论文部分内容阅读
目的:观察表皮生长因子受体酪氨酸激酶抑制剂吉非替尼(gefitin ib,Iressa)单药治疗晚期非小细胞肺癌的疗效和毒副反应。对象与方法:2003年9月~2005年5月期间,我科住院和门诊86例晚期非小细胞肺癌患者,给药方式为单药口服吉非替尼250 mg,1次/d。其中男性47例,女性39例;年龄22~86岁,中位年龄60岁;Ⅲ期14例,Ⅳ期72例。中位服药时间7个月,随诊率100%。应用方差分析、t检验、Kap lan-M e ier方法进行统计分析。结果:近期疗效,CR 1例(1.2%),PR 23例(26.7%),有效率(CR+PR)27.9%;SD 34例(39.5%),疾病控制率(CR+PR+SD)67.4%。症状改善率58.7%,中位症状改善时间10 d(1~14 d);中位症状缓解持续时间6.2个月。中位TTP为7.2个月;中位生存期8.5个月,1年生存率37.5%。主要不良反应为皮疹(54.6%)和腹泻(44.2%),大部分患者为轻度,Ⅲ~Ⅳ度不超过5%,经对症处理后均可缓解。其他反应包括恶心(10.5%)、憋喘(5.8%)、发热(2.3%)、间质性肺炎(1.2%)和结膜炎(1.2%)。多因素分层分析显示,近期疗效和生存在女性、腺癌、体力状态好、不吸烟、年龄≤65岁的患者中较好(P<0.05)。肿瘤组织中EGFR、p53及HER2的表达状况与吉非替尼治疗的近期疗效和生存无关(P>0.05)。结论:吉非替尼单药治疗晚期非小细胞肺癌疗效肯定,毒副反应较小,患者耐受性好。
Objective: To observe the curative effect and toxicity of epidermal growth factor receptor tyrosine kinase inhibitor gefitinib (Iressa) in the treatment of advanced non-small cell lung cancer. Subjects and Methods: From September 2003 to May 2005, 86 patients with advanced non-small cell lung cancer in our hospital and outpatient department were treated with single-agent gefitinib 250 mg once daily. Including 47 males and 39 females; aged 22 to 86 years old, the median age of 60 years; 14 cases of stage Ⅲ, 72 cases of stage Ⅳ. Median medication for 7 months, 100% follow-up rate. Analysis of variance, t test, Kaplan-Meier method were used for statistical analysis. Results: The short-term curative effect was as follows: CR 1 (1.2%), PR 23 cases (26.7%), effective rate (CR + PR) 27.9%, SD 34 cases (39.5%), disease control rate %. The improvement rate of symptoms was 58.7%, the median symptom improvement time was 10 days (ranged from 1 to 14 days), and the median symptom relief duration was 6.2 months. The median TTP was 7.2 months; the median survival was 8.5 months and the 1-year survival rate was 37.5%. The main adverse reactions were rash (54.6%) and diarrhea (44.2%). Most patients were mild and grade Ⅲ ~ Ⅳ did not exceed 5%. All patients were relieved after symptomatic treatment. Other reactions included nausea (10.5%), wheezing (5.8%), fever (2.3%), interstitial pneumonia (1.2%) and conjunctivitis (1.2%). Multivariate stratified analysis showed that the short-term efficacy and survival in women, adenocarcinoma, good physical condition, no smoking, age ≤ 65 years of patients better (P <0.05). The expression of EGFR, p53 and HER2 in tumor tissue was not related to the short-term efficacy and survival of gefitinib (P> 0.05). Conclusion: Gefitinib monotherapy in the treatment of advanced non-small cell lung cancer is positive, the side effects are small, and patients are well tolerated.