对辅助剂FOLFIRI,FOLFOX或5-FU/Leucovorin进行II/III期直肠癌的跨组随机化III期研究:ECOG-ACRIN E3201
Audrey E Kam1, Fengmin Zhao2, Neal J Meropol3,4
1Rush University Medical Center, Chicago, IL, USA.
The oncologist
|December 15, 2025
概括
这项研究比较了辅助剂FOLFIRI,FOLFOX和5-FU/LV用于直肠癌. 两种疗法之间没有发现总体存活率或无病存活率的显著差异.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 胃肠道癌症 胃肠道癌症是什么?
背景情况:
- 辅助性5-FU单疗法是II/III期直肠癌的标准.
- 这项试验比较了FOLFIRI,FOLFOX和5-FU/LV作为辅助治疗.
- 这项研究被注册为NCT00068692.2.
研究的目的:
- 在直肠癌患者中比较辅助剂FOLFIRI,FOLFOX和5-FU/LV的疗效和安全性.
- 评估整体存活率 (OS),无病存活率 (DFS),关节的保存,耐受性和生活质量 (QOL).
主要方法:
- 患有直肠腺癌的患者接受了手术前或手术后的5-FU化疗放射治疗 (CRT).
- 随机选择的患者接受了FOLFIRI的8个周期,FOLFOX的8个周期,或5-FU/LV的3个周期.
- 该试验旨在招募3,150名患者,但提前结束.
主要成果:
- 在早期关闭之前,注册了225名患者 (179人随机分类).
- 在59%的患者中发生了3/4级毒性,主要是中性质减退,白血减退和腹.
- 经过9.7年的中位数随访后,治疗组之间没有观察到OS或DFS的显著差异.
结论:
- 在直肠癌患者中,FOLFIRI和FOLFOX可以安全地在CRT后给药,预计有毒性.
- 早期试验结束和小样本大小限制了检测显著生存差异的统计能力.
- 可能需要进一步的研究来确认FOLFIRI和FOLFOX在关节保护方面的潜在数值优势.
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