[Efficacy of first-line afatinib versus chemotherapy in EGFR mutation positive pulmonary adenocarcinoma].

Therapy of patients with advanced NSCLC has lately changed due to the algorithm based on the presence or absence of oncogenic mutations. There is an agreement nowadays that in the presence of activating EGFR mutations, the administration of EGFR TKI (gefitinib, erlotinib, afatinib) is the most efficacious initial treatment. Unlike the first-generation TKIs, afatinib is a new, irreversible ErbB blocker, selectively and effectively blocking signals from the ErbB family receptors. Afatinib's marketing authorization is based on a large, randomized, phase III clinical trial, LUX-Lung 3, where patients in the control arm were treated with the best available chemotherapy (pemetrexed/cisplatin combination). Primary endpoint was progression-free survival (PFS). Patients with common EGFR mutations showed a PFS of 13.6 months when treated with afatinib, while treatment in the control arm resulted in a PFS of 6.9 months. Overall survival (OS) was 31.6 and 28.2 months, respectively. LUX-Lung 3 has been followed by the LUX-Lung 6 trial, comparing afatinib treatment to traditional chemotherapy (gemcitabine/cisplatin) in Asian patients with NSCLC harboring EGFR mutations. This clinical trial has also proved benefit of afatinib: PFS was 11.0 months in the afatinib arm and 5.6 months in the control arm by independent reviewer, while OS was 23.6 months and 23.5 months, respectively. Similarity of the OS values in both trials is explained by the cross-over treatment. When further analyzing OS data, a statistically significant difference between the afatinib and the control arm was seen in the EGFR exon 19 del subgroup (LUX-Lung 3: 33.3 vs. 21.1 months, LUX-Lung 6: 31.4 vs. 18.4 months, respectively).