Journal Article

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

Mountzios, Giannis, Aravantinos, Gerasimos, Grivas, Anastasios, Papantoniou, Panagiotis, Boutis, Anastasios, Christopoulou, Athina, Koufaki, Margarita-Ioanna, Lampaki, Sofia, Linardou, Helena, Fountzilas, George, Papakotoulas, Pavlos, Koliou, Georgia-Angeliki, Rigakos, Georgios, Pastelli, Nicoleta, Koumarianou, Anna, Spyratos, Dionisiοs, Lalla, Efthalia, Vozikis, Athanassios, Kontogiorgos, Ioannis, Res, Eleni, Oikonomopoulos, Georgios, Bafaloukos, Dimitrios

2021

Overview

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 extensively used in Greece in this setting; however, real-world data regarding molecular epidemiology and financial implications of afatinib use are lacking. This was an observational, non-interventional, multicenter, retrospective 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 reimbursed by the payer were considered. 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 expenditure 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. 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. Clinicaltrials.gov NCT04640870.

• Publisher: Dove Medical Press Limited,Taylor & Francis Ltd,Dove Press,Dove,Dove Medical Press
• Subject: Adverse events / afatinib / Biopsy / Brain cancer / Cancer therapies / Chemotherapy / Clinical medicine / Cost analysis / cost-effectiveness / Data entry / Drug dosages / EGFR / Epidemiology / Epidermal growth factor / epidermal growth factor receptor / epidermal growth factor receptor (egfr) / Epidermal growth factor receptors / Gene deletion / Genetic aspects / Lung cancer / Lung cancer, Non-small cell / Lung cancer, Small cell / Medical care, Cost of / Metastases / Metastasis / molecular epidemiol-ogy / molecular epidemiology / Mutants / Mutation / Non-pharmacological intervention / Non-small cell lung carcinoma / Observational studies / Original Research / Patients / Pharmaceutical industry / Protein-tyrosine kinase / Small cell lung carcinoma / Tyrosine