Cl inical Study of Gef itinib in Treatment for Patients with Advanced Non2small Cell Lung Cancer

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.