在晚期非小细胞肺癌中使用白金基和非白金基化疗:一项随机多中心试验
V Georgoulias1, E Papadakis, A Alexopoulos
1Department of Medical Oncology, University General Hospital of Heraklion, POBox 1352, Heraklion 71110, Crete, Greece. georgsec@med.uch.gr
Lancet (London, England)
|May 30, 2001
概括
这项研究比较了多塞塔塞尔与西斯普拉丁与吉姆西塔宾,用于高级非小细胞肺癌. 吉米西塔和多塞在未经化疗治疗的患者中显示出类似的疗效,但更好的安全性.
科学领域:
- 医学瘤学 医学瘤学
- 临床试验 临床试验
- 肺癌研究研究 肺癌研究
背景情况:
- 多塞塔塞尔与西斯普拉丁或吉姆奇塔宾结合使用,已成为非小细胞肺癌 (NSCLC) 的治疗方法.
- 这项研究旨在比较两种活性化疗方案在晚期NSCLC中的疗效和安全性.
研究的目的:
- 为了比较dcetaxel/cisplatin与gemcitabine/docetaxel在晚期NSCLC患者中的疗效和安全性.
- 为了评估客观的反应率,反应的持续时间,瘤进展的时间,以及以前未经治疗的患者的存活率.
主要方法:
- 一项前性,随机化,多中心试验,涉及441名没有先前化疗的IIIB或IV期NSCLC患者.
- 患者被分配给多塞塔克塞尔/西斯普拉丁或格姆西塔宾/多塞塔克塞尔,两者都配有复合的人类颗粒细胞殖民地刺激因子.
- 使用世界卫生组织 (WHO) 标准评估反应和毒性,并进行治疗意图分析.
主要成果:
- 在多塞塔塞尔/西斯普拉丁组 (32.4%) 和格姆西塔宾/多塞塔塞尔组 (30.2%) 之间,客观反应率相似.
- 没有观察到响应的中位持续时间,瘤进展的时间或整体生存率 (1年和2年) 的显著差异.
结论:
- 杜塞塔克塞尔/西斯普拉丁和吉姆奇塔宾/杜塞塔克塞尔在晚期非小细胞癌患者中表现出类似的抗癌活性.
- 与多塞塔克塞尔和西斯普拉丁相比,吉姆西塔宾和多塞塔克塞尔的组合呈现出更有利的毒性概况.
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