Real world data of efficacy and safety of erlotinib as first-line TKI treatment in EGFR mutation-positive advanced non-small cell lung cancer: Results from the EGFR-2013-CPHG study

Background. - Phase III clinical trials have demonstrated the merits of epidermal growth factor receptor( EGFR)-tyrosine kinase inhibitors (TKI) in the treatment of non-small cell lung cancer (NSCLC) patientswith EGFR-activating mutations. Using a cohort of unselected patients treated with erlotinib, we soughtto further describe patient and tumour characteristics, and to evaluate their progression-free survival( PFS) and overall survival (OS). Methods. - Overall, 44 pulmonologists included patients with the required characteristics as follows: Stage IIIB-IV NSCLC, EGFR-activating mutation, age = 18 years, and having to start erlotinib therapy orreceiving erlotinib therapy as the first-line TKI, regardless of treatment-line. The analyses were performedusing R software, with survival rates calculated according to the Kaplan-Meier method. Results. - A total of 177 patients, aged 72 years on average, were enrolled over a 2-year period. The cohortincluded 123 women (69.5%), 158 Caucasians (89.3%), 112 non-smokers (63.2%), and 167 adenocarcinomas (94.3%), at either stage IIIB (21) or IV (156), with a good performance status (PS 0-1, 127). Overall, 40exhibited brain metastases at baseline (22.6%), while 75 had undergone earlier treatment (42.4%). MedianPFS was 11.7 months and OS 25.8 months, with respectively a 1-year rate of 48.6% and 74%. The risk ofdeath correlated with ECOG status (PS = 2, HR = 4.48, P < 0.001) but not with brain metastasis (HR = 1.67, P = 0.278). Conclusions. - This study has confirmed erlotinib's efficacy and safety for unselected patients, with PFSand OS comparable to those obtained in phase III trials.