Paz-Ares LTan E.-HO'Byrne KZhang LHirsh VBoyer MCHIH-HSIN YANGMok TLee K.HLu SShi YLee D.HLaskin JKim D.-WLaurie S.AKölbeck KFan JDodd NMärten APark K.2020-05-262020-05-2620170923-7534https://www.scopus.com/inward/record.uri?eid=2-s2.0-85015712569&doi=10.1093%2fannonc%2fmdw611&partnerID=40&md5=2d80cbe7aa1b93d226fa7aa184566d41https://scholars.lib.ntu.edu.tw/handle/123456789/494963Background: 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-na?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. ? The Author 2016.Afatinib; Gefitinib; NSCLC; Overall survival[SDGs]SDG3afatinib; epidermal growth factor receptor; erlotinib; gefitinib; olmutinib; osimertinib; poziotinib; afatinib; antineoplastic agent; EGFR protein, human; epidermal growth factor receptor; gefitinib; quinazoline derivative; acne; adult; Article; brain metastasis; cancer staging; diarrhea; drug substitution; drug treatment failure; drug withdrawal; EGFR gene; exon; fatigue; follow up; gene deletion; gene mutation; human; hypertransaminasemia; interstitial lung disease; kidney failure; liver failure; major clinical study; multicenter study (topic); non small cell lung cancer; overall survival; phase 2 clinical trial (topic); priority journal; proportional hazards model; randomized controlled trial (topic); rash; treatment response; aged; clinical trial; comparative study; controlled study; female; genetics; Kaplan Meier method; lung tumor; male; middle aged; mortality; mutation; non small cell lung cancer; phase 2 clinical trial; randomized controlled trial; treatment outcome; Aged; Antineoplastic Agents; Carcinoma, Non-Small-Cell Lung; Female; Humans; Kaplan-Meier Estimate; Lung Neoplasms; Male; Middle Aged; Mutation; Proportional Hazards Models; Quinazolines; Receptor, Epidermal Growth Factor; Treatment Outcomejournal article10.1093/annonc/mdw611284261062-s2.0-85015712569