A phase II trial of gefitinib monotherapy in pretreated patients with advanced non-small cell lung cancer not harboring activating EGFR mutations.

e19155 Background: Efficacy of gefitinib therapy strongly depends on epidermal growth factor receptor (EGFR)-mutation status in patients with non-small cell lung cancer (NSCLC). However, cumulative data from many clinical studies demonstrated that some patients with wild-type (WT) EGFR also responded to gefitinib and remained stable. The aim of this trial was to evaluate the efficacy and toxicity of gefitiinb in NSCLC patients who failed previous chemotherapy with WT EGFR tumors. Methods: Patients with advanced or recurrent NSCLC whose tumors have WT EGFR were eligible. Gefitinib (250 mg/day) was administered until disease progression or unacceptable toxicity occurred. The primary end point was disease control rate (DCR) at 8 weeks. Results: Eighty-five patients (53 men and 32 women; median age, 60 years; range, 30-86) were enrolled between October 2010 and May 2013. Seventy-four (87.1%) had adenocarcinoma, nine (10.6%) had squamous cell carcinoma. Forty-one patients (48.2%) were treated with gefitinib as...