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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

查看全文 作　　者：Wen-Zhao [1]Zhong;Hong-Hong [1]Yan;Ke-Neng [2]Chen;Chun [3]Chen;Chun-Dong [4]Gu;Jun [5]Wang;Xue-Ning [1]Yang;Wei-Min [6]Mao;Qun [7]Wang;Gui-Bin [1,8]Qiao;Ying [9]Cheng;Lin [10]Xu;Chang-Li [11]Wang;Ming-Wei [12]Chen;Xiao-Zheng [2]Kang;Wan-Pu [2]Yan;Ri-Qiang [1]Liao;Jin-Ji [1]Yang;Xu-Chao [1]Zhang;Si-Yang [1]Liu;Qing [1]Zhou;Yi-Long [1]Wu 高影响力作者 机构地区：[1]Guangdong Provincial People’s Hospital,Guangdong Academy of Medical Sciences,510080 Guangzhou,China;[2]Peking University Cancer Hospital and Institute,100142 Beijing,China;[3]Fujian Medical University Union Hospital,350001 Fuzhou,China;[4]First Affiliated Hospital of Dalian Medical University,116011 Dalian,China;[5]Peking University People’s Hospital,100044 Beijing,China;[6]Zhejiang Cancer Hospital,310022 Hangzhou,China;[7]Zhongshan Hospital,200032 Shanghai,China;[8]Guangzhou Liuhuaqiao Hospital,510000 Guangzhou,China;[9]Jilin Provincial Tumor Hospital,130012 Changchun,China;[10]Jiangsu Cancer Institute and Hospital,210009 Nanjing,China;[11]Tianjin Medical University Cancer Institute and Hospital,300060 Tianjin,China;[12]First Affiliated Hospital of Xi’an Jiaotong University,710061 Xi’an,China高影响力机构 出　　处：《Signal Transduction and Targeted Therapy》索引2023年第8卷第3期,共8页高影响力期刊 基　　金：The authors thank all patients and their families.The authors would like to acknowledge the editorial support provided by Keyra Martinez Dunn,MD,of Edanz(www.edanz.com),which was funded by Shanghai Roche Pharmaceutical Ltd.This study was funded by the Chinese Thoracic Oncology Group(CTONG),Shanghai Roche Pharmaceutical Ltd. 摘　　要：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/m2 plus cisplatin 75 mg/m2 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-y)ear 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. 关 键 词：NEOADJUVANT CISPLATIN chemotherapy
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