Abstract
We evaluated the real-world efficacy and side effects of afatinib as a first-line therapy for advanced EGFR mutation-positive lung adenocarcinoma. The medical records of patients receiving afatinib as a first-line therapy after National Health Insurance reimbursement between May 2014 and January 2016 were reviewed, and information on patient characteristics and treatment courses were collected consecutively. Rebiopsy tissue was collected for EGFR mutation and MET amplification analyses. MET amplification was detected by fluorescence in situ hybridization and immunohistochemistry. In total, 140 patients were enrolled (median follow-up, 18.0 months). No significant differences in side effects, treatment responses, progression-free survival, or brain metastasis control were observed between patients receiving 40 mg versus < 40 mg of afatinib during the first 6 months. Patients with significant pretreatment weight loss (> 10.0% in 6 months) had a shorter median progression-free survival. Patients with brain metastases had a poorer Eastern Cooperative Oncology Group performance status and were associated with a shorter median progression-free survival. Nine patients (32.1%) had a p.T790M mutation and only 1 patient gained MET amplifications after disease progression. Afatinib is effective as a first-line therapy for advanced EGFR mutation-positive lung adenocarcinoma. Afatinib dosage does not affect clinical efficacy and drug-related side effects.
Highlights
Lung adenocarcinoma, the major histological subtype of non-small cell lung cancer, has been further subclassified into several molecular subsets with susceptibility to specific ‘‘targeted’’ drugs as advances have been made in translational research
The use of first-generation EGFR-TKIs as a first-line therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma has been associated with a higher objective response rate (ORR) and longer progression-free survival (PFS) than platinum-based doublet chemotherapy [5, 6]
In a subsequent phase IIB trial (LUX-Lung 7 [12]) afatinib conferred a significant benefit in prolonging PFS and time to treatment failure, but not overall survival (OS), compared to first-line treatment with gefitinib in patients with advanced EGFR mutation-positive lung adenocarcinoma
Summary
The major histological subtype of non-small cell lung cancer, has been further subclassified into several molecular subsets with susceptibility to specific ‘‘targeted’’ drugs as advances have been made in translational research. Afatinib has proven to be effective as a first-line therapy in patients with advanced EGFR mutation-positive lung adenocarcinoma in the LUX-Lung 3 [10] and LUX-Lung 6 [11] trials. In these phase III trials [10, 11] afatinib was associated with a significantly prolonged PFS compared to first-line chemotherapy with cisplatin and pemetrexed or cisplatin and gemcitabine, respectively. In a subsequent phase IIB trial (LUX-Lung 7 [12]) afatinib conferred a significant benefit in prolonging PFS and time to treatment failure, but not overall survival (OS), compared to first-line treatment with gefitinib in patients with advanced EGFR mutation-positive lung adenocarcinoma
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