短程辐射之后的mFOLFOX-6加上avelumab用于局部发达的微卫星稳定的直肠腺癌:Averectal研究
Ali Shamseddine1, Rim Turfa2, Laudy Chehade1
1Department of Internal Medicine, Division of Hematology/Oncology, Naef K. Basile Cancer Institute - NKBCI, American University of Beirut Medical Center, Beirut, Lebanon.
European journal of cancer (Oxford, England : 1990)
|April 26, 2025
概括
在局部晚期直肠癌 (LARC) 中,在新辅助化疗和短期放射疗法 (SCRT) 中添加avelumab免疫疗法,改善了完全病理反应 (pCR) 率,而没有增加局部复发率 (LRR). 这种方法表明可接受的毒性和生活质量 (QoL).
科学领域:
- 在瘤学瘤学.
- 胃肠病学 胃肠病学
- 免疫治疗是一种免疫疗法.
背景情况:
- 总的新辅助疗法 (TNT) 提高了局部晚期直肠癌 (LARC) 的结果,但人们对短期放射治疗 (SCRT) 的局部复发率 (LRR) 增加存在担忧.
- 免疫治疗和放射治疗之间的潜在协同作用为改善LARC治疗效率提供了一个有希望的途径,包括微卫星稳定 (MSS) 瘤.
研究的目的:
- 评估LARC患者在SCRT后新辅助化疗 (mFOLFOX-6) 添加avelumab免疫疗法的疗效和安全性.
- 评估这种综合治疗方法对完整的病理反应 (pCR),无病生存期 (DFS),局部复发率 (LRR) 和生活质量 (QoL) 的影响.
主要方法:
- 一项II期,开放式,单臂,多中心研究招募了接受SCRT (5 Gy x 5 分数) 的LARC患者.
- 然后,患者接受了6个周期的mFOLFOX-6化疗,每隔2周与avelumab相结合,然后进行全腹腔切除 (TME).
- 主要结局是与历史对照相比的pCR;次要结局包括3年DFS,LRR,ImmunoScore (IS) 与结局,安全性和QoL的关联.
主要成果:
- 在44名注册的MSS患者中,有40人完成了治疗. 15名患者 (37.5%) 实现了pCR,67.5% 具有重大病理反应.
- 三年的DFS为85%,低LRR为2.5%. 平均DFS为42个月,平均OS为46.3个月.
- 在pCR患者中观察到更高的平均IS. 毒性是可以接受的,严重的不良事件发生在23.5%的患者中. 产品质量保持稳定.
结论:
- 在SCRT和TME后,在新辅助化疗 (mFOLFOX6) 添加avelumab后,在LARC患者的pCR显著改善,而不会增加LRR.
- 治疗方案显示可接受的毒性和维持生活质量,这表明免疫疗法在这种情况下具有有益的作用.
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