在先前治疗的高级神经内分泌癌患者中的尼沃卢马布±伊皮利马布:GCO-001 NIPINEC随机II期试验
Thomas Pierre Walter1, Julien Mazieres2, Josiane Otto3
1Department of Medical Oncology, Hospices Civils de Lyon, Lyon, France; Gastroenterology and technologies for Health, Research Unit INSERM UMR 1052 CNRS UMR 5286, Cancer Research Center of Lyon, Lyon, France.
尼沃卢马布±伊皮利穆马布在化疗失败后,作为神经内分泌癌 (NECs) 的二线治疗,显示出适度的疗效. 需要进一步的研究来探索早期使用或与化疗结合,以改善先进NEC的结果.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 胃肠道胰腺癌和肺部神经内分泌癌
背景情况:
- 胃肠瘤 (GEP) 和肺大细胞神经内分泌癌 (NEC) 缺乏标准的二线疗法.
- 研究新的治疗策略对于改善先进NECs的结果至关重要.
研究的目的:
- 评估单独或与伊皮利穆马布结合的尼沃卢马布作为高级GEP和肺大细胞NEC的第二或第三线治疗的疗效.
- 评估第8周客观反应率 (ORR) 作为主要终点.
主要方法:
- 一个非比较的,开放的,第二阶段试验 (GCO-001-NIPINEC) 招募了NEC晚期耐化疗的患者.
- 随机分配患者接受尼沃卢马布或尼沃卢马布加上伊皮利穆马布,长达2年.
- 主要终点是研究人员在8周评估的ORR.
主要成果:
- 在8周后的ORR为nivolumab的7.2%,为nivolumab-ipilimumab的14.0%.
- 最好的ORR分别为9.6%和20.9%,两只手臂的中位数无进展,总生存时间约为2个月和6个月.
- 3-4级不良事件包括喘息,肝酶升高,呼吸不全和贫血,尼沃卢马布手臂有一例与治疗相关的死亡.
结论:
- 尼沃卢马布-伊皮利穆马布显示出作为NEC患者的第二或第三线治疗选择的潜力.
- 观察到的益处是有限的,这表明需要进行评估早期治疗开始或与化疗结合的研究.
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