吉非替尼或多西紫杉醇二线治疗非小细胞肺癌临床研究

目的:观察吉非替尼（Iressa）与多西紫杉醇（艾素）单药二线治疗晚期非小细胞肺癌的疗效和不良反应。方法:98例经一线化疗失败的晚期非小细胞肺癌患者，随机分为吉非替尼组和多西紫杉醇组。吉非替尼组50例，口服 Iressa 250mg/次，1 次/天，直至疾病进展或出现不能耐受的不良反应；多西紫杉醇组 48例，应用艾素 75mg/m2，静脉滴注1h，第1 天，21天为1 个疗程，至少接受2 个疗程。按照RECIST实体瘤疗效评价标准进行疗效评价。结果:吉非替尼组（1 例服药1 个月后自动出组）有效率为22.4%（11/49），临床获益率为55.1%（27/49），中位生存时间为7.1 个月，1 年生存率为35.9% 。多西紫杉醇组有效率为18.8%（9/48），临床获益率为50.0%（24/48），中位生存时间为6.9 个月，1 年生存率为31.5% ，两组有效率、临床获益率、中位生存时间和1 年生存率差异均无统计学意义（P>0.05）。 吉非替尼组Ⅰ～Ⅳ度和Ⅲ～Ⅳ度皮疹发生率分别为51.0% 和10.2% ，明显高于多西紫杉醇组（P=0.000 0和P=0.029 6），其Ⅰ～Ⅳ度腹泻发生率亦明显高于多西紫杉醇组（P<0.01）；而多西紫杉醇组患者白细胞减少发生率明显高于吉非替尼组（P=0.000 0），血小板减少和贫血发生率仅Ⅰ～Ⅳ度高于吉非替尼组（P=0.000 0 和P=0.026 6）。生存质量改善率吉非替尼组高于多西紫杉醇组（P<0.01）。 结论:作为二线药物治疗晚期非小细胞肺癌，吉非替尼与多西紫杉醇相比，疗效相近，不良反应较轻，生存质量改善率更高，值得临床推广应用。 

Second-line Treatment with Gefitinib or Docetaxel for Advanced Non-small Cell Lung Cancer

Objective:To observe the efficacys and side effects of gefitinib(Iressa)and docetaxel(aisu)as the second-line treatment for advanced non-small cell lung cancer(NSCLC)patients.Methods:A total of 98 patients with advanced non-small cell lung cancer who had failed to previous fimt-line chemotherapy were randomly divided into two groups:gefitinib group and docetaxel group.In the gefitinib group,50 patients took Iressa 250 mg once daily until disease progression or intolerable toxicity occurred.In the docetaxel group,58 patients were treated with aisu 75mg/m~2 i.v.in 60 minutes in day 1.The regimen was repeated every 21 days for at least 2 consecutive cycles.They were assessed on the basis of RECIST evaluation standard of therapeutic effect for solid tumor.Results:In the gefitinib group,the response rate was 22.4%(11/49),the clinical benefit rate was 55.1%(27/49),median survival time was 7.1 months and 1-year survival rate was 35.9%.In the docetaxel group,the response rate,clinical benefit rate,median survival time and 1-year survival rate were 18.8%(9/48),50.0%(24/48),6.9months and 31.5%,respectively(P>0.05).The incidences of Ⅰ～Ⅳ degree and Ⅲ～Ⅳ degree rash were 51.0%and 10.2%in the gefitinib group,significantly lower than those in the docetaxel group (P=0.0000 and P=0.0296).The incidence of Ⅰ～Ⅳ degree diarrhea was significantly higher in the gefitinib group than that in the docetaxel group(P<0.01).The incidence of leukopenia was significantly higher in the docetaxel group than that in the gefitinib group(P=0.0000).The incidences of thrombocytopenia and anemia of Ⅰ～Ⅳ degree were also higher in the docetaxel group (P=0.0000 and P=0.0266).The improvement rate of quality of life was higher in the gefitinib group (P<0.05).Conclusion:Gefitinib has a similar anti-tumor effect as docetaxel on advanced NSCLC patients who have failed to previous fimt-line chemotherapy.Gefitnib can achieve higher improvement rate of quality of life in advanced NSCLC patients,with a lower incidence of toxicity.