拓扑替康联合顺铂治疗日本小细胞肺癌患者的 II 期研究。

Phase II study of topotecan with cisplatin in Japanese patients with small cell lung cancer.

机构信息

Division of Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.

出版信息

Anticancer Res. 2011 Oct;31(10):3449-56.

PMID:21965760

Abstract

BACKGROUND

We conducted a phase II study of topotecan (Tp) with cisplatin (CDDP) in previously untreated Japanese patients with extensive-disease small cell lung cancer (ED-SCLC).

PATIENTS AND METHODS

In stage 1, a total of 30 patients were allocated to Tp 0.65 mg/m(2) with CDDP 60 mg/m(2) day 1 or Tp 1.00 mg/m(2) with CDDP day 5 following prophylactic granulocyte colony stimulating factor (G-CSF) from day 6. In stage 2, the selective combination in 29 patients was evaluated for response rate, toxicity and overall survival.

RESULTS

In stage 1, Tp 1.00 mg/m(2) with CDDP day 5 was selected this schedule had a better hematological profile. In stage 2, the response rate was 83%, and grade 3/4 adverse events were hematological-toxicities. The median survival time was 17.5 months and the 1 year survival rate was 79%.

CONCLUSION

Combination of Tp and CDDP on day 5 with G-CSF support is safe and effective for previously untreated ED-SCLC Japanese patients.

摘要

背景

我们在未经治疗的广泛期小细胞肺癌（ED-SCLC）日本患者中进行了拓扑替康（Tp）联合顺铂（CDDP）的 II 期研究。

患者和方法

在第 1 阶段，共 30 名患者被分配到 Tp 0.65mg/m(2)联合 CDDP 60mg/m(2)第 1 天或 Tp 1.00mg/m(2)联合 CDDP 第 5 天，同时从第 6 天开始使用预防性粒细胞集落刺激因子（G-CSF）。在第 2 阶段，评估了 29 名患者的选择性联合治疗的反应率、毒性和总生存期。