用FOLFOXIRI治疗高风险复发局部晚期结肠癌的新辅助化疗:单臂II期试验
Y-W Zhou1, G-X Wei1, X-R Chen1
1Colorectal Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
ESMO open
|August 21, 2025
概括
在高风险局部晚期结肠癌 (hr- LACC) 患者中,使用FOLFOXIRI的新辅助化疗 (NAC) 显示出有前途的安全性和耐受性. 这种疗法有助于瘤降级和R0切除,这表明结果可能会得到改善.
科学领域:
- 癌症学
- 胃肠病学
- 临床试验
背景情况:
- 局部晚期结肠癌 (LACC) 具有复发和转移的高风险因素,需要有效的新辅助治疗.
- 评估新辅助化疗 (NAC) 与三种药物 (oxaliplatin,伊利诺特干和甲酸 - FOLFOXIRI) 的治疗方案对于HR-LACC的治疗至关重要.
研究的目的:
- 评估FOLFOXIRI作为NAC在HR-LACC患者中的安全性和可达性.
- 评估瘤反应,包括瘤回归度 (TRG) 和手术结果.
主要方法:
- 从2020年7月到2023年10月进行的单臂,开放式II期临床试验.
- 72 位患有 hr- LACC 的患者接受了四个周期的 NAC 与 FOLFOXIRI 治疗,随后进行手术和辅助治疗.
- 主要终点包括安全性,可交付性和TRG 0- 2率 (NCCN标准).
主要成果:
- 80. 6% 的患者完成了四个FOLFOXIRI疗程,51. 4% 患者出现了3-4级不良反应.
- 在所有切除患者 (61/ 61) 中实现了R0切除,TRG 0- 2率为86. 9%.
- 两年内瘤复发率为17. 2%.
结论:
- 用FOLFOXIRI进行的新辅助化疗在HR-LACC患者中显示出可接受的安全性和可发症性.
- 这种疗法显示出瘤降级和促进R0切除的潜力,因此需要在更大规模的研究中进行进一步的研究.
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