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Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial

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作者：
Paz-Ares, L.[1,2] * ; Tan, E. -H.[3] ; O'Byrne, K.[4,5] ; Zhang, L.[6] ; Hirsh, V.[7] ; Boyer, M.[8] ; Yang, J. C. -H.[9,10] ; Mok, T.[11] ; Lee, K. H.[12] ; Lu, S.[13] ; Shi, Y.[14,15] ; Lee, D. H.[16] ; Laskin, J.[17] ; Kim, D. -W.[18] ; Laurie, S. A.[19] ; Kolbeck, K.[20] ; Fan, J.[21] ; Dodd, N.[22] ; Marten, A.[23] ; Park, K.[24] ;
机构： [1]Univ Complutense, Hosp Univ Doce Octubre, Dept Med Oncol, Madrid, Spain; [2]CNIO, Madrid, Spain; [3]Natl Canc Ctr, Div Med Oncol, Singapore, Singapore; [4]Princess Alexandra Hosp, Canc Sect, Brisbane, Qld, Australia; [5]Queensland Univ Technol, Brisbane, Qld, Australia; [6]Sun Yat Sen Univ, Ctr Canc, State Key Lab Oncol South China, Collaborat Innovat Ctr Canc Med, Guangzhou, Guangdong, Peoples R China; [7]McGill Univ, Dept Oncol, Montreal, PQ, Canada; [8]Chris OBrien Lifehouse, Dept Med Oncol, Camperdown, NSW, Australia; [9]Natl Taiwan Univ Hosp, Dept Oncol, Taipei, Taiwan; [10]Natl Taiwan Univ, Taipei, Taiwan; [11]Chinese Univ Hong Kong, Dept Clin Oncol, State Key Lab South China, Hong Kong, Hong Kong, Peoples R China; [12]Chungbuk Natl Univ Hosp, Dept Internal Med, Cheongju, Chungbuk, South Korea; [13]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai, Peoples R China; [14]Chinese Acad Med Sci, Dept Med Oncol, Beijing Key Lab Clin Study Anticanc Mol Targeted, Natl Canc Ctr,Canc Hosp, Beijing, Peoples R China; [15]Peking Union Med Coll, Beijing, Peoples R China; [16]Asan Med Ctr, Dept Oncol, Seoul, South Korea; [17]BC Canc Agcy, Med Oncol, Vancouver, BC, Canada; [18]Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea; [19]Ottawa Hosp, Ctr Canc, Div Med Oncol, Ottawa, ON, Canada; [20]Karolinska Univ Hosp, Pulm Dis, Stockholm, Sweden; [21]Boehringer Ingelheim Pharmaceut Inc, Ottawa, ON, Canada; [22]Boehringer Ingelheim Ltd UK, Biostat, Bracknell, Berks, England; [23]Boehringer Ingelheim GmbH & Co KG, TA Oncol, Ingelheim, Germany; [24]Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Div Hematol Oncol, Seoul, South Korea; [25]Hosp Univ Doce Octubre, Dept Med Oncol, Ave Cordoba S-N, Madrid 28041, Spain
出处：
DOI： 10.1093/annonc/mdw611
ISSN：

关键词： afatinib gefitinib NSCLC overall survival

摘要：
Background: In LUX-Lung 7, the irreversible ErbB family blocker, afatinib, significantly improved progression-free survival (PFS), time-to-treatment failure (TTF) and objective response rate (ORR) versus gefitinib in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). Here, we present primary analysis of mature overall survival (OS) data. Patients and methods: LUX-Lung 7 assessed afatinib 40 mg/day versus gefitinib 250 mg/day in treatment-nai " ve patients with stage IIIb/IV NSCLC and a common EGFR mutation (exon 19 deletion/L858R). Primary OS analysis was planned after 213 OS events and 32-month follow-up. OS was analysed by a Cox proportional hazards model, stratified by EGFR mutation type and baseline brain metastases. Results: Two-hundred and twenty-six OS events had occurred at the data cut-off (8 April 2016). After a median follow-up of 42.6 months, median OS (afatinib versus gefitinib) was 27.9 versus 24.5 months [hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.66-1.12, P 0.2580]. Prespecified subgroup analyses showed similar OS trends (afatinib versus gefitinib) in patients with exon 19 deletion (30.7 versus 26.4 months; HR, 0.83, 95% CI 0.58-1.17, P 0.2841) and L858R (25.0 versus 21.2 months; HR 0.91, 95% CI 0.62-1.36, P 0.6585) mutations. Most patients (afatinib, 72.6%; gefitinib, 76.8%) had at least one subsequent systemic anti-cancer treatment following discontinuation of afatinib/gefitinib; 20 (13.7%) and 23 (15.2%) patients received a thirdgeneration EGFR tyrosine kinase inhibitor. Updated PFS (independent review), TTF and ORR data were significantly improved with afatinib. Conclusion: In LUX-Lung 7, there was no significant difference in OS with afatinib versus gefitinib. Updated PFS (independent review), TTF and ORR data were significantly improved with afatinib.

基金：
Boehringer IngelheimBoehringer Ingelheim; Lynn Pritchard of GeoMed; Ashfield company, part of UDG Healthcare plc
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外文
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PubmedID：
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
第一作者：
第一作者机构： [1]Univ Complutense, Hosp Univ Doce Octubre, Dept Med Oncol, Madrid, Spain; [2]CNIO, Madrid, Spain;
通讯作者：
通讯机构： [1]Univ Complutense, Hosp Univ Doce Octubre, Dept Med Oncol, Madrid, Spain; [2]CNIO, Madrid, Spain; [25]Hosp Univ Doce Octubre, Dept Med Oncol, Ave Cordoba S-N, Madrid 28041, Spain
推荐引用方式(GB/T 7714)：
Paz-Ares L.,Tan E. -H.,O'Byrne K.,et al.Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial[J].ANNALS OF ONCOLOGY.2017,28(2):270-277.doi:10.1093/annonc/mdw611.
APA：
Paz-Ares, L.,Tan, E. -H.,O'Byrne, K.,Zhang, L.,Hirsh, V....&Park, K..(2017).Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial.ANNALS OF ONCOLOGY,28,(2)
MLA：
Paz-Ares, L.,et al."Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial".ANNALS OF ONCOLOGY 28..2(2017):270-277

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