吉非替尼治疗晚期非小细胞肺癌临床研究

 目的　评价吉非替尼( Gefitinib) 在晚期非小细胞肺癌患者中的疗效、不良反应和长期用药的安 全性。方法　2003 年9 月～2005 年3 月,70 例晚期非小细胞肺癌患者应用吉非替尼250 mg/ d ,直至肿 瘤进展或出现不可耐受的不良事件。结果　ORR 12. 9 % ,DCR 57. 2 % ,PFS 4 月(1～21 月) , TTD 7 月 (1～31 月) ,1 年生存率40 % ,2 年生存率17. 1 %。疗效与性别、吸烟状态、病理类型相关( P < 0. 05) ,与 年龄、分期、既往治疗史无关。治疗后症状改善率超过50 % ,改善时间在用药1 月内。不良事件为皮疹 (40 %) 和腹泻(30 %) ,大多数为CTC Ⅰ～ Ⅱ度,但有1 例因间质性肺病( ILD) 死亡。21. 4 %的患者维持 用药时间超过1 年,超过2 年的达10 % ,长期用药过程中没有出现严重不良事件。结论　吉非替尼疗效 较好,可明显改善晚期非小细胞肺癌患者的症状,提高生活质量,毒副反应轻,在长期维持治疗中的地位 值得深入研究。

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.