一项针对小细胞肺癌经大量预处理患者的紫杉醇II期研究。
A phase II study of paclitaxel in heavily pretreated patients with small-cell lung cancer.
作者信息
Smit E F, Fokkema E, Biesma B, Groen H J, Snoek W, Postmus P E
机构信息
Department of Pulmonary Diseases, University Hospital Groningen, The Netherlands.
出版信息
Br J Cancer. 1998;77(2):347-51. doi: 10.1038/bjc.1998.54.
The purpose of the study was to delineate the efficacy and toxicity of paclitaxel (Taxol, Bristol Myers Squibb) in the treatment of drug resistant small-cell lung cancer (SCLC). Patients with SCLC relapsing within 3 months of cytotoxic therapy received paclitaxel 175 mg m(-2) intravenously over 3 h every 3 weeks. The dose of paclitaxel was adjusted to the toxicity encountered in the previous cycle. Of 24 patients entered into the study, 24 and 21 were assessable for response and toxicity respectively. There were two early deaths and two toxic deaths. No complete and seven partial responses (29%) (95%CI 12-51%) were observed and five patients had disease stabilization. The median survival (n = 21) was 100 days. Life-threatening toxicity occurred in four patients; in others (non)-haematological toxicity was manageable. Paclitaxel is active in drug-resistant SCLC. Further investigation in combination with other active agents in this poor prognosis group is appropriate.
本研究的目的是明确紫杉醇（泰素，百时美施贵宝公司生产）治疗耐药性小细胞肺癌（SCLC）的疗效和毒性。细胞毒性治疗后3个月内复发的SCLC患者，每3周静脉输注紫杉醇175 mg/m²，持续3小时。根据前一周期出现的毒性反应调整紫杉醇剂量。进入本研究的24例患者中，分别有24例和21例可评估疗效和毒性。有2例早期死亡和2例毒性死亡。未观察到完全缓解，7例部分缓解（29%）（95%可信区间12 - 51%），5例病情稳定。中位生存期（n = 21）为100天。4例患者出现危及生命的毒性反应；其他患者的（非）血液学毒性反应可控制。紫杉醇对耐药性SCLC有活性。在这个预后较差的群体中，联合其他活性药物进行进一步研究是合适的。
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