422PD - Local diagnostic practices for advanced non-small-cell lung cancer (NSCLC) in Chinese Patients: subset of the IGNITE study

Date 19 December 2015
Event ESMO Asia 2015 Congress
Session Thoracic cancers
Topics Non-Small-Cell Lung Cancer, Metastatic
Pathology/Molecular Biology
Presenter Baohui Han
Citation Annals of Oncology (2015) 26 (suppl_9): 125-147. 10.1093/annonc/mdv532
Authors B. Han1, C. Shi1, M. Wang2, Y. He3, Y. Zhang4, S. Tjulandin5, M. Ratcliffe6, R. McCormack6
  • 1Department Of Pulmonary Medicine, Shanghai Chest Hospital, 230032 - Shanghai/CN
  • 2Department Of Respiratory Medicine, Peking Union Medical College and Chinese Academy of Medical Sciences, Peking/CN
  • 3Department Of Respiratory Medicine, The Third Military Medical University, Chongqing/CN
  • 4Department Of Chemotherapy, Zhejiang Cancer Hospital and Key Laboratory Diagnosis and Treatment Technology on Thoracic Oncology, Hangzhou/CN
  • 5Department Of Clinical Pharmacology And Chemotherapy, Russian Cancer Research Center, Moscow/RU
  • 6Astrazeneca, Macclesfield, Alderley Park/GB

Abstract

Aim/Background

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.

Methods

Eligible patients: local/metastatic aNSCLC (chemotherapy-naïve, 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.

Results

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)

Conclusions

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

NCT01788163

Disclosure

All authors have declared no conflicts of interest.