【摘要】 目的总结表皮生长因子受体酪氨酸激酶抑制剂吉非替尼治疗91例晚期非小细胞肺癌患者的疗效、中位肿瘤进展时间(TTP)、中位生存期和毒副反应,分析与疗效、生存期可能相关的因素。方法91例化疗失败的晚期非小细胞肺癌患者,中位化疗周期数为6(1～17)周期,68例(74．7%)患者至少经过二线方案化疗,疾病仍进展；Ⅳ期76例(83．5%),其中42例(46．2%)至少有2个转移部位。口服吉非替尼剂量为250 mg/d。运用SPSS 11．5统计软件进行统计分析。结果全组客观有效率为20．9%(19/91),疾病控制率为63．7%(58/91),症状改善率为72．7%(40/55),ECOG评分稳定及改善为71．4%(65/91)。腺癌、至少接受二线方案化疗及出现皮肤毒性者与疾病控制率呈明显正相关(P值分别为0．04、0．02及0．00)。中位TTP 5．0个月(95%CI为3．26～6．74),中位随访7．5(1～18．5)个月,1年生存率为56．4%。目前仍存活56例(61．5%),其中29例(51．8%)仍处于疾病控制中,20例生存期已超过1年(12～18．5个月)。对生存有益的单因素为不吸烟、疾病控制、出现皮肤毒性及吉非替尼治疗过程中控制转移灶。经Cox回归分析发现,不吸烟、疾病控制是独立预后因素(P值分别为0．01和0．00)。毒副反应主要为Ⅰ、Ⅱ度皮肤毒性。结论靶向治疗药物吉非替尼对传统治疗失败的晚期难治性非小细胞肺癌患者有明显疗效,有改善症状及延长生存期作用,且耐受性好。更多还原

【Abstract】 Objective To investigate the efficacy,time to progression,survival time and toxicity of epidermal growth factor receptor(EGFR)-tyrosine kinase inhibitor Gefitinib(Iressa),a target therapy agent,in the treatment of advanced non-small cell lung cancer(NSCLC),and to analyze the factors affecting the efficacy and patients’ survival.Methods From Nov.2003 to May 2005,91 patients with advanced NSCLC who failed from previous first-line chemotherapy were treated by gefitinib in this trial with a median chemotherapy cycle of six.Sixty-eight of these 91 patients(74.7%)had received a second-line chemotherapy.Seventy-six(83.5%)of the 91 patients had stageⅣdisease,and 42(46.2%)had developed metastases at least two sites.Gefitinib was administered orally at a dose of 250 mg daily until disease progressed or severe toxicity developed.Clinical data were analyzed using chi-square test,Log-lank test,Cox regression and Kaplan-Meier survival analysis in SPSS 11.5.Results(1)Overall response rate was 20.9%(19/91)and the disease control rate(response and stable disease)was 63.7%(58/91). Patients’symptoms were improved in 72.7%(40/55),and ECOG score was improved or remained stable in 71.4%(65/91).The disease control rate of those who had adenocarcinoma,or received second-line chemotherapy or developed skin toxicity was significantly better than the other patients(P value=0.04, 0.02,0.00,respectively).(2)Median time to progress(TTP)was 5.0 months(95% CI 3.26-6.74). (3)Median following-up duration was 7.5 months(1-18.5months),and 1-year survival rate was 56.4%. Of the 56 patients(61.5%)who were still alive when following-up ended,29(51.8% )had stable disease,20 had survived more than one year(12-18.5 months).Non-smoker,stable diseases,skin toxicities,and controlled metastatic diseases during the treatment of gefitinib were the favorable factors affecting the survival(P value=0.00,0.00,0.00,0.01,respectively).(4)The main toxicity of gefitinib was gradeⅠorⅡskin toxicity.Conclusion Gefitinib,a target therapy agent which may be an alternative,is effective and tolerable in the treatment for advanced NSCLC patients who have failed in the first-line or even second-line chemotherapy.It can remarkablely improve the disease control rate and disease- related symptoms,and also prolong survival in the responders.更多还原