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Proffered paper session - Non-metastatic NSCLC and other thoracic malignancies

3170 - CTONG 1103:Erlotinib versus Gemcitabine plus Cisplatin as Neo-adjuvant Treatment for Stage IIIA –N2 EGFR-mutation Non-small-cell lung cancer (EMERGING): a Randomised Study


21 Oct 2018


Proffered paper session - Non-metastatic NSCLC and other thoracic malignancies


Cytotoxic Therapy;  Targeted Therapy

Tumour Site


Wen-Zhao Zhong


W. Zhong1, Y. Wu2, K. Chen3, C. Chen4, C. Gu5, Q. Wang6, J. Wang7, W. Mao8, G. Qiao9, Y. Cheng10, L. Xu11, C. Wang12, M. Chen13, X. Yang1, H. Chen1, H. Yang1, J. Yang2, Q. Zhou2

Author affiliations

  • 1 Guangdong Lung Cancer Institute, Guangdong General Hospital, 510080 - Guangzhou/CN
  • 2 Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, 510080 - Guangzhou/CN
  • 3 Thoracic Department, Beijing Cancer Hospital, Beijing/CN
  • 4 Thoracic Department, Fujian Medical University Union Hospital, Fuzhou/CN
  • 5 Thoracic Department, The 1st hospital affiliated Dalian Medical University, Dalian/CN
  • 6 Thoracic Department, Fudan University Affiliated Zhongshan Hospital, Shanghai/CN
  • 7 Thoracic Department, The People’s Hospital of Peking University, Beijing/CN
  • 8 Zhejiang Cancer Hospital, Department of Thoracic Surgery, hangzhou/CN
  • 9 Guangdong Lung Cancer Institute, Thoracic Surgery department, 510080 - Guangzhou/CN
  • 10 Department Of Thoracic Oncology, Jilin Provincial Cancer Hospital, Changchun/CN
  • 11 Thoracic Surgery Department, Jiangsu Cancer Hospital, Nanjing/CN
  • 12 Thoracic Surgery Department, Tianjin Cancer Hospital, Tianjin/CN
  • 13 Thoracic Surgery Department, The 1st hospital affiliated Xi'An Jiaotong University, Xi'an/CN


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Abstract 3170


Cisplatin-based doublet chemotherapy as neoadjuvant treatment for IIIA-N2 non-small cell lung cancer (NSCLC) give patients 5% survival benefit. EGFR-TKIs have been proved to prolong PFS of advanced EGFR-mutant NSCLC. CTONG1104 trial shown adjuvant gefitinib could improve 10 months (disease free survival) DFS than chemotherapy in N1/N2 resected NSCLC. It raises the possibility that EGFR-TKIs may play a beneficial role in the neoadjuvant setting. We conducted this randomized trial to compare the efficacy of erlotinib (E) and gemcitabine plus cisplatin (GC) as neoadjuvant/adjuvant treatment.


Eligible patients with N2 disease were randomly assigned in 1:1 ratio to E group for 42 days as neoadjuvant therapy and then for 12 months after surgery or GC group for 2 cycles neoadjuvant chemotherapy and 2 cycles after complete resection. The primary endpoint is objective response rate (ORR). secondary endpoints included downstaging rates of pathological lymph nodes, pathological complete response (pCR), progression-free survival (PFS), overall survival (OS), safety, and tolerability.


A total of 386 patients from 17 centers were screened, 72 were randomized and included in the intention-to-treat population. The ORR for neoadjuvant E versus GC was 54.1% (95% CI, 37.2% to 70.9%) vs 34.3% (95% CI, 17.7% to 50.8%) (OR 2.26; 95% CI, 0·87–5.84; p=0·092). After neoadjuvant therapy, 31 patients (83·8%) in the E group and 24 (68·6%) in the GC group underwent surgery. Overall, lymph node downstaging occurred in 13% in the E and 4·2% in the GC group. The major pathological response (MPR) occurred in 3 of 28 patients (10.7%) in the E and no MPR (0/22) in the GC group. Median PFS was significantly longer with E (21·5 months; 95% CI, 19·3–23·6) versus GC (11·9 months; 95% CI, 9·1–14·7; HR 0·42; 95% CI, 0·23–0·76; p=0·003), whereas OS data was immature. The incidence of grade 3/4 toxicities was lower in the E group (0%) than that in the GC group (29·4%). No unexpected AEs were found.


Neoadjuvant/adjuvant erlotinib improved ORR, and significantly prolonged PFS compared with GC chemotherapy in patients with stage IIIA-N2 EGFR mutation NSCLC.

Clinical trial identification


Editorial Acknowledgement


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