TY - JOUR TI - An observational study to assess the molecular epidemiology and direct medical costs of epidermal growth factor receptor (Egfr) mutations in patients with advanced egfr mutation-positive non-small cell lung cancer treated with afatinib in real-world clinical settings in Greece AU - Mountzios, G. AU - Lampaki, S. AU - Koliou, G.-A. AU - Vozikis, A. AU - Kontogiorgos, I. AU - Papantoniou, P. AU - Koufaki, M.I. AU - Res, E. AU - Boutis, A. AU - Christopoulou, A. AU - Pastelli, N. AU - Grivas, A. AU - Aravantinos, G. AU - Lalla, E. AU - Oikonomopoulos, G. AU - Koumarianou, A. AU - Spyratos, D. AU - Bafaloukos, D., Snr AU - Rigakos, G. AU - Papakotoulas, P. AU - Fountzilas, G. AU - Linardou, H. JO - Lung Cancer: Targets and Therapy PY - 2021 VL - 12 TODO - null SP - 93-102 PB - Dove Medical Press Ltd SN - null TODO - 10.2147/LCTT.S318007 TODO - null TODO - Purpose: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are the preferred first-line option for patients with advanced, EGFR-mutant non-small cell lung cancer (NSCLC). Afatinib, a second-generation irreversible EGFR-TKI, has been exten-sively used in Greece in this setting; however, real-world data regarding molecular epidemiology and financial implications of afatinib use are lacking. Materials and Methods: This was an observational, non-interventional, multicenter, retro-spective cohort study, based on real-world data collected from the medical charts/records of patients treated with afatinib between 15/03/2015 and 25/06/2020 and were recorded on a web-based data capture system. Cox models were used to assess the prognostic significance of clinicopathological parameters with respect to clinical outcomes of interest. Cost analysis was conducted from a public third-payer perspective, and only direct medical costs reim-bursed by the payer were considered. Results: A total of 59 patients were treated with afatinib for their EGFR mutation-positive advanced NSCLC; the median age was 61 years (range: 37–91). Performance status was zero in 61%, and brain metastases were present in 13.6%. Forty-four patients (74.6%) had a deletion in exon 19 only, while nine (15.3%) had a mutation in exon 21, 8 of them in L858R and one in L861Q. At a median follow-up of 41.8 months (95% CI 35.9–51.4), the median PFS was 14.3 months (95% CI 12.2–16.4), and the median OS was 29 months (95% CI 25.6–33.4). Corresponding values for patients with deletion 19 only were 14.3 months (95% CI 11.5–18.5) and 28.1 months (95% CI 21.1–32.6), respectively. The mean expendi-ture for the treatment of each patient equals €25,333.68; with €21,865.06 being attributed to drug acquisition costs, €3325.35 to monitoring costs and €143.27 to adverse event treatment-related costs. Conclusion: Long-term data in the real-world setting in Greece confirm activity, tolerability and cost-effectiveness of afatinib as first-line treatment of patients with advanced EGFR-mutant NSCLC. Clinical Trial Registration: Clinicaltrials.gov NCT04640870. © 2021 Mountzios et al. ER -