在上皮卵巢癌中随机研究两剂西斯丁与环胺
1Western Infirmary, Royal Infirmary, Stobhill General Hospital, Glasgow, UK.
Lancet (London, England)
|August 8, 1992
概括
更高剂量的西斯丁显著改善了晚期卵巢癌患者的生存率. 虽然毒性作用增加,但增强的生存率表明临床益处,等待更好的副作用管理.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 药理学 药理学 是一个学科.
背景情况:
- 西斯是卵巢癌的关键细胞毒剂.
- 对于治疗卵巢癌的最佳西斯丁剂量仍未确定.
- 先进的上皮卵巢癌需要有效的治疗策略.
研究的目的:
- 评估西斯普拉丁剂量升级对晚期上皮卵巢卵巢癌治疗结果的影响.
- 为了比较低剂量与高剂量西斯普拉丁疗法的疗效和毒性.
主要方法:
- 一个随机试验比较西斯普拉丁50 mg/m2 (低剂量) 与100 mg/m2 (高剂量) 加上环胺.
- 由于在临时分析中观察到显著的生存差异,招募工作被提前停止.
- 对患者进行了12个月的附加随访.
主要成果:
- 与低剂量相比,高剂量西斯丁显著降低了进展率 (0.55) 和死亡率 (0.53).
- 平均存活时间从69周 (低剂量) 增加到114周 (高剂量).
- 剩余疾病小于2厘米的患者接受高剂量西斯丁的治疗,平均存活时间为3年.
结论:
- 较高的西斯丁剂量在晚期卵巢癌中显示出更高的生存益处.
- 观察到高剂量西斯的毒性增加,特别是神经和听觉毒性.
- 高剂量西斯的临床效用取决于减轻其不良影响.
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