Phase II study of the efficacy of gefitinib in patients with non-small cell lung cancer with the EGFR mutations

Abstract

7183 Purpose: Recent studies have indicated that the mutations of epidermal growth factor receptor (EGFR) were associated with sensitivity of non-small cell lung cancer (NSCLC) to gefitinib, an EGFR tyrosine kinase inhibitor. The clinical objective of this study was to prospectively evaluate the efficacy of gefitinib in patients with stageIII/IV NSCLC that had the EGFR mutations. Methods: Genomic DNA was extracted from tumor specimens and EGFR mutations in exon 19 and 21 were analyzed by direct sequencing. Patients with stageIII/IV NSCLC who had the EGFR mutations were treated with gefitinib (250mg) orally. Response, survival data and toxicity were assessed. Results: From Nov. 2004 to Dec 2005, 14 patients with the EGFR mutations received gefitinib (median age: 67 years; 2 males, 12 females; 1 smokers, 13 non-smokers; all adenocarcinomas). Two patients discontinued gefitinib and came off study because of interstitial pneumonitis (grade 3) and acne (grade 3), respectively. Response data are available for 12 patients. Two achieved a complete response (CR), seven exhibited a partial response (PR) and three had stable disease (SD). Response rate and disease control rate were 75% and 100%, respectively. There were no grade 3/4 toxicities in these 12 patients. All patients were alive during median follow-up period of 8 months (range 1–13 months). Conclusions: The EGFR mutations could be an excellent predictor of response to gefitinib in NSCLC. No significant financial relationships to disclose.