【摘要】 背景与目的:多西他赛(多西紫杉醇,进口药泰索帝,TXT)单药是晚期非小细胞肺癌二线治疗的标准治疗。本研究探讨多西他赛联合异环磷酰胺(IFO)方案与多西他赛单药治疗晚期非小细胞肺癌的疗效和不良反应。方法:随机对照研究56例非小细胞肺癌病例。共设立两组,T组:多西他赛单药方案;TI组:多西他赛联合异环磷酰胺方案。结果:PR:T组6例(23.0%);TI组7例(23.3%)。NC:T组9例(34.6%);TI组14例(46.7%)。PD:T组8例(30.8%);TI组8例(26.7%)。NE:T组3例(11.5%);TI组1例(3.3%)。两组相比,差异无显著性(P=0.6425)。1年生存率:T组21.2%;TI组22.0%。中位生存期:T组237.0 d;TI组226.0 d。两组相比,差异无显著性(P=0.8815)。中位肿瘤进展时间:T组157.1 d;TI组69.8 d。差异有显著统性(P=0.0039)。T组Ⅲ/Ⅳ度血小板减少为53.8%,TI组为16.7%,差异有非常显著性(P=0.0056)。T组Ⅲ/Ⅳ度中性粒细胞减少为65.4%,TI组为33.3%,差异有显著性(P=0.0137)。结论:多西他赛联合异环磷酰胺方案在非小细胞肺癌二线治疗中是安全、有效的,但是与多西他赛单药方案比较,有效率和生存期差异均无显著性。更多还原

【Abstract】 Background and purpose:The gold standard in second-line treatment of the advanced non-small-cell lung cancer which has proven activity in a randomized trial remains docetaxel.In this study we evaluated the overall response and side effects of docetaxel-ifosfamide regimen and docetaxel regimen in the treatment of advanced non-small-cell lung cancer.Methods:56 patients with non-small-cell lung cancer were randomized in the clinical trial.There were two arms.The patients in T arm received docetaxel single-agent and in TI arm docotaxel-ifosfamide regimen.Results:Only in 23.0% in the T arm and 3% in the TI arm were partial responses observed.Nine patients(34.6%) had stabilized disease in the Tarm and 14 patients(46.7%) in the TI arm.There was no significant statistical difference(P=0.6425).The 1-year survival rates were 21.2% in the T arm and 22.0% in the TI arm.Median survival for the patients in the T arm was(237.0) days and 226.0 days in the TI arm(P=0.0039).Grade Ⅲ/Ⅳ thrombocytopenia was 53.8% in the T arm and(16.7%) in the TI arm(P=0.0056).Grade Ⅲ/Ⅳ neutral leucopenia was 65.4% in the T arm and 33.3% in the TI arm(P=(0.0137)).Conclusions:Non-platinum regimens such as docetaxel-ifosfamide could be used as second line treatment for the patients with advanced non-small-cell lung cancer,they have demonstrated efficacy and safety.There are no significant differences in terms of response rates and survival in docetaxel-ifosfamide doublet and docetaxel single agent.更多还原