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First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma (CONVINCE): a phase 3, open-label, randomized study

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收录情况： ◇ SCIE

作者：
Y. K. Shi[1] * ; L. Wang[1] ; B. H. Han[2] ; W. Li[3] ; P. Yu[4] ; Y. P. Liu[5] ; C. M. Ding[6] ; X. Song[7] ; Z. Y. Ma[8] ; X. L. Ren[9] ; J. F. Feng[10] ; H. L. Zhang[11] ; G. Y. Chen[12] ; X. H. Han[1] ; N. Wu[13] ; C. Yao[14] ; Y. Song[15] ; S. C. Zhang[16] ; W. Song[17] ; X. Q. Liu[18] ; S. J. Zhao[13] ; Y. C. Lin[19] ; X. Q. Ye[20] ; K. Li[21] ; Y. Q. Shu[22] ; L. M. Ding[23] ; F. L. Tan[23] ; Y. Sun[1,*1] ;
机构： [1]Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing [2]Department of Pulmonology, Shanghai Chest Hospital, Shanghai [3]Department of Oncology, The First Hospital Affiliated to Jilin University, Changchun [4]Department of Lung Cancer Medical Oncology, Sichuan Cancer Hospital,Chengdu [5]Department of Medical Oncology, The First Hospital of China Medical University, Shenyang [6]Department of Respiratory Medicine, The Fourth Hospitalof Hebei Medical University, Shijiazhuang [7]Department of Respiratory Medicine, Shanxi Provincial Tumor Hospital, Taiyuan [8]Department of Oncology, HenanCancer Hospital, Zhengzhou [9]Department of Respiratory Medicine, Xijing Hospital, The Fourth Military Medical University, Xi’an [10]Department of Oncology,Jiangsu Cancer Hospital, Nanjing [11]Department of Oncology, Tangdu Hospital, The Fourth Military Medical University, Xi’an [12]Department of Medical Oncology,The Affiliated Tumor Hospital of Harbin Medical University, Harbin [13]Department of Imaging Diagnosis, National Cancer Center/Cancer Hospital, ChineseAcademy of Medical Sciences and Peking Union Medical College, Beijing [14]Department of Biostatistics, Peking University Clinical Research Institute, Beijing [15]Department of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine, Nanjing [16]Department of Medical Oncology, Beijing Chest Hospital,Capital Medical University, Beijing [17]Department of Radiology, Peking Union Medical College Hospital, Beijing [18]Department of Pulmonary Oncology, The 307thHospital of Chinese People’s Liberation Army, Beijing [19]Department of Medical Oncology, Cancer Hospital of Shantou University Medical College, Shantou [20]Department of Respiratory Diseases, The Second Affiliated Hospital of Nanchang University, Nanchang [21]Department of Thoracic Oncology, Tianjin Medical UniversityCancer Institute and Hospital, Tianjin [22]Department of Oncology, Jiangsu Provincial Hospital, Nanjing [23]Betta Pharmaceuticals Co., Ltd, Hangzhou, China
出处：
DOI： 10.1093/annonc/mdx359
ISSN：

关键词： NSCLC icotinib first-line EGFR mutation-positive cisplatin/pemetrexed plus pemetrexed maintenance

摘要：
Background: Icotinib has been previously shown to be non-inferior to gefitinib in non-selected advanced non-small-cell lung cancer patients when given as second-or further-line treatment. In this open-label, randomized, phase 3 CONVINCE trial, we assessed the efficacy and safety of first-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance in lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutation. Patients and methods: Eligible participants were adults with stage IIIB/IV lung adenocarcinoma and exon 19/21 EGFR mutations. Participants were randomly allocated (1 : 1) to receive oral icotinib or 3-week cycle of cisplatin plus pemetrexed for up to four cycles; non-progressive patients after four cycles were maintained with pemetrexed until disease progression or intolerable toxicity. The primary end point was progression-free survival (PFS) assessed by independent response evaluation committee. Other end points included overall survival (OS) and safety. Results: Between January 2013 and August 2014, 296 patients were randomized, and 285 patients were treated (148 to icotinib, 137 to chemotherapy). Independent response evaluation committee-assessed PFS was significantly longer in the icotinib group (11.2 versus 7.9months; hazard ratio, 0.61, 95% confidence interval 0.43-0.87; P = 0.006). No significant difference for OS was observed between treatments in the overall population or in EGFR-mutated subgroups (exon 19 Del/21 L858R). The most common grade 3 or 4 adverse events (AEs) in the icotinib group were rash (14.8%) and diarrhea (7.4%), compared with nausea (45.9%), vomiting (29.2%), and neutropenia (10.9%) in the chemotherapy group. AEs (79.1% versus 94.2%; P < 0.001) and treatment-related AEs (54.1% versus 90.5%; P < 0.001) were significantly fewer in the icotinib group than in the chemotherapy group. Conclusions: First-line icotinib significantly improves PFS of advanced lung adenocarcinoma patients with EGFR mutation with a tolerable and manageable safety profile. Icotinib should be considered as a first-line treatment for this patient population.

基金：
Betta Pharmaceuticals Co., Ltd.; National Key Special Program for Innovative Drugs [2012ZX09101103, 2013ZX09101002, 2012ZX09303012-001]
语种：
外文
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中科院(CAS)分区：
出版当年[2017]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
JCR分区：
出版当年[2017]版：
Q1 ONCOLOGY
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2017版] 出版当年五年平均 出版前一年[2016版] 出版后一年[2018版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing
通讯作者：
通讯机构： [1]Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing [*1]Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
推荐引用方式(GB/T 7714)：
Y. K. Shi,L. Wang,B. H. Han,et al.First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma (CONVINCE): a phase 3, open-label, randomized study[J].ANNALS OF ONCOLOGY.2017,28(10):2443-2450.doi:10.1093/annonc/mdx359.
APA：
Y. K. Shi,L. Wang,B. H. Han,W. Li,P. Yu...&Y. Sun.(2017).First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma (CONVINCE): a phase 3, open-label, randomized study.ANNALS OF ONCOLOGY,28,(10)
MLA：
Y. K. Shi,et al."First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma (CONVINCE): a phase 3, open-label, randomized study".ANNALS OF ONCOLOGY 28..10(2017):2443-2450

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