PMID- 36823150
OWN - NLM
STAT- MEDLINE
DCOM- 20230227
LR  - 20230310
IS  - 2059-3635 (Electronic)
IS  - 2095-9907 (Print)
IS  - 2059-3635 (Linking)
VI  - 8
IP  - 1
DP  - 2023 Feb 24
TI  - 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.
PG  - 76
LID - 10.1038/s41392-022-01286-3 [doi]
LID - 76
AB  - 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 patients were 
      randomly allocated 1:1 to the erlotinib group (150 mg/day orally; neoadjuvant 
      phase for 42 days and adjuvant phase to 12 months) or to the GC group 
      (gemcitabine 1250 mg/m(2) plus cisplatin 75 mg/m(2) intravenously; 2 cycles in 
      neoadjuvant phase and 2 cycles in adjuvant phase). Objective response rate (ORR), 
      complete pathologic response (pCR), PFS, and overall survival (OS) were assessed 
      along with safety. Post hoc analysis was performed for subsequent treatments 
      after disease recurrence. Among investigated 72 patients (erlotinib, n = 37; GC, 
      n = 35), the median follow-up was 62.5 months. The median OS was 42.2 months 
      (erlotinib) and 36.9 months (GC) (hazard ratio [HR], 0.83; 95% confidence 
      interval [CI], 0.47-1.47; p = 0.513). The 3- and 5-year OS rates were 58.6% and 
      40.8% with erlotinib and 55.9% and 27.6% with GC (p(3-y) = 0.819, 
      p(5-y) = 0.252). Subsequent treatment was administered in 71.9% and 81.8% of 
      patients receiving erlotinib and GC, respectively; targeted therapy contributed 
      mostly to OS (HR, 0.35; 95% CI, 0.18-0.70). After disease progression, the ORR 
      was 53.3%, and the median PFS was 10.9 months during the EGFR-TKI rechallenge. 
      During postoperative therapy, grade 3 or 4 adverse events (AEs) were 13.5% in the 
      erlotinib group and 29.4% in the GC group. No serious adverse events were 
      observed. Erlotinib exhibited clinical feasibility for resectable IIIA-N2 NSCLC 
      over chemotherapy in the neoadjuvant setting.
CI  - (c) 2022. The Author(s).
FAU - Zhong, Wen-Zhao
AU  - Zhong WZ
AD  - Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 
      510080, Guangzhou, China.
FAU - Yan, Hong-Hong
AU  - Yan HH
AUID- ORCID: 0000-0002-6228-2096
AD  - Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 
      510080, Guangzhou, China.
FAU - Chen, Ke-Neng
AU  - Chen KN
AD  - Peking University Cancer Hospital and Institute, 100142, Beijing, China.
FAU - Chen, Chun
AU  - Chen C
AD  - Fujian Medical University Union Hospital, 350001, Fuzhou, China.
FAU - Gu, Chun-Dong
AU  - Gu CD
AD  - First Affiliated Hospital of Dalian Medical University, 116011, Dalian, China.
FAU - Wang, Jun
AU  - Wang J
AD  - Peking University People's Hospital, 100044, Beijing, China.
FAU - Yang, Xue-Ning
AU  - Yang XN
AD  - Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 
      510080, Guangzhou, China.
FAU - Mao, Wei-Min
AU  - Mao WM
AD  - Zhejiang Cancer Hospital, 310022, Hangzhou, China.
FAU - Wang, Qun
AU  - Wang Q
AD  - Zhongshan Hospital, 200032, Shanghai, China.
FAU - Qiao, Gui-Bin
AU  - Qiao GB
AD  - Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 
      510080, Guangzhou, China.
AD  - Guangzhou Liuhuaqiao Hospital, 510000, Guangzhou, China.
FAU - Cheng, Ying
AU  - Cheng Y
AUID- ORCID: 0000-0001-9908-597X
AD  - Jilin Provincial Tumor Hospital, 130012, Changchun, China.
FAU - Xu, Lin
AU  - Xu L
AD  - Jiangsu Cancer Institute and Hospital, 210009, Nanjing, China.
FAU - Wang, Chang-Li
AU  - Wang CL
AD  - Tianjin Medical University Cancer Institute and Hospital, 300060, Tianjin, China.
FAU - Chen, Ming-Wei
AU  - Chen MW
AD  - First Affiliated Hospital of Xi'an Jiaotong University, 710061, Xi'an, China.
FAU - Kang, Xiao-Zheng
AU  - Kang XZ
AD  - Peking University Cancer Hospital and Institute, 100142, Beijing, China.
FAU - Yan, Wan-Pu
AU  - Yan WP
AD  - Peking University Cancer Hospital and Institute, 100142, Beijing, China.
FAU - Liao, Ri-Qiang
AU  - Liao RQ
AD  - Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 
      510080, Guangzhou, China.
FAU - Yang, Jin-Ji
AU  - Yang JJ
AD  - Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 
      510080, Guangzhou, China.
FAU - Zhang, Xu-Chao
AU  - Zhang XC
AD  - Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 
      510080, Guangzhou, China.
FAU - Liu, Si-Yang
AU  - Liu SY
AD  - Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 
      510080, Guangzhou, China.
FAU - Zhou, Qing
AU  - Zhou Q
AD  - Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 
      510080, Guangzhou, China.
FAU - Wu, Yi-Long
AU  - Wu YL
AUID- ORCID: 0000-0002-3611-0258
AD  - Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 
      510080, Guangzhou, China. syylwu@live.cn.
LA  - eng
SI  - ClinicalTrials.gov/NCT01407822
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230224
PL  - England
TA  - Signal Transduct Target Ther
JT  - Signal transduction and targeted therapy
JID - 101676423
RN  - DA87705X9K (Erlotinib Hydrochloride)
RN  - Q20Q21Q62J (Cisplatin)
RN  - 0 (Gemcitabine)
RN  - 0 (Protein Kinase Inhibitors)
RN  - EC 2.7.10.1 (ErbB Receptors)
RN  - 0W860991D6 (Deoxycytidine)
RN  - EC 2.7.10.1 (EGFR protein, human)
SB  - IM
MH  - Humans
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics/pathology
MH  - Erlotinib Hydrochloride
MH  - Cisplatin
MH  - Gemcitabine
MH  - Neoadjuvant Therapy
MH  - *Lung Neoplasms/drug therapy/genetics/pathology
MH  - Protein Kinase Inhibitors
MH  - ErbB Receptors/genetics
MH  - Deoxycytidine
MH  - Survival Analysis
PMC - PMC9950485
COIS- Y.-L.W. reports receiving speaker bureau fees from AstraZeneca, Bristol-Myers 
      Squibb, Pfizer Inc., Roche AG, Boehringer Ingelheim, Eli Lilly & Co., Merck Sharp 
      & Dohme, and Sanofi and research grants from AstraZeneca, Bristol-Myers Squibb, 
      Pfizer Inc., and Roche AG. W.-Z.Z. reports receiving speaker fees from 
      AstraZeneca and Roche. All other authors declare no competing interests.
EDAT- 2023/02/24 06:00
MHDA- 2023/03/03 06:00
PMCR- 2023/02/24
CRDT- 2023/02/23 23:44
PHST- 2022/05/03 00:00 [received]
PHST- 2022/12/08 00:00 [accepted]
PHST- 2022/12/08 00:00 [revised]
PHST- 2023/02/23 23:44 [entrez]
PHST- 2023/02/24 06:00 [pubmed]
PHST- 2023/03/03 06:00 [medline]
PHST- 2023/02/24 00:00 [pmc-release]
AID - 10.1038/s41392-022-01286-3 [pii]
AID - 1286 [pii]
AID - 10.1038/s41392-022-01286-3 [doi]
PST - epublish
SO  - Signal Transduct Target Ther. 2023 Feb 24;8(1):76. doi: 
      10.1038/s41392-022-01286-3.