国产多西紫杉醇治疗非小细胞肺癌的Ⅱ期临床研究

目的 :评价国产多西紫杉醇 (艾素 ,江苏恒瑞医药股份有限公司产品 )单用以及艾素 +顺铂联合化疗方案对非小细胞肺的临床疗效和安全性 ,并以进口多西紫杉醇 (泰索帝 ,安万特公司产品 ) +顺铂联合化疗方案作对照。方法 :患者随机分入艾素单用组 (A组 ) :艾素 75mg/m2 ;艾素 +顺铂组 (B组 ) :艾素 75mg/m2 +顺铂 75mg/m2 ;泰索帝 +顺铂组 (C组 ) :泰索帝 75mg/m2 +顺铂 75mg/m2 ;3组均为每 3周重复。结果 :入组的 115例中 10 4例可评价疗效 ,A、B和C组有效率分别为 8 10 %、2 3 5 3%、2 7 2 7%。B和C组有效率相似。不良反应主要有中性粒细胞减少、贫血、粒细胞减少性发热、其他发热、脱发、恶心呕吐和乏力。C组中性粒细胞减少的发生率高于B组 ,两组间差异有显著性 (P <0 0 5 )。其余不良反应两组相似。结论 :国产多西紫杉醇 (艾素 ) +顺铂与进口多西紫杉醇 (泰索帝 ) +顺铂两联合化疗方案相似 ,对非小细胞肺癌有一定疗效 ,且毒性可耐受。

Phase Ⅱ clinical trial on docetaxel in the treatment of non-small-cell lung cancer

Purpose:To investigate the efficacy and safety of docetaxel and two docetaxel plus cisplatin regimens in patients with non-small-cell lung cancer (NSCLC).Methods:Patients with NSCLC were randomly assigned to receive single-agent docetaxel (AISU) every 3 weeks (A);docetaxel (AISU) 75 mg/m 2 plus cisplatin 75 mg/m 2 every 3 weeks (B);docetaxel (Taxotere) 75 mg/m 2 plus cisplatin 75 mg/m 2 every 3 weeks (C). Results:104 of 115 patients were evaluable for efficacy. Overall response rates of A,B and C were 8.10%,23.53% and 27.27%, respectively. Response with B was similar to C. The major toxicities were neutropenia,anemia,febrile neutropenia,fever,alopecia,nausea,vomiting and fatigue. Neutropenia was more common with C than with B ( P <0.05). Conclusions:Two docetaxel plus cisplatin regimens are an effective and well-tolerated treatment in patients with NSCLC.