拓扑替康治疗小细胞肺癌Ⅱ期临床研究  

PhaseⅡ Clinical Study of Topotecan in Treatment of Patients with Small Cell Lung Cancer： A Multiple Center Clinical Trail

作　　者：张力[1] 夏忠军[1] 管忠震[1] 李佩文[2] 刘又宁[3] 胡小电[4] 周清华[5] 倪殿涛[6] 汪雪兰[7] 

机构地区：[1]中山医科大学肿瘤防治中心内科,广东广510060 [2]中日友好医院,北京100029 [3]解放军总医院,北京100853 [4]军事医学科学院附属医院,北京100039 [5]华西医科大学第一附属医院,陕西西安610041 [6]第四军医大学西京医院,陕西西安710032 [7]湖南省肿瘤医院,湖南长沙410006

出　　处：《癌症》2001年第4期419-422,共4页Chinese Journal of Cancer

摘　　要：目的：观察国产拓扑替康单药二线治疗复发性小细胞肺癌（ small cell lung cancer, SCLC）和与顺铂联合方案治疗初治 SCLC的疗效及毒性。方法：采用多中心开放式研究方法，在 100例病例中有 97例符合入组条件，其中采用拓扑替康单药治疗的复发 SCLC 38例，用药方法为拓扑替康 1.25 mg/（ m2· d），连用 5天，每 3周一疗程；拓扑替康与顺铂联合用于初治 SCLC病例 59例，顺铂 80 mg/（ m2· d） d1，拓扑替康 1 mg/(m2· d)，连用 5天，每 3周一疗程。结果：拓扑替康单药用于复发 SCLC有效率为 37.5％，其中 CR 3.1％， PR 34.4％；与顺铂联合用于初治 SCLC有效率为 79.6％，其中 CR 22.4％， PR达 57.1％。主要的毒副作用为骨髓抑制，单药组 39 9％出现Ⅲ～Ⅳ度中性粒细胞缺乏，Ⅲ～Ⅳ度血小板下降 31.6％；而联合用药组Ⅲ～Ⅳ度中性粒细胞缺乏 61.0％，Ⅲ～Ⅳ度血小板下降 39.0％。非血液学毒性较轻。结论：拓扑替康是治疗 SCLC的有效药物之一，联合顺铂后可提高疗效。拓扑替康的主要毒副反应为血液学毒性。Objective： The aim of this study was to investigate the efficacy and toxicity of single agent topotecan(second line) or topotecan＋ cisplatin (first line) in the treatment of the patients with small cell lung cancer (SCLC). Methods： Ninety- seven patients were evaluated efficacy and toxicity in 100 eligible patients in a multiple center clinical trail. Topotecan was administrated as a second line single agent in 38 relapse SCLC patients and the dose of topotecan was 1.25 mg·（ m2· d）－ 1 for 5 days and repeat every 3 weeks. Topotecan＋ cisplatin regimen was used in the chemonaive SCLC patients and the dose of topotecan was reduced to 1 mg·（ m2· d）－ 1 for 5 days and the cisplatin was 80 mg·（ m2· d）－ 1 for one dose. Results： The response rate was 37.5％ as second line chemotherapy in relapse SCLC, including complete response of 3.1％ and the partial response 34.4. The response rate was 79.6％ (complete response,22.4％ and partial response,57.1％ ) when cisplatin was combined with topotecan in the chemonaive SCLC patients. Bone marrow suppression was the main toxicity of topotecan and GradeⅢ－Ⅳ neutropenia and thrombopenia was observed in 39.9％ and 31.6％ respectively in single agent regimen and 61.0％ and 39.9％ in combined regimen respectively. The non- hemotological toxicity was mineral. Conclusion： Topotecan may be an effective drugs for the patients with SCLC when used as the first or the second line regimen, and more efficacy when combine with cisplatin. The main toxicity of topotecan is hemotological toxicity.

关 键 词：拓扑替康 小细胞性肺癌 疗效 毒性 药物治疗 

分 类 号：R734.2[医药卫生—肿瘤] R730.53[医药卫生—临床医学]