新辅助药FOLFIRINOX与可切除胰腺头癌的前期手术 (NORPACT-1):一个多中心,随机的第二阶段试验
Knut Jørgen Labori1, Svein Olav Bratlie2, Bodil Andersson3
1Department of Hepato Pancreato Biliary Surgery, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
The lancet. Gastroenterology & hepatology
|January 18, 2024
概括
在2期试验中,新辅助药FOLFIRINOX与前期手术相比,没有改善可切除胰腺癌的存活率. 报告指出了实施方面的挑战,建议未来的试验应以生物标志物为导向.
科学领域:
- 在瘤学瘤学.
- 手术瘤学手术瘤学
- 胃肠病学 胃肠病学
背景情况:
- 辅助剂修饰的甲,莱可沃林,伊利诺特干和氧化 (FOLFIRINOX) 改善了切除胰腺癌的存活率.
- 新辅助剂FOLFIRINOX与胰腺管道腺癌的前期手术的疗效仍在调查中.
研究的目的:
- 为了比较新辅助药FOLFIRINOX在切除胰腺管腺癌患者的前置手术中的疗效和安全性.
- 作为主要终点,评估18个月的整体存活率.
主要方法:
- 一个多中心,随机的第二阶段试验 (NORPACT-1),涉及140名胰腺腺癌切除患者.
- 患者被分配给新辅助的FOLFIRINOX,然后进行手术和辅助化疗,或者进行前期手术,然后进行辅助化疗.
- 主要终点是18个月的整体存活率,分析了治疗意图和每项方案的人群.
主要成果:
- 根据治疗意图分析,18个月的整体存活率在新辅助性FOLFIRINOX组中为60%,而在前期手术组中为73% (p=0·032).
- 新辅助性FOLFIRINOX的平均整体存活时间为25.1个月,而前期手术的平均存活时间为38.5个月 (HR 1.52; p=0·050).
- 3级或更严重的不良事件发生在58%的新辅助性FOLFIRINOX组中,而前期手术组的不良事件为40%.
结论:
- 与可切除胰腺管腺癌的前期手术相比,新辅助药FOLFIRINOX没有显示出生存益处.
- 新辅助剂FOLFIRINOX的实施提出了挑战.
- 未来对可切除胰腺管腺癌的研究应该集中在生物标志物驱动的治疗顺序上.
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