吉非替尼治疗女性晚期复治NSCLC的临床研究  

Phase Ⅱ trial of gefitinib in female patients with previously treated advanced non-small cell lung cancer

作　　者：吴东平[1] 徐农[2] 方维佳[2] 张晓琛[2] 陈敬[2] 钱炯[2] 

机构地区：[1]绍兴市人民医院放疗科,浙江绍兴312000 [2]浙江大学医学院附属第一医院化疗科,浙江杭州310003

出　　处：《实用肿瘤杂志》2011年第2期187-190,共4页Journal of Practical Oncology

摘　　要：目的评价吉非替尼治疗女性晚期复治非小细胞肺癌的疗效和安全性。方法 32例患者接受口服吉非替尼250 mg/d治疗,直至病情进展或不能耐受。中位给药时间11.8月(2-52月)。结果随访至2010年1月1日,中位随访期20.2月,死亡19例,进展4例。32例患者CR 1例(3.1%),PR 19例(59.4%),SD 11例(34.4%),PD 1例(3.1%)。客观有效率为62.5%,疾病控制率为96.9%;无进展生存期(PFS)13.0月,1年无进展生存率50.9%,2年无进展生存率33.4%;中位生存期24.0月,1年生存率80.3%,2年生存率46.2%,3年生存率27.7%。与药物相关的毒副反应依次为皮疹27例(84.4%),腹泻15例(46.9%),食欲缺乏6例(18.8%),乏力5例(15.6%)。结论吉非替尼治疗女性晚期复治非小细胞肺癌有效,不良反应低。性别是晚期肺癌选择药物治疗及判断预后、疗效的一个重要临床因素,对于晚期、复治的女性非小细胞肺癌,可选择吉非替尼治疗。Objective To evaluate the efficacy and safety of gefitinib in female patients with previously treated advanced non-small cell lung cancer（NSCLC）.Methods Thirty-two female patients with NSCLC,who were previously treated with one or two chemotherapy regimens（at least one containing platinum）,were enrolled in this phase Ⅱ trial.All patients received 150 mg oral doses of gefitinib once daily and the median treatment duration was 11.8 months（2-52 months）.Results At the close-out date of 1 January 2010,19 patients died and 4 progressed.Among 32 patients,there were 1 of complete response,19 of partial responses and 11 of stable diseases with the overall response rate of 62.5%.The disease control rate was 96.9%.The median progression free survival was 13.0 months,and median overall survival time was 24 months.The 1-,2-and 3-year survival rates were 80.3%,46.2% and 27.7%,respectively.The main toxicities included rash（84.4%）,diarrhea（46.9%）,anorexia（18.8%） and fatigue（15.6%）.Conclusion Gefitinib is effective and well tolerated in female patients with previously treated advanced non-small-cell lung cancer.

关 键 词：癌 非小细胞肺/药物疗法 喹唑啉类/治疗应用 生存率 

分 类 号：R734.2[医药卫生—肿瘤]