Baohui Han1, Sergei Tjulandin2, Koichi Hagiwara3, Nicola Normanno4, Laksmi Wulandari5, Konstantin Laktionov6, Achmad Hudoyo7, Yong He8, Yi-Ping Zhang9, Meng-Zhao Wang10, Chien Ying Liu11, Marianne Ratcliffe12, Rose McCormack12, Martin Reck13. 1. Department of Respiratory Medicine, Shanghai Chest Hospital, Jiao Tong University, 241 Huaihai West Road, Shanghai, 200030, China. Electronic address: xkyyhan@gmail.com. 2. Department of Clinical Pharmacology and Chemotherapy, N. N. Blokhin Russian Cancer Research Center, 24 Kashirskoye Shosse, Moscow, 115478, Russia. 3. Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, 329-0498, Japan. 4. Cell Biology and Biotherapy Unit, Istituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Via Mariano Semmola, Napoli, 80131, Italy. 5. Department of Pulmonology, Dr Soetomo General Hospital, No. 6-8 Surabaya, Jawa Timur, 60285, Indonesia. 6. Department of Clinical Biotechnology, N. N. Blokhin Russian Cancer Research Center, 24 Kashirskoye Shosse, Moscow, 115478, Russia. 7. 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. 8. Department of Respiratory Medicine, Daping Hospital, The Third Military Medical University, No.10 Daping Changjiang Branch Road, Chongqing, 400042, China. 9. Department of Chemotherapy, Zhejiang Cancer Hospital and Key Laboratory Diagnosis and Treatment Technology on Thoracic Oncology, 38 Guangji Road, Hangzhou, Zhejiang, 10022, China. 10. 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. 11. Division of Thoracic Medicine, Chang Gung Memorial Hospital, Chang Gung University, 199 Tung Hwa North Road, Taipei, 105, Taiwan. 12. AstraZeneca, Mereside, Alderley Park, Macclesfield, SK10 4TG, United Kingdom. 13. Department of Thoracic Oncology, LungenClinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Centre for Lung Research (DZL), Wöhrendamm 80, Grosshansdorf, 22927, Germany.
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/recurrent 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 mutations were observed in a small number of Caucasian squamous NSCLC patients, testing here may be appropriate, particularly in those with no/remote smoking history. Circulating free tumour-derived DNA is feasible for mutation analysis employing well-validated and sensitive methods, when tumour samples are unavailable.
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/recurrent 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 mutations were observed in a small number of Caucasian squamous NSCLCpatients, testing here may be appropriate, particularly in those with no/remote smoking history. Circulating free tumour-derived DNA is feasible for mutation analysis employing well-validated and sensitive methods, when tumour samples are unavailable.
Authors: Jamal Zaini; Elisna Syahruddin; Muhammad Yunus; Sita Laksmi Andarini; Achmad Hudoyo; Najmiatul Masykura; Refniwita Yasril; Asep Ridwanuloh; Heriawaty Hidajat; Fariz Nurwidya; Sony Suharsono; Ahmad R H Utomo Journal: Cancer Rep (Hoboken) Date: 2019-02-03