盐酸尼莫司汀（ACNU）联合紫杉醇治疗难治性小细胞肺癌的 II 期研究。

Phase II study of nimustine hydrochloride (ACNU) plus paclitaxel for refractory small cell lung cancer.

机构信息

Department of Respiratory Medicine, Toho University Omori Medical Center, Japan.

出版信息

Lung Cancer. 2009 Dec;66(3):350-4. doi: 10.1016/j.lungcan.2009.03.003. Epub 2009 Apr 1.

DOI:10.1016/j.lungcan.2009.03.003

PMID:19342118

Abstract

PURPOSE

Bi-weekly administrations of nimustine hydrochloride (ACNU) plus paclitaxel were evaluated in this phase II study in patients with refractory small cell lung cancer (SCLC).

METHODS

Patients who had disease progression within 3 months after treatment with irinotecan (CPT-11)-containing regimens were entered. They were treated with every other week administrations of ACNU 50 mg/m(2) plus paclitaxel 110 mg/m(2) on day 1 over 2 weeks.

RESULTS

Twenty-four patients (20 males and 4 females, median age of 64 years, 17 patients with Eastern Cooperative Oncology Group [ECOG] performance status [PS] 0-1 and 7 patients with PS 2) participated in the trial. Of the 24 refractory patients after CPT-11 containing regimens, 17 patients had been given etoposide plus platinum. There were six partial responses, and an overall response rate of 25% (95% confidence interval, 10-46%) was obtained. The median time to progression and the median survival time after enrollment into this study were 2.8 and 5.8 months, respectively. The median overall survival from the first-line treatment was 19.5 months. The major toxicity was myelosuppression. Grade 4 neutropenia occurred in 13% of patients, and Grade 4 thrombocytopenia was observed in 13% of patients. There was one treatment-related death, attributed to pneumonitis.

CONCLUSION

Bi-weekly administrations of ACNU plus paclitaxel provided a practical and well-tolerated regimen that was active for CPT-11-refractory SCLC.

摘要

目的

在这项 II 期研究中，评估了盐酸尼莫司汀（ACNU）联合紫杉醇每两周给药方案在复发性小细胞肺癌（SCLC）患者中的疗效。

方法

纳入在接受含伊立替康（CPT-11）方案治疗后 3 个月内疾病进展的患者。患者接受 ACNU 50mg/m²每两周一次联合紫杉醇 110mg/m²第 1 天给药，每 2 周为一个周期。

结果

24 例患者（20 例男性和 4 例女性，中位年龄 64 岁，17 例患者的东部肿瘤协作组（ECOG）体力状况[PS]为 0-1，7 例患者 PS 为 2）参与了该试验。在 24 例 CPT-11 方案治疗后复发的患者中，17 例患者接受了依托泊苷联合铂类药物治疗。6 例患者获得部分缓解，总缓解率为 25%（95%置信区间，10-46%）。入组后中位无进展生存期和中位总生存期分别为 2.8 个月和 5.8 个月。一线治疗的中位总生存期为 19.5 个月。主要毒性为骨髓抑制。13%的患者出现 4 级中性粒细胞减少，13%的患者出现 4 级血小板减少。有 1 例与治疗相关的死亡，归因于肺炎。