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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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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
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关键词: afatinib gefitinib NSCLC overall survival

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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.

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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
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第一作者机构: [1]Univ Complutense, Hosp Univ Doce Octubre, Dept Med Oncol, Madrid, Spain; [2]CNIO, Madrid, Spain;
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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
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