Erlotinib versus gemcitabine plus cisplatin as neoadjuvant treatment of stage IIIA-N2 EGFR-mutant non-small-cell lung cancer: final overall survival analysis of the EMERGING-CTONG 1103 randomised phase II trial

• DOI: 10.1038/s41392-022-01286-3
• Publication Date: 2023-02-24T01:02:43Z
• Authors: Wen-Zhao Zhong; Hong-Hong Yan; Ke-Neng Chen; Chun Chen; Chun-Dong Gu; Jun Wang; Xue-Ning Yang; Wei-Min Mao; Qun Wang; Gui-Bin Qiao; Ying Cheng; Lin Xu; Chang-Li Wang; Ming-Wei Chen; Xiao-Zheng Kang; Wan-Pu Yan; Ri-Qiang Liao; Jin-Ji Yang; Xu-Chao Zhang; Si-Yang Liu; Qing Zhou; Yi-Long Wu
• Keywords: Erlotinib Hydrochloride; Neoadjuvant Therapy

Abstract EMERGING-CTONG 1103 showed improved progression-free survival (PFS) with neoadjuvant erlotinib vs. chemotherapy for patients harbouring EGFR sensibility mutations and R0 resected stage IIIA-N2 non-small cell lung cancer (NSCLC) (NCT01407822). Herein, we report the final results. Recruited were randomly allocated 1:1 to group (150 mg/day orally; phase 42 days adjuvant 12 months) or GC (gemcitabine 1250 mg/m 2 plus cisplatin 75 intravenously; cycles in phase). Objective response rate (ORR), complete pathologic (pCR), PFS, overall (OS) assessed along safety. Post hoc analysis was performed subsequent treatments after disease recurrence. Among investigated 72 (erlotinib, n = 37; GC, 35), median follow-up 62.5 months. The OS 42.2 months (erlotinib) 36.9 (GC) (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.47–1.47; p 0.513). 3- 5-year rates 58.6% 40.8% 55.9% 27.6% ( 3-y 0.819, 5-y 0.252). Subsequent treatment administered 71.9% 81.8% of receiving respectively; targeted therapy contributed mostly (HR, 0.35; CI, 0.18–0.70). After progression, ORR 53.3%, PFS 10.9 during EGFR-TKI rechallenge. During postoperative therapy, grade 3 4 adverse events (AEs) 13.5% 29.4% group. No serious observed. Erlotinib exhibited clinical feasibility resectable NSCLC over setting.