奈达铂治疗非小细胞肺癌的Ⅱ期临床研究报告

Phase Ⅱ Clinical Trial of Nedaplatin in Advanced Non-Small Cell Lung Cancer

背景与目的:观察奈达铂治疗晚期非小细胞肺癌(non-smallcelllungcancer,NSCLC)的疗效及不良反应。方法:本研究为多中心随机对照Ⅱ期临床研究。复治NSCLC病人进入奈达铂单药治疗组,奈达铂100mg/m2静滴,每3周重复。将初治病人(未接受过化疗)随机分组,试验组化疗方案为奈达铂联合VDS,对照组为DDP联合VDS。结果:共138例病人,其中化疗方案单药组复发病例16例,联合治疗试验组60例,联合治疗对照组62例。单药组病人,既往均接受了DDP或卡铂的治疗,仍然有12.5%的有效率;治疗组与对照组的疗效基本接近,分别为26.7%与25.8%。在不良反应方面,贫血及白细胞下降发生率,奈达铂组与DDP组基本一致,而血小板的抑制率,奈达铂组则明显高于顺铂组,且严重的血小板下降在奈达铂组中有较高的发生率。奈达铂可致轻度恶心、呕吐。结论:奈达铂对晚期的NSCLC有一定的疗效,对于顺铂或卡铂耐药的NSCLC病人,奈达铂仍有一定的有效率。奈达铂单药或联合治疗临床可耐受,不良反应主要为骨髓抑制,特别是血小板下降。

Background & Objective: The aim of this study was to observe the efficacy and the side effects of nedaplatin in treatment of non small cell lung cancer (NSCLC). Methods: This is a multi center phaseⅡ clinical trial. The previously chemotherapy treated patients with NSCLC were administrated nedaplatin alone. Nedaplatin was given at 100 mg/m2,iv,repeated every 3 weeks. The chemonaive patients with NSCLC were randomized to two groups. The combination trial group was given with nedaplatin+vindesine regimen, and the combination control group with cisplatin+vindesine. Results: Of 138 patients,16 were in the nedaplatin single drug group; 60 were in the combination trial group;and 62 were in the combination control group. All of the 16 cases in the single drug group, which were treated with platinum previously, achieved 12.5% of response rate. And the combination trial group and control group had a very similar response rate, which were 26.7% versus 25.8%, respectively. The incidence rates of neutropenia and anemia were similar in the two groups. But the incidence rate of thrombocytopenia was higher in the trial group than that in the control group. Nedaplatin has a possibility to result in mild nausea/vomiting. Conclusion:Nedaplatin is an effective platinum drug in the treatment of NSCLC,not only for no previously chemotherapy patients,but also for those patients resistant to cisplatin/carboplatin. Nedaplatin has a good clinical tolerance. And the main adverse reaction was myelosuppression, especially thrombocytopenia.