吉非替尼治疗晚期非小细胞肺癌的临床研究

The safety and efficacy of gefitinib in the treatment to advanced non - small cell lung cancer

目的探讨并观察表皮生长因子受体酪氨酸激酶抑制剂——吉非替尼（gefitinib，ZD1839，IRESSA）治疗晚期（Ⅲb、Ⅳ期）非小细胞肺癌（non—small cell lung cancer，NSCLC）的疗效和毒副反应。方法观察2004年2月至2006年3月期间笔者所在科收集的32例晚期NSCLC患者接受吉非替尼（250mg）顿服，直至病情进展或死亡或出现不可耐受的不良反应而终止治疗的情况。结果32例晚期NSCLC患者，无1例完全缓解（CR），19例部分缓解（PR），9例稳定（SO），4例进展（PD）；全组有效率（CR＋PR）为59．38％，疾病稳定率28．13％，临床获益率（CR＋PR＋SD）为87．5％。缓解最为明显的症状主要为咳嗽咳痰减轻，胸闷气短好转及疼痛减轻。中位生存期3．5个月，截至随访时间，62．5％的患者仍存活。其疗效与性别和既往吸烟史有显著相关性，女性疗效优于男性，无吸烟史者优于有吸烟史者；最常见的药物不良反应主要表现为Ⅰ、Ⅱ度皮疹（25％，9．38％）、腹泻（15．63％），不需特殊处理。结论吉非替尼对于晚期NSCLC患者，尤其是对于亚裔女性、腺癌、未吸烟患者能较好地缓解疾病相关症状，毒副反应轻微，大多可耐受，是一种安全、有效并具有较好耐受性的治疗药物。

Objective To summarize and observe the clinical results and toxicity of Gefitinib in the treatment to advanced non - small cell lung cancer（NSCLC）. Methods Thirty - two patients with unresectable IIIb or IV NSCLC who admitted to our hospital from February 2004 to March 2006 were included in the study. Gefitinib was oral administered 250 mg once daily until disease progression or the occurrence of intolerable toxicity. Results Among the 32 NSCLC, no complete response（CR） and 19 partial response（ PR）, The objective response rate （CR ＋ PR） was 59. 38%, stability disease rate was 28.13% and disease control rate （ CR ＋ PR ＋ SD） was 87.5%. The most effective symptoms was cough and pain. The median overall survival time was 3.5 months. 20 patients were even alive to the underlying time. The effect of Gefitinib was related to sexual and smoking. The effect of the female is better than male and non - smoking is better than smoking. The most common drug - related adverse events were grade Ⅰ or Ⅱ skin rash （25% , 9. 38% ） and diarrhea （ 15.63% ） with no need of further treatment. Conclusion Gefitinib is effective, safe and easy in treating patients espicially female, non - smoking and adenocarcinoma with locally advanced or metastatic NSCLC after failure of previous chemotherapy. It is tolerated by the patients and may remarkabley improve their symptoms and quality of life.