EGFR mutation prevalence in Asia-Pacific and Russian patients with advanced NSCLC of adenocarcinoma and non-adenocarcinoma histology: The IGNITE study. (November 2017)

• Record Type: Journal Article
• Authors: Han, Baohui; Tjulandin, Sergei; Hagiwara, Koichi; Normanno, Nicola; Wulandari, Laksmi; Laktionov, Konstantin; Hudoyo, Achmad; He, Yong; Zhang, Yi-Ping; Wang, Meng-Zhao; Liu, Chien Ying; Ratcliffe, Marianne; McCormack, Rose; Reck, Martin
• Is Part Of: Lung cancer. Volume 113(2017)
• Page Start: 37
• Page End: 44
• Publication Date: 2017-11
• Subjects: 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; Adenocarcinoma -- Circulating free tumour-derived DNA -- Diagnostic -- Epidermal growth factor receptor -- Non-small-cell lung cancer; Lungs -- Cancer -- Periodicals; Lung Neoplasms -- Abstracts; Lung Neoplasms -- Periodicals; Poumons -- Cancer -- Périodiques; Lungs -- Cancer; Periodicals; Electronic journals; Electronic journals; 616.99424
• DOI: 10.1016/j.lungcan.2017.08.021
• Languages: English
• ISSNs: 0169-5002

Abstract

Highlights: IGNITE is a diagnostic, non-interventional study conducted across Asia/Russia [80/85 characters incl. spaces] . EGFR m freq. was higher in ADC tissue samples (Asia/Russia 49/18%) vs non-ADC (14/4%) [84/85 characters incl. spaces] . Of Russian SCC samples that were EGFR m (4%), most (67%) were from never/former-smokers [85/85 characters incl. spaces] . EGFR testing is advocated in all Asian NSCLC patients [57/85 characters incl. spaces] . ctDNA is feasible for EGFR testing (tissue vs plasma mutation concordance: 80%) [82/85 characters incl. spaces] . 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.