Multicentre prospective phase II trial of gefitinib for advanced non-small cell lung cancer with epidermal growth factor receptor mutations: results of the West Japan Thoracic Oncology Group trial (WJTOG0403)

摘要: The purpose of this study was to evaluate the efficacy gefitinib and feasibility screening for epidermal growth factor receptor (EGFR) mutations among select patients with advanced non-small cell lung cancer (NSCLC). Stage IIIB/IV NSCLC, chemotherapy-naive or recurrences after up two prior chemotherapy regimens were eligible. Direct sequencing using DNA from tumour specimens performed by a central laboratory detect EGFR mutations. Patients harbouring received gefitinib. primary objective response; secondary objectives toxicity, overall survival (OS), progression-free (PFS), 1-year (1Y-S) disease control rate (DCR). Between March 2005 January 2006, 118 recruited 15 institutions screened mutations, which detected in 32 – 28 whom enrolled present study. response 75%, DCR 96% median PFS 11.5 months. OS has not yet been reached, 1Y-S 79%. Thus, NSCLC highly effective. This trial documents performing multicentre phase II typing laboratory, demonstrating benefit selecting treatment based on their mutation status.