作为晚期NKTCL的诱导疗法,sintilimab,pegaspargase和anlotinib:一个多中心II期研究
Dahui Li1, Chuanxu Liu2, Jiangbo Wan3
1Department of Lymphoma, Fudan University Shanghai Cancer Center, Shanghai, 200032, China, Shanghai, China.
Blood advances
|March 3, 2026
概括
在LEAP疗法对先进的额外节自然杀手/T细胞淋巴瘤有前途,在不适合高剂量甲状腺激素治疗的患者中实现高缓解率和持久生存,可控毒性.
科学领域:
- 在瘤学瘤学.
- 血液学 血液学 血液学
- 免疫学 免疫学 免疫学
背景情况:
- 外节自然杀手/T细胞淋巴瘤 (ENKTL) 是一种具有攻击性的爱斯坦-巴尔病毒相关的淋巴瘤.
- 晚期ENKTL在目前的治疗方法下表现不佳.
- 高剂量甲基酸盐 (HD-MTX) 疗法是有效的,但有毒的;低强度的选择缺乏耐用性.
研究的目的:
- 评估LEAP疗法的有效性和安全性,用于新诊断的IV期ENKTL.
- 评估完全缓解率 (CR) 和长期生存结果.
- 确定自身造血干细胞移植 (auto-HSCT) 在响应者中的作用.
主要方法:
- 未来的,多中心的,单臂的第二阶段试验.
- 治疗方法:辛提利马布,佩加斯帕加斯和安洛提尼布 (LEAP疗法) 最多8个21天周期.
- 资格: ECOG 0-3,年龄>65或≤65与HD-MTX的禁忌.
- 允许对完全响应者进行自动HSCT.
主要成果:
- 24周完整缓解率为72.9% (27/37),超过了55%的门.
- 估计的四年无进展生存率 (PFS) 和整体生存率 (OS) 分别为56.6%和75.2%.
- 接受自动HSCT的患者的复发率显著降低 (17.6%vs 60.0%),PFS改善 (HR=0.23).
- 3级以上的不良事件是有限的 (中性质减退,高白血症);没有因毒性而中止治疗或死亡.
结论:
- 在不适合HD-MTX的高级ENKTL患者中,LEAP疗法实现了高CR率和持久的存活率.
- 该疗法表现出可控的毒性,可能使治疗意图治疗成为可能.
- 随机验证是有必要的,以证实这些发现.
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