Contents lists available at ScienceDirect Lung Cancer journal homepage: www.elsevier.com/locate/lungcan EGFR mutation prevalence in Asia-Pacific and Russian patients with advanced NSCLC of adenocarcinoma and non-adenocarcinoma histology: The IGNITE study Baohui Han a, ⁎ , Sergei Tjulandin b , Koichi Hagiwara c , Nicola Normanno d , Laksmi Wulandari e , Konstantin Laktionov f , Achmad Hudoyo g , Yong He h , Yi-Ping Zhang i , Meng-Zhao Wang j , Chien Ying Liu k , Marianne Ratcliffe l , Rose McCormack l , Martin Reck m a Department of Respiratory Medicine, Shanghai Chest Hospital, Jiao Tong University, 241 Huaihai West Road, Shanghai, 200030, China b Department of Clinical Pharmacology and Chemotherapy, N. N. Blokhin Russian Cancer Research Center, 24 Kashirskoye Shosse, Moscow 115478, Russia c Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, 329-0498, Japan d Cell Biology and Biotherapy Unit, Istituto Nazionale Tumori “Fondazione Giovanni Pascale”, IRCCS, Via Mariano Semmola, 80131 Napoli, Italy e Department of Pulmonology, Dr Soetomo General Hospital, No. 6-8 Surabaya, Jawa Timur, 60285 Indonesia f Department of Clinical Biotechnology, N. N. Blokhin Russian Cancer Research Center, 24 Kashirskoye Shosse, Moscow 115478, Russia g Department of Pulmonology and Respiratory Medicine, Faculty of Medicine, University of Indonesia – Persahabatan Hospital, 2nd Floor Jl. Persahabatan Raya No. 1, Rawamangun, Jakarta 13230, Indonesia h Department of Respiratory Medicine, Daping Hospital, The Third Military Medical University, No.10 Daping Changjiang Branch Road, Chongqing, 400042, China i Department of Chemotherapy, Zhejiang Cancer Hospital and Key Laboratory Diagnosis and Treatment Technology on Thoracic Oncology, 38 Guangji Road, Hangzhou, Zhejiang, 10022, China j Department of Respiratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, No. 1 Shuaifuyuan Street, Dongcheng District, Beijing, 100730, China k Division of Thoracic Medicine, Chang Gung Memorial Hospital, Chang Gung University, 199 Tung Hwa North Road, Taipei 105, Taiwan l AstraZeneca, Mereside, Alderley Park, Macclesfield, SK10 4TG, United Kingdom m Department of Thoracic Oncology, LungenClinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Centre for Lung Research (DZL), Wöhrendamm 80, 22927 Grosshansdorf, Germany ARTICLE INFO Keywords: Adenocarcinoma Circulating free tumour-derived DNA Diagnostic Non-small-cell lung cancer ABSTRACT Objectives: Limited understanding exists of epidermal growth factor receptor (EGFR) mutation frequency in less common subgroups of advanced non-small-cell lung cancer (aNSCLC) (e.g. squamous cell carcinoma [SCC]), and to what extent local practices exclude patients from EGFR testing based on their clinical characteristics. Materials and methods: IGNITE (non-comparative/-interventional; NCT01788163) was conducted in 90 centres (Asia-Pacific/Russia). Eligible patients: local/metastatic aNSCLC; chemotherapy-naïve, newly-diagnosed/re- current disease after resection; ineligible for curative treatment. Patients provided a tissue/cytology (all) and a blood plasma (China/Russia/South Korea/Taiwan) sample. Primary endpoint: EGFR mutation frequency in aNSCLC patients (adenocarcinoma [ADC]/non-ADC), as per local practices. Results: 3382 patients were enrolled. EGFR mutation frequencies for evaluable tissue/cytology samples in Asia- Pacific and Russian patients: 49.3% (862/1749) and 18.0% (90/500) for ADC tumours; 14.1% (74/525) and 3.7% (15/402) for non-ADC; 9.9% (40/403) and 3.7% (13/349) for SCC. Of Russian patients with SCC tumours harbouring common, activating EGFR mutations, 6/9 were never-/former-smokers. Mutation status concordance between 2581 matched tissue/cytology and plasma samples: 80.5% (sensitivity 46.9%, specificity 95.6%). Conclusion: EGFR mutation testing should be considered in all Asian aNSCLC patients. Also, as activating EGFR http://dx.doi.org/10.1016/j.lungcan.2017.08.021 Received 22 June 2017; Received in revised form 25 August 2017; Accepted 28 August 2017 ⁎ Corresponding author. E-mail addresses: xkyyhan@gmail.com, hanxkyy@aliyun.com (B. Han). Abbreviations: ADC, adenocarcinoma; aNSCLC, advanced non-small-cell lung cancer; ASR, age-standardised rate; ctDNA, circulating free tumour-derived DNA; EGFR, epidermal growth factor receptor; LNA, locked nucleic acid; NE, neuroendocrine; NSCC, non-small-cell carcinoma; NSCLC, non-small-cell lung cancer; NPV, negative predictive value; PCR, polymerase chain reaction; PNA, peptide nucleic acid; PPV, positive predictive value; SCC, squamous cell carcinoma; SCCA, small-cell carcinoma; TKI, tyrosine kinase inhibitor; TTF-1, thyroid transcription factor 1; WHO, World Health Organization Lung Cancer 113 (2017) 37–44 0169-5002/ © 2017 Elsevier B.V. All rights reserved. MARK