Abstract: Objective:To investigate the efficacy and toxicity of Gefitinib as the first-line therapy in elderly patients with non-small cell lung cancer (NSCLC). Methods:Clinical data of 28elderly patients with advanced NSCLC administered oral Gefitinib (250 mg/d) as first-line therapy, who were admitted to our hospital during the period from June 2005to September 2008, were analyzed. The focus point in the study included the median overall survival (OS), progression-free survival (PFS), response rate and toxicity. Results: No complete regression (CR) was seen in our cases. Partial response (PR) and stable disease (SD) were respectively found in 10(35.7% ) and14(50.0% ) patients. The median PFS was 6.5 months (95% CI, 3.9-9.0 m) and OS was 12.8 months (95% CI, 6.3-19.3 m) in all the patients. The1-year survival rate was achieved by 53.6% (16/28). Adverse reactions were mild and reversible, and most reactions were at grade I to II. Grade-Ⅲ rash and diarrhea were respectively seen in 2 and 1 patients, with relief after symptomatic treatment. Conclusion:Our study suggests that Gefitinib as the first line therapy in the elderly non-small cell lung cancer patients has satisfactory curative effects, with a better drug tolerance.