Abstract: Objective 　To evaluate the efficacy and toxicity and long2term safety of Gefitinib with locally advanced or metastatic NSCLC. Methods 　From Sep 2003 to Mar 2005, seventy advanced NSCLC pa2 tient s were t reated with Gefitinib orally 250 mg once a day until disease progression or the occurrence of intolerable toxicity. Results 　The tumor objective response rate was 12. 9 %, and the disease cont rol rate was 57. 2 %. The median progression2f ree survival time was 4 months (1～21 months), and the median o2 verall survival time was 7 months (1～31 months) . The 12year survival rate was 40 %, the 22year survival rate was 17. 1 %. The t reatment responses related with sex, smoking status and pathological type ( P <0. 05), but did not with age, stage and t reatment history ( P > 0. 05) . The improvement rates of symp2 toms and QoL were over 50 %, the improvement time was 1 month. The most common drug2related ad2 verse event s were skin rash (40 %) and diarrhea (30 %), and most of them were grade Ⅰ～ Ⅱ. There was one patient died f rom interstitial lung disease. The rate of patient s who had used Gefitinib more than one year is 21. 4 %, and the rate of patient s using Gefitinib more than two year is 10 %, and there is no SAE. Conclusion 　Gefitinib is effective and safe in the t reatment of patient s with locally advanced or me2 tastatic NSCLC, which can relieve symptom and improve the QoL. It is deserved to investigate the long2 term and maintenance t reatment of Gefitinib.