厄洛替尼治疗复治晚期非小细胞肺癌的临床分析

The evaluations of advanced non-small cell lung cancer patients treated with erlotnib

背景与目的:近年来,作为新的分子靶向药物-特罗凯(OSI774,Tarceva,厄洛替尼)在肺癌中得到越来越多的运用,并取得了可喜的成果。观察晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者接受厄洛替尼(erlotnib;商品名:特罗凯,OSI774,tarceva,)治疗后的近期疗效与毒副作用。方法:分析2005年12月-2006年9月上海市胸科医院肺部肿瘤临床医学中心40例接受特罗凯EAP(Expanded Access Program)项目慈善供药口服治疗复治的晚期NSCLC患者的疗效与毒副反应。结果:39例可评价的患者中位生存期(MST)为10.17个月(95%CI,6.98～13.35);无疾病进展时间(PFS)为7.83个月(95%CI,5.36～10.30)。不同程度皮疹的患者在PFS之间差异具有显著性(P=0.026)。所有患者中PR8人(20.51%),SD22人(56.41%),PD9人(23.08%)。(CR+PR)缓解率为:20.51%;疾病控制率(CR+PR+SD):76.92%。Fisher'精确检验提示在疾病控制率方面,女性优于男性(94.44%vs.61.90%,P=0.023);不吸烟患者优于吸烟患者(91.67%vs.53.33%,P=0.015);出现皮疹患者优于无皮疹患者(P=0.006)。影响缓解率与疾病控制率的多因素分析提示年龄(P=0.035)是影响疾病控制率的独立因素。最常见的毒性反应为皮疹与腹泻,大部分为0～Ⅰ度,不需要特别处理。结论:特罗凯有效治疗复治、晚期NSCLC患者。

Background and purpose：In the past several years, the compound that target EGFR signaling- erlotinib （Tarceva ） have made a significant impact on the treatment of non-small cell lung cancer （NSCLC）.To evaluate the efficacy of Tarceva on Chinese patients with advanced non-small cell lung cancer （NSCLC）. Methods：From Dec 2005 to Sep 2006, 40 advanced NSCLC patients were retrospectively reviewed. All patients had received Tarceva 150 mg/d. Survival curves were plotted by Kaplan-Meier method and compared by log-rank test. Univariate analysis of the patient characteristic and response rates and disease control rates was done by x2 test. Logistic regression was used for multivariate analysis. All reported Ps are two-sided and statistical significance was defined as P〈0.05.Results：Among the 40 patients, 8 patients got partial response（20.51%）,12 stable disease（56.41%）,and 9 progressive disease（23.08%）.The total response rate was 20.51% and disease control rate including both tumor response and stable disease was 76.92%.Median overall and progression-free survival times were 10.17month （95%CI,6.98-13.35）and 7.83 month （95%CI,5.36-10.30）. Age was the only independent variable in predicting disease control.The main toxicity of Tarceva was skin toxicity（rash） and diarrhea with no need of further treatment.Conclusions：Tarceva demonstrates significant antitumor activity and a favorable tolerability profile in this series of NSCLC patients.