在高剂量伊马替尼的胃肠道 stromal 瘤中无进展的生存率:随机试验
Jaap Verweij1, Paolo G Casali, John Zalcberg
1Department of Medical Oncology, Erasmus University Medical Centre, Groene Hilledijk 301, 3075 EA Rotterdam, Netherlands. j.verweij@erasmusmc.nl
Lancet (London, England)
|September 29, 2004
概括
每日400毫克的伊马蒂尼布剂量足以在胃肠道 stromal 瘤 (GIST) 的初始反应. 然而,每天服用两次剂量显著改善了转移性GIST患者的无进展生存率.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 伊马替尼布是全球批准的胃肠道 stromal 瘤 (GIST) 的治疗方法.
- 这项研究研究了依赖于剂量的伊马替尼对转移性GIST患者治疗反应和无进展生存的剂量影响.
研究的目的:
- 为了评估伊马蒂尼布剂量与转移性GIST患者的患者结果之间的关系.
- 为了确定较高的伊马替尼布剂量是否可以改善无进展生存率和应答率.
主要方法:
- 一项随机试验涉及946名转移性GIST的患者.
- 患者每天接受一次或每天两次400毫克伊马蒂尼布.
- 无进展生存率是主要终点,并进行治疗意向分析.
主要成果:
- 每天两次接受伊马替尼布的患者的无进展生存时间明显长 (HR 0.82; p=0.026).
- 两组之间没有观察到响应率 (完全,部分,稳定疾病) 的显著差异.
- 治疗一般耐受良好,每天两次服用组的剂量减少和中断更多.
结论:
- 为了在GIST中获得初始反应,每天400毫克伊马替尼足够.
- 每天两次服用400毫克伊马替尼布,在延长转移性GIST的无进展生存期方面具有显著的益处.
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