吉非替尼单药治疗晚期非小细胞肺癌的疗效与安全性  

Evaluation of efficacy and safety of ZD1839 as monotherapy in Chinese patients with advanced nonsmall cell lung cancer

作　　者：王孟昭[1] 李龙芸[1] 王淑兰[1] 张晓彤[1] 钟巍[1] 张力[1] 李俊蓉[1] 

机构地区：[1]中国医学科学院中国协和医科大学北京协和医院呼吸科,100730

出　　处：《中华内科杂志》2008年第4期291-295,共5页Chinese Journal of Internal Medicine

摘　　要：目的探讨吉非替尼治疗晚期非小细胞肺癌（NSCLC）的疗效与安全性。方法分析2002年10月-2006年4月在北京协和医院呼吸科接受吉非替尼（250mg／d）治疗的晚期NSCLC患者的临床资料，用Kaplan-Meier方法计算中位生存期，用多因素Cox回归法分析不同因素对生存期的影响。结果（1）共入选204例患者，中位生存期为16．3个月（95％CI14．5—18．2个月）。1年生存率为57％。疾病客观有效率、稳定率分别为31．4％、41．7％。（2）未接受过化疗的26例患者的中位生存期16．0个月（95％CI13．7—18．3个月），接受过化疗的人群中位生存期16．5个月（95％CI14．2～18．8个月），差异无统计学意义（P=0．758）。（3）204例患者中142例患者疾病进展，进展后58例停止服药，84例继续服药至死亡或仍在服药，2组的生存期分别为19．9个月（95％CI13．1—26．7个月）、16．4个月（95％CI14．2～18．6个月），差异无统计学意义（P=0．534）。（4）多因素Cox回归分析显示，ECOG体能评分、病理类型、吉非替尼的客观疗效、化疗后复发、呼吸困难的变化与生存期明显相关。客观有效率与患者年龄、吸烟状况、病理类型、呼吸困难变化、皮疹显著相关。（5）不良反应一般较轻（1度或2度），停药后可逆。最常见的不良反应为皮疹72．6％（138／190）、腹泻33．7％（64／190）。结论晚期NSCLC患者接受吉非替尼治疗的耐受性好，对化疗失败的患者可明显延长生存时间。Objective To report the outcome of gefitinib for Chinese patients with advanced nonsmall cell lung cancer（NSCLC） at Peking Union Medical College Hospital. Methods From Oct. 2002 to Apr. 2006, 204 patients with advanced NSCLC received oral ZD1839 （250 mg/d） treatment. The were 110 （59. 9% ） men and 94 （40. 1% ） women aged between 25 and 85 years. Thirty-two patients had squamous cell carcinoma, 125 adenocarcinoma, 30 bronchoalveolar carcinoma or adenocarcinoma with partial bronchoalveolar carcinoma, 6 adenosquamous carcinoma, and 11 unspecified. Twenty-six patients had no history of chemotherapy, 62 had no disease progression after chemotherapy, and 111 failed to prior one or more regimens. Median survival was calculated using the Kaplan-Meier method and a Cox regression analysis was used to detect differences in median survival between strata. Results The median survival of all patients and of patients failed to prior chemotherapy were 16. 3 months （95% confidential interval CI, 14. 5 - 18.2） and 12. 5 months （95% CI 9.3 - 15.7）. The rate of 1-year survival was 57%. The objective tumor response rate and stable disease rate were 31.4% and 41.7% respectively. The median survival were significantly related with ECOG scores, pathology types, disease progression after chemotherapy, objective efficacy of gefitinib and changes of short-breathing. Among 26 patients with no prior chemotherapy, the median survival was not statistically significant compared with that of other patients. Among the enrolled patients, 111 had disease progression and 62 had stable disease after prior chemotherapy, and their median survivals was statistically different. At the time of this analysis, 142 patients had disease progression, 58 of whom withdrew from taking gefitinib, and 84 continued gefitinib therapy until death. The median survivals for these subgroups were not significantly different. Among 142 patients with disease progression, 40 received other systemic treatment, the median survival was statistically sign

关 键 词：癌 非小细胞肺 吉非替尼 治疗结果 安全 

分 类 号：R686[医药卫生—骨科学]