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目的 探讨氨柔比星治疗小细胞肺癌(SCLC)的疗效、毒性及患者的预后.方法 收集北京大学肿瘤医院胸部肿瘤内1科2008年11月至2013年4月接受氨柔比星治疗的31例SCLC患者,其中男21例,女10例,年龄32 ～ 75岁,氨柔比星采用静脉注射单药(40 mg/m2,第1～3天给药,间隔21 d)或联合顺铂(60 mg/m2,第1天给药,间隔21 d).一线化疗方案包括氨柔比星联合顺铂11例,依托泊苷联合铂类18例及其他方案2例;二线及以上方案包括氨柔比星20例,托泊替康14例及其他方案28例.分析临床特点与无疾病进展生存期和总生存期的关系.采用SPSS 16.0(统计分析软件16.0)软件进行统计分析.结果 氨柔比星联合顺铂和单药化疗的中位无疾病进展生存期分别为7.5个月(95％ CI为6.2～8.8)和4.1个月(95％ CI为1.2 ～7.0,P=0.090).一线化疗后3个月内进展的难治性患者16例,3个月以上进展的敏感性患者15例,中位总生存期分别为14.2个月(95％ CI为11.1 ～17.3)和21.3个月(95％ CI为15.7 ～26.9,P=0.018).一线化疗氨柔比星联合顺铂与依托泊苷联合铂类方案的中位无疾病进展生存期分别为7.5个月(95％ CI为6.2 ～8.8)和4.6个月(95％ CI为1.7 ～7.5,P=0.055).二线及以上接受氨柔比星、托泊替康或其他方案化疗的中位无疾病进展生存期分别为4.1个月(95％ CI为1.2 ～7.0)、1.4个月(95％ CI为0.8 ～2.0)和1.6个月(95％ CI为1.2 ～1.9,P=0.013),在难治性患者中分别为5.6个月(95％ CI为2.0 ～9.2)、1.4个月(95％ CI为0.6～2.2)和1.4个月(95％CI为0.8 ～2.0).结论 氨柔比星单药作为SCLC二线及以上治疗方案安全有效,对难治性患者治疗效果较好,提示其或可成为难治性SCLC优选药物之一.“,”Objective To evaluate the response,toxicity and prognostic factors of amrubicin in the therapy of small cell lung cancer (SCLC).Methods Thirty-one SCLC patients treated with amrubicin in Beijing Cancer Hospital from Dec.2008 to Apr.2013,including 21 males and 10 females,aged from 32 to 75 years,were enrolled in this study.Amrubicin was injected intravenously with 40 mg/m2 d1-3,Q21 d or combined with cisplatin 60 mg/m2 d1,Q 21 d.The first line chemotherapy regimens included amrubicin plus cisplatin in 11 cases,etopside plus platin in 18 cases and other drugs in 2 cases.The second and more line chemotherapy treatments included amrubicin in 20 cases,topotican in 14 cases and others in 28 cases.SPSS 16.0 statistical analysis software was used to analyze the clinical characteristics and survivals.Results The median progression free survival (PFS) of patients receiving amrubicin plus cisplatin and single amrubicin were 7.5 months (95％ CI:6.2 to 8.8) and 4.1 months (95％ CI:1.2 to 7.0) respectively (P=0.090).There were 16 refractory patients whose disease progressed within 3 months after first line chemotherapy and 15 sensitive patients who had tumor progression after more than 3 months; the median survival time (MST) were 14.2 months (95％ CI 11.1-17.3) and 21.3 months (95％ CI 15.7-26.9)respectively(P =0.018).Patients treated with amrubicin plus cisplatin as first line therapy had a prolonged median PFS compared with etopside plus platin,which were 7.5 months (95％ CI:6.2-8.8) vs.4.6 months (95 ％ CI:1.7-7.5) (P =0.055).Patients received amrubicin,topotican or other drugs as second or more line therapy had median PFS of 4.1 months (95 ％ CI:1.2-7.0),1.4 months (95 ％ CI:0.8-2.0)and 1.6 months (95％ CI:1.2-1.9) respectively (P =0.013),while the median PFS was 5.6 months (95％ CI:2.0-9.2),1.4 months (95％ CI:0.6-2.2) and 1.4 months(95％ CI:0.8-2.0) (P =0.005and 0.003)in refractory patients.Conclusions Amrubicin as second or more line treatment was shown to be an effective and safe drug for SCLC patients with a significant survival benefit compared with other drugs,especially in refractory patients.It suggested that amrubicin might be one of the preferred therapies for refractory SCLC.