...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Lung cancer: Journal of the International Association for the Study of Lung Cancer >Phase I trial of gemcitabine and carboplatin in metastatic non-small-cell lung cancer: a Groupe Francais de Pneumo-Cancerologie Study.
【24h】

Phase I trial of gemcitabine and carboplatin in metastatic non-small-cell lung cancer: a Groupe Francais de Pneumo-Cancerologie Study.

机译：第一阶段试验的吉西他滨和卡铂转移性非小细胞肺癌:GroupeFrancais Pneumo-Cancerologie Study。

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Background: The purpose of this study was to determine the maximum-tolerated dose (MTD) and the dose-limiting toxicity (DLT) of the 21 days carboplatin plus gemcitabine regimen in previously untreated patients with stage IV non small-cell lung cancer (NSCLC). Methods: At least three patients were entered at each dose level. The starting dose was carboplatin AUC 4 mg/ml per min (Area Under the Curve; Calvert formula) on day 1 and gemcitabine 750 mg/m(2) on days 1 and 8. Carboplatin was increased to AUC 5 (level 3, 4) then to AUC 6 (level 5-7). Gemcitabine was increased to 875 (level 2, 3), 1000 (level 4, 5), 1250 (level 6) and finally 1500 mg/m(2) (level 7). Twenty-nine patients were entered into this phase I study. Results: At dose level 6, a DLT (grade 4 thrombocytopenia) was observed in one out of six patients. At dose level 7, no DLT was observed during the first course, so the MTD was not reached. During the second course, two out of four patients presented grade 4 thrombocytopenia. None of the five patients receiving two courses at level 6 presented a DLT, so this level was retained for further phase II studies. Of the 25 patients assessable for response, five achieved partial responses with a response rate of 20% (95% CI, 7 to 41%). The median survival time was 7 months and the 1-year survival rate was 24% (95% CI, 9 to 45%). Conclusion: The combination of carboplatin given on day 1 and gemcitabine given on days 1 and 8 every 3 weeks seems to be an acceptable regimen. The DLT consists exclusively of severe thrombocytopenia. Despite the MTD was not reached with carboplatin AUC 6 mg/ml per min and gemcitabine 1500 mg/m(2), the recommended dose for further phase II studies is carboplatin AUC 6 mg/ml per min and gemcitabine 1250 mg/m(2).
机译：背景:本研究的目的确定最大耐受剂量(MTD)和21天的dose-limiting毒性(DLT)卡铂+吉西他滨方案以前未经治疗的四期非患者小细胞肺癌(NSCLC)。三个病人进入每一个剂量水平。起始剂量卡铂AUC 4毫克/毫升/分钟(曲线下的面积;第一天和吉西他滨750毫克/ m 1和(2)天8. 4)然后AUC 6(要求等级5 - 7)。增加到875(水平2、3),1000(4级,5),1250(6级),最后1500毫克/米(2)水平7)。29例患者进入第一阶段研究。观察(4级血小板减少症)6个病人。观察到在第一次课程,所以MTD没有达到。4名患者4级血小板减少症。没有五个病人接受两个课程在6级了DLT,所以这个级别保留进一步二期研究。病人应评税反应,五部分反应的反应率为20%(95% CI, 7 - 41%)。7个月及1年生存率为24%(95%可信区间,9 45%)。卡铂在第一天和吉西他滨天给1和8似乎每3周一个可接受的方案。专门的严重的血小板减少症。MTD不是与卡铂AUC 6毫克/毫升通过闵and gemcitabine 1500 mg / m (2), the推荐剂量为进一步二期研究卡铂AUC 6毫克/毫升/分钟和吉西他滨1250 mg / m(2)。

著录项

相似文献

  • 外文文献
  • 中文文献
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号