Phase II Study of Erlotinib in Japanese Patients with Advanced Non-small Cell Lung Cancer

The aim of this study was to evaluate the efficacy and safety of erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor, in Japanese patients with relapsed or recurrent advanced non-small cell lung cancer (NSCLC). This was a multicentre, open-label phase II study of erlotinib (150 mg/day) in patients with stage IIIB or IV NSCLC. The primary endpoint was the objective tumour response rate. Of the 46 patients, 13 were assessed to have a partial response and 9 had stable disease. The median duration of response was 449 days and time to progression was 75 days. Median overall survival (OS) was 13.5 months and the 1-year survival rate was 56.5%. The most common adverse events were dermal or gastrointestinal, and were mainly grade 2 or less. An exploratory analysis suggested a link between rash severity and OS. Erlotinib has promising antitumour activity and is generally well tolerated in Japanese patients with previously treated NSCLC.