IGNITE (a large, multinational, diagnostic, non-comparative, interventional study; NCT01788163) assessed EGFR mutation frequency in patients with advanced NSCLC of adenocarcinoma(ADC)/non-ADC histology in Chinese patients.IGNITE (a large, multinational, diagnostic, non-comparative, interventional study; NCT01788163) assessed EGFR mutation frequency in patients with advanced NSCLC of adenocarcinoma(ADC)/non-ADC histology in Chinese patients.
Eligible patients: local/metastatic aNSCLC (chemotherapy-naÃ¯ve, newly diagnosed/recurrent disease after resection) from 26 centers in China; Primary endpoint: EGFR mutation frequency by histology (locally tested). Secondary endpoints: EGFR mutation status concordance between matched tissue/cytology and plasma (circulating-free tumour-derived ct-DNA) samples; correlation between mutation status and demographic/disease status; treatment decisions; EGFR testing practices.
1458 pts enrolled; tissue/cytology evaluable: 1391; plasma evaluable:1421; Tissue/cytology EGFR mutation frequency (China): ADC:51.3% (526/1026); non-ADC: 11.1% (40/361); plasma generally lower. Mutation status concordance in 1355 matched samples: 77.6 % (95% CI 75.2–79.8); specificity: 97.1% (95.8–98.2); positive predictive value (PPV): 92.1% (88.3–94.9); negative PV: 73.6% (70.9–76.2). PPV in 606 samples tested with identical highly sensitive 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)
The IGNITE study shows that EGFR mutation testing should be considered in patients with NSCLC of adenocarcinoma and non-adenocarcinoma histology. And it further confirms the high frequency of EGFR mutation-positive status in Chinese patients with NSCLC and its strong correlation with adenocarcinoma histology, and never-smoking status. Plasma ctDNA may be used for patients where a tumour sample is not available / evaluable to determine EGFR mutation status.
Clinical trial identification
All authors have declared no conflicts of interest.