Afatinib as first-line treatment for patients with advanced non-small-cell lung cancer harboring EGFR mutations: focus on LUX-Lung 3 and LUX-Lung 6 phase III trials

In patients with advanced or metastatic non-small-cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations, the use of EGFR tyrosine kinase inhibitor (TKI) showed to improve survival and safety profile, when compare with standard chemotherapy. These results were reported in different randomized clinical trials with erlotinib as EURTAC and OPTIMAL (1-3), and with gefitinib IPASS, NEJ002, First-SIGNAL and the West Japan Thoracic Oncology Group Study (3-6). In these studies the median progression-free survival was around 10-12 months. After the results of the IPASS trial, gefitinib was approved for advanced NSCLC with EGFR positive mutation in all setting of treatment in Europa and Asia; while erlotinib that received in 2005 the indication in second- and third-line treatment in patients unselected for EGFR mutations after the Br.21 trial, recently was approved by FDA for the first-line treatment in patients with NSCLC harboring EGFR mutations, based on the results of the EURTAC trial in Europe, Asia and USA.