新辅助剂FOLFOXIRI加贝瓦齐祖马布,不需要放射治疗高风险直肠癌:多中心II期试验
Takeru Matsuda1, Yoshiaki Nagatani2, Yohei Funakoshi2
1Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.
BJS open
|February 9, 2026
概括
新辅助剂FOLFOXIRI加贝瓦齐祖马布化疗,没有放射治疗,对高风险的局部晚期直肠癌 (LARC) 进行了良好的局部控制. 这种方法为那些不适合盆腔放射治疗的患者提供了潜在的选择,尽管病理完整反应率适度不高.
科学领域:
- 在瘤学瘤学.
- 胃肠道癌症研究研究
- 临床试验分析
背景情况:
- 对高风险局部晚期直肠癌 (LARC) 的最佳新辅助治疗进行了辩论.
- 放射治疗是一种常见的新辅助策略,但具有潜在的毒性.
- 目前正在探索用于LARC管理的仅替代化疗方案.
研究的目的:
- 为了评估新辅助剂FOLFOXIRI (甲,乐可沃林,氧沙,伊利诺特干) 加贝瓦西祖马布在没有放射治疗的情况下在高风险LARC患者的疗效和安全性.
- 评估病理完整反应 (pCR),R0切除,局部复发 (LR),无复发生存 (RFS) 和整体生存 (OS).
主要方法:
- 这是一项前性,单臂的第二阶段试验,涉及四个日本机构的31名高风险LARC患者.
- 患者接受了FOLFOXIRI加贝瓦齐祖马布的四个周期,随后是单独的FOLFOXIRI的两个周期.
- 在neoadjuvant治疗后进行了全腹膜切除;终点包括pCR,R0切除,LR,RFS,OS和安全性.
主要成果:
- 病理完整响应 (pCR) 率为10% (3/31),并且在97% (30/31) 的患者中实现了R0切除.
- 三年累计局部复发 (LR) 率为3%,三年无复发生存率 (RFS) 为73%,整体生存率 (OS) 为81%.
- 在29%的患者中发生了≥3级的中性质减退;术后并发症包括7%的静脉漏.
结论:
- 在高风险的LARC中,新辅助剂FOLFOXIRI加贝瓦齐祖马布在没有放射治疗的情况下实现了有利的局部控制.
- 虽然与基于放射治疗的疗法相比,pCR率是适度的,但这种仅化学疗法的方法对于某些患者来说是一个可行的选择.
- 这种策略可能有利于不适合盆腔放射治疗的患者,提供良好的局部控制和可接受的毒性.
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