR-mutated NSCLC who have received either adjuvant icotinib or chemotherapy. A total of 1,352 plasma samples from 175 patients are analyzed using the MinerVa Prime assay, a personalized tumor-informed MRD platform. At the landmark timepoint, MinerVa Prime detects MRD positivity in 35.8% (38/106) of patients with stage III disease and 14.7% (10/68) of patients with stage II disease, with a longitudinal positivity rate of 47.4%. MRD-positive status is significantly correlated with inferior disease-free survival (DFS), both at landmark (hazard ratio [HR]: 4.44, P < 0.001) and during longitudinal monitoring (HR: 7.82, P < 0.001). Icotinib confers DFS benefits over chemotherapy in both MRD subgroups, enhancing MRD clearance in MRD-positive patients while reducing molecular recurrence in landmark MRD-negative patients. Longitudinal MRD shows a 91.3% negative predictive value, with a median lead time of 169 days prior to clinical recurrence. Among serial monitoring timepoints, MRD status at 24 weeks post-randomization demonstrates the highest prognostic value.