ECOG 6293:在晚期结肠直肠癌中进行Raltitrexed的II期研究
Chengwei Peng1, Paul Catalano2, John Zalcberg3
1Northwestern University, Chicago, IL.
The oncologist
|February 20, 2026
概括
拉尔蒂特雷克塞德是一种直接的胺酸合成酶 (TS) 抑制剂,在晚期结肠直肠癌 (CRC) 患者中显示出有限的疗效. 这项II期试验没有发现显著的响应率,这表明拉尔特雷克塞德不是对CRC的可行的治疗选择.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 胺酸合成酶 (TS) 抑制是结直肠癌 (CRC) 治疗的关键策略.
- 5-Flurouracil (5-FU) 是一种间接的TS抑制剂,通常用于CRC疗法.
- 作为一种直接的TS抑制剂,拉尔提特雷克塞德 (Raltitrexed) 已被研究在CRC中潜在的提高疗效和毒性.
研究的目的:
- 评估拉利特雷克塞德在患有晚期结直肠癌 (CRC) 的患者的疗效和安全性.
- 根据先前的5-FU治疗,评估不同患者层面的拉尔特雷克塞德的有效性.
- 探索作为生物标志物的胺酸合成酶 (TS) 表达的预后价值.
主要方法:
- 一项二期ECOG-ACRIN试验从1995年12月到1998年12月,招募了101名晚期CRC患者.
- 患者根据先前的治疗进行了分层:以前没有服用5-FU,没有使用leucovorin的5-FU或使用leucovorin的5-FU.
- 拉利特雷克塞德3mg/m2每3周一次;主要终点包括目标反应率 (ORR) 和毒性.
主要成果:
- 对拉利特雷克塞德的整体目标响应率 (ORR) 在所有阶层都很低,没有发现显著差异.
- 中位数无进展生存期 (mPFS) 和中位数总生存期 (mOS) 是有限的,最高的mOS是在5FU先天组 (14.5个月) 中观察到的.
- 由于ORR低,试验没有进入第二阶段;作为生物标志物的TS表达产生了不确定的结果.
结论:
- 拉利特雷克塞德的疗效有限,并没有在晚期CRC患者中实现显著的应答率.
- 该研究得出结论,TS表达不是可靠的生物标志物,用于预测这个患者群体的拉尔特雷克塞德反应.
- 在这项II期试验中,没有发现与拉利特雷克塞德治疗相关的新安全问题.
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