Phase Ⅱ Clinical Study of Topotecan in Treatment of Patients with Small Cell Lung Cancer： A Multiple Center Clinical Trail
10.3321/j.issn:1000-467X.2001.04.019
- VernacularTitle:拓扑替康治疗小细胞肺癌Ⅱ期临床研究
- Author:
Li ZHANG
1
;
Zhong-Jun XIA
;
Zhong-Zhen GUAN
;
Pei-Wen LI
;
You-Ning LIU
;
Xiao-Dian HU
;
Qing-Hua ZHOU
;
Dian-Tao NI
;
Xue-Lan WANG
Author Information
1. Sun Yat-sen University of Medical Sciences
- From:Chinese Journal of Cancer
2001;20(4):419-422
- CountryChina
- Language:Chinese
-
Abstract:
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 Grade Ⅲ -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.
