晚期胆道癌的二线胺基化疗:基于随机试验的个体患者级数据的元分析
Jaewon Hyung1, Minsu Kang2, Ilhwan Kim3
1Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Cancer research and treatment
|October 22, 2024
概括
与修改后的FOLFOX或修改后的FOLFIRI相比,在晚期的胆道癌症中,脂质组的义诺他干加上甲酸/莱科沃林显示出更高的整体存活率. 在选择治疗方案时,安全概况也需要考虑.
科学领域:
- 在瘤学瘤学.
- 胃肠病学 胃肠病学
- 临床试验 临床试验
背景情况:
- 晚期胆道癌 (BTC) 缺乏对推的二线胺基化学疗法的对比.
- 确定最佳的二线治疗对于改善BTC患者的治疗结果至关重要.
研究的目的:
- 为了比较脂质体里诺特干 (nal-IRI) 加上5-FU/LV对抗mFOLFOX,mFOLFIRI和5-FU/LV在高级BTC中的疗效.
- 评估BTC的不同二线化疗方案的整体存活率 (OS) 和安全概况.
主要方法:
- 两个第二阶段试验 (NIFTY和FIReFOX) 的个体患者水平元分析.
- 纳尔-IRI + 5-FU/LV,5-FU/LV,mFOLFOX和mFOLFIRI的比较使用日志等级测试和Cox比例危险建模.
- 分析包括277名来自治疗意向人群的患者.
主要成果:
- 与mFOLFOX (p=0.02) 和mFOLFIRI (p=0.03) 相比,Nal-IRI + 5-FU/LV显示出明显更好的生存状况.
- 多变量分析表明一致的趋势有利于nal-IRI + 5-FU/LV,尽管在统计学上并不显著 (HRs 1.39和1.36).
- 在mFOLFOX,mFOLFIRI和5-FU/LV之间没有观察到显著的OS差异. 腹在纳尔-IRI + 5-FU/LV时更频繁;外围神经病变在mFOLFOX时更频繁.
结论:
- 与mFOLFOX和mFOLFIRI相比,在晚期BTC中,脂质体里诺特干加上5-FU/LV显示出更高的生存结果.
- 选择二线治疗方案应平衡有效性与不同的安全性,包括腹和神经病变.
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