Neoadjuvant Afatinib for stage III EGFR-mutant non-small cell lung cancer: a phase II study

Dongliang Bian, Liangdong Sun, Junjie Hu, Liang Duan, Haoran Xia, Xinsheng Zhu, Fenghuan Sun, Lele Zhang, Huansha Yu, Yicheng Xiong, Zhida Huang, Deping Zhao, Nan Song, Jie Yang, Xiao Bao, Wei Wu, Jie Huang, Wenxin He (), Yuming Zhu (), Gening Jiang () and Peng Zhang ()
Additional contact information
Dongliang Bian: Tongji University School of Medicine
Liangdong Sun: Tongji University School of Medicine
Junjie Hu: Tongji University School of Medicine
Liang Duan: Tongji University School of Medicine
Haoran Xia: Tongji University School of Medicine
Xinsheng Zhu: Tongji University School of Medicine
Fenghuan Sun: Tongji University School of Medicine
Lele Zhang: Tongji University
Huansha Yu: Tongji University School of Medicine
Yicheng Xiong: Tongji University School of Medicine
Zhida Huang: Tongji University School of Medicine
Deping Zhao: Tongji University School of Medicine
Nan Song: Tongji University School of Medicine
Jie Yang: Tongji University School of Medicine
Xiao Bao: Tongji University School of Medicine
Wei Wu: Tongji University School of Medicine
Jie Huang: Tongji University School of Medicine
Wenxin He: Tongji University School of Medicine
Yuming Zhu: Tongji University School of Medicine
Gening Jiang: Tongji University School of Medicine
Peng Zhang: Tongji University School of Medicine

Nature Communications, 2023, vol. 14, issue 1, 1-14

Abstract: Abstract Afatinib, an irreversible ErbB-family blocker, could improve the survival of advanced epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer patients (NSCLCm+). This phase II trial (NCT04201756) aimed to assess the feasibility of neoadjuvant Afatinib treatment for stage III NSCLCm+. Forty-seven patients received neoadjuvant Afatinib treatment (40 mg daily). The primary endpoint was objective response rate (ORR). Secondary endpoints included pathological complete response (pCR) rate, pathological downstaging rate, margin-free resection (R0) rate, event-free survival, disease-free survival, progression-free survival, overall survival, treatment-related adverse events (TRAEs). The ORR was 70.2% (95% CI: 56.5% to 84.0%), meeting the pre-specified endpoint. The major pathological response (MPR), pCR, pathological downstaging, and R0 rates were 9.1%, 3.0%, 57.6%, and 87.9%, respectively. The median survivals were not reached. The most common TRAEs were diarrhea (78.7%) and rash (78.7%). Only three patients experienced grade 3/4 TRAEs. Biomarker analysis and tumor microenvironment dynamics by bulk RNA sequencing were included as predefined exploratory endpoints. CISH expression was a promising marker for Afatinib response (AUC = 0.918). In responders, compared to baseline samples, increasing T-cell- and B-cell-related features were observed in post-treatment tumor and lymph-node samples, respectively. Neoadjuvant Afatinib is feasible for stage III NSCLC+ patients and leads to dynamic changes in the tumor microenvironment.

Date: 2023
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DOI: 10.1038/s41467-023-40349-z

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