Noro R, Igawa S, Bessho A, et al. - Monotherapy with low-dose afatinib showed promising clinical efficacy and tolerability profile in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), and thus deserves to be one of the standard therapies for such cases.

• This was a multicenter, single-arm, open-label, phase II trial with 53 patients with EGFR positive NSCLC.

• Patients initially were administered afatinib 20 mg/day orally, and afatinib dose was increased (10 mg increments) for patients in whom the tumor progressed within stable disease.

• Median progression-free survival (PFS), and overall survival were 12.6 months, and not reached, respectively.

• The primary endpoint of PFS was met.

• Objective response rate and disease control rate of 66.0% and 92.5%, respectively, were obtained.

• Lower rate of adverse events was noted relative to that reported in previous phase III studies of 40 mg afatinib.