Determining the prevalence of EGFR mutations in patients with advanced non-small
PUBLISHED: 2015-11-26  558 total views, 2 today

Chunlei Shi1, Meng-zhao Wang2, Yong He3, Yi-ping Zhang4, Sergei Tjulandin5, MarianneRatcliffe6, Rose Mccormack6, Baohui Han

1Department ofRespiratory Medicine, Shanghai Chest Hospital, Jiao Tong University, Shanghai,China, 2Department ofRespiratory Medicine, Peking union   Medical College Hospital, Peking union  Medical College and Chinese Academy of Medical Sciences, Beijing, China, 3Department ofRespiratory Medicine, Daping Hospital, The Third Military Medical University,Chongquing, China, 4Department ofChemotherapy, Zhejiang Cancer Hospital and Key Laboratory Diagnosis andTreatment Technology on Thoracic Oncology, Hangzhou, China, 5Department of ClinicalPharmacology and Chemotherapy, Russian Cancer Research Center, Moscow,Russia, 6AstraZeneca,Macclesfield, UK


Objective:IGNITE (a large, multinational,diagnostic, non-comparative, interventional study; NCT01788163) assessed EGFRmutation frequency in patients with advanced NSCLC of adenocarcinoma(ADC)/non-ADC histology in Chinese patients. Method: Eligible patients:local/metastatic a NSCLC (chemotherapy-naïve, newly diagnosed/recurrent diseaseafter resection) from 26 centres in China; Primary endpoint: EGFR mutationfrequency by histology (locally tested). Secondary endpoints: EGFR mutationstatus concordance between matched tissue/cytology and plasma (circulating-freetumour-derived cf-DNA) samples; correlation between mutation status anddemographic/disease status; treatment decisions; EGFR testing practices. Result:1458 pts enrolled; tissue/cytology evaluable: 1391; plasma evaluable: 1421.Tissue/cytology EGFR mutation frequency (China): ADC: 51.3%; non-ADC: 11.1%;plasma generally lower. Mutation status concordance in 1355 matched samples:77.6% (95%CI 75.2–79.8); test sensitivity: 48.7% (44.5–53.0); specificity:97.1% (95.8–98.2); positive predictive value (PPV): 92.1% (88.3–94.9); negativePV: 73.6% (70.9–76.2). PPV in 606 samples tested with identical highlysensitive methods: 94.3%. Mutation frequency significantly correlated with:ADC; never-smokers; greater number of metastatic organs; females(tissue/cytology only); age ≥65 years (plasma only). Conclusion: TheIGNITE study further confirms that adenocarcinoma histology, never-smokingstatus and Asian ethnicity are significantly correlated with EGFRmutation-positive status. Plasma ctDNA may be used for patients where a tumoursample is not available/evaluable to determine EGFR mutation status. EGFRmutation status and histology data indicate that EGFR mutation testing shouldbe considered in patients with NSCLC of adenocarcinoma and non-adenocarcinomahistology.


Key Words: non-small-cell lung cancer

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