每周单药国产多西它赛方案与每周国产多西它赛联合铂类方案治疗晚期非小细胞肺癌的临床研究

Clinical study on weekly docetaxel alone or combination with cisplatin regimens in the treatment of advanced non-small cell lung cancer

目的观察单药每周国产多西它赛方案与每周国产多西它赛联合顺铂方案治疗老年晚期非小细胞肺癌的客观疗效及毒副反应。方法156例患者非随机分为两组，A组82例患者采用国产多西它赛每周21—29mg／m^2（中位剂量为每周25mg／m^2），静脉滴入，连用6周休2周；B组74例患者使用国产多西它赛方法及剂量同上，同时于第1—3天分别给予顺铂30mg／m^2，静脉滴入，所有患者均接受8周以上的化疗。结果156例患者可评价疗效，A组38例患者达PR，有效率为46．3％（38／82），中位生存期为13．1个月，1年生存率为48．0％；B组36例患者达PR，有效率为48．6％（36／74），中位生存期为12．6个月，1年生存率为51．0％。两组主要毒副反应为恶心呕吐和腹泻、肝功能损害、骨髓抑制、皮疹等，A组患者毒副反应较B组轻，两组患者耐均受良好。经常规预防用药后，未观察到过敏反应、疲乏、浮肿现象。结论每周单药国产多西它赛疗法与每周国产多西它赛联合铂类方案治疗非小细胞肺癌疗法疗效相当，且毒副反应轻，临床使用安全，值得临床进一步研究。

Objective To investigate the efficacy and side effects of weekly docetaxel alone and weekly docetaxel combined with cisplatin regimens in treatment of patients with advanced non-small cell lung cancer（NSCLC）. Methods 156 Patients with advanced NSCLC were divided non-randomly into groups A and B. Eighty-two cases in A group were administrated weekly with docetaxel 21- 29 rag/m^2 by intravenous infusion（iv） ,with median dose being 25 rag/m^2. Each cycle consisted of 6 weeks of therapy ,followed by 2 weeks of treatment break. The administration method and dose of docetaxel for group B were same as those for group A. Cisplatin 30 rag/m2 was given on d1-3, iv. All patients received at least 8 weeks of chemotherapy. Results Thirty-eight patients in group A had partial response, with the objective response rate being 46.3%. The median survival time was 13.1 months, with one-year survival rate being 48%. Thirty-six patients in group B had partial response, with the objective response rate being 48.6%. The median survival time was 12.6 months ,with one-year survival rate being 51.0%. The major toxic reactions included nausea, vomiting and diarrhea, liver function impairment, myelosuppression and skin eruption. These reactions were milder in group A than in group B and were tolerable. After preventive treatment, no severe hypersensitivity reaction,edema and fatigue were observed. Conclusion Weekly docetaxel alone and docetaxel combined with cisplatin regimens have same efficacy and are safe in treating patients with advanced non-small cell lung cancer,with mild to moderate side effect . Further clinical investigation is warranted.