First-line gefitinib for poor PS patients with EGFR mutations

Abstract

8070 Background: We had previously reported several phase II studies using good performance status (PS) patients (pts) with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations (JCO, 2006:24, 3340, BJC, 2006:95, 998, and 1483). This phase II study was undertaken to investigate the efficacy and feasibility of gefitinib for poor PS pts with EGFR mutations. Methods: The peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method (PNA-LNA PCR clamp) can detect EGFR mutations using cytology specimens such as sputum and pleural effusion (Cancer Res, 2005;65:7276). Chemonaive advanced NSCLC pts with poor PS and EGFR mutations examined by the PNA-LNA PCR clamp were enrolled and received gefitinib (250 mg/day) alone. The response rate, progression-free survival, overall survival, PS improvement rate and toxicity profile were assessed prospectively. Sample size was decided to be > 25 pts to show the lower limit of 90% confidence interval (CI) > ...