在先进的胃肠道胰腺神经内分泌瘤中,雷戈拉费尼布加上阿维卢马布:第二阶段试验和相关分析分析
Sophie Cousin1, Jean-Philippe Guégan2, Lola Jade Palmieri1,2
1Department of Medicine, Institut Bergonié, Bordeaux, France.
Nature cancer
|April 9, 2025
概括
这项研究表明,结合regorafenib和avelumab可为晚期胃肠道胰腺神经内分泌瘤 (GEP-NENs) 提供潜在的治疗方法. 虽然观察到反应,但需要进一步的研究来确定这种组合治疗的预测生物标志物.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 胃肠病学 胃肠病学
背景情况:
- 胃肠道胰腺神经内分泌瘤 (GEP-NENs) 代表了一组多样化的瘤,治疗策略有限.
- 先进的GEP-NEN往往对现有治疗具有抗性,需要新的治疗方法.
研究的目的:
- 为了评估结合regorafenib (一种多酶抑制剂) 与avelumab (一种PD1配体1抑制剂) 的疗效和安全性,在患有晚期GEP-NENs的患者中.
- 评估这个患者群体的客观应答率和无进展生存率.
主要方法:
- 一个贝叶斯研究的第二阶段,涉及47名患有高级,差异很好的GEP-NEN或GEP神经内分泌癌的参与者.
- 参与者在28天的周期中每天接受雷戈拉费尼布 (160毫克) 和两周一次的阿维卢马布 (10毫克/公斤).
- 根据客观应答率和无进展生存率来评估有效性,并通过与治疗相关的不良事件来评估安全性.
主要成果:
- 6个月的客观应答率为18% (95% CI: 8-31%),中位数无进展生存时间为5.5个月 (95% CI: 3.6-8).
- 观察到持续性反应,持续时间中位数为16.6个月.
- 常见的与治疗相关的不良事件包括疲劳,腹和手掌 - 脚掌红色素消化症,这些通常是可以管理的.
结论:
- 雷戈拉费尼布和阿维卢马布的组合表明,在治疗晚期GEP-NENs方面具有临床潜力.
- 探索性分析表明PD1和胺2,3-二氧化酶1的表达可能与治疗耐药性有关.
- 随机试验的进一步验证,以及预测生物标志物的识别,对于优化这种治疗策略至关重要.
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