杜尔瓦卢马布在晚期胆道癌症中:来自多个国际中心的大量患者队列的现实世界数据
Margherita Rimini1,2, Lorenzo Fornaro3, Masafumi Ikeda4
1Vita-Salute San Raffaele University, Milan, Italy.
概括
这项关于晚期胆道癌 (BTC) 的研究发现,西斯普拉丁,格姆西塔和杜尔瓦卢马布联合治疗的平均整体存活时间为15.6个月. 这些结果支持durvalumab.
科学领域:
- 在瘤学瘤学.
- 胃肠病学 胃肠病学
- 临床试验 临床试验
背景情况:
- 第一个真实世界的多中心研究,在晚期胆道癌症 (BTC) 中对西斯丁,格姆西塔宾和杜尔瓦卢马布进行研究.
- 扩大了患者队列,增加了样本大小和更长的随访时间.
- 专注于组合治疗在多样化的国际患者群体中的有效性和安全性.
研究的目的:
- 评估西斯普拉丁,格姆西塔宾和杜尔瓦卢马布在一个扩大队列的高级BTC患者的疗效和安全.
- 提供最新的现实数据,支持在临床实践中使用这种组合疗法.
主要方法:
- 多中心,多机构研究包括1358名在12个国家的55个中心的高级BTC患者.
- 患者接受了西斯普拉丁/格米西塔加杜尔瓦卢马布.
- 主要终点:无进展生存率 (PFS) 和总生存率 (OS). 二级终点:整体反应率 (ORR) 和安全性.
主要成果:
- 中位数PFS:7.6个月;中位数OS:15.6个月.
- ORR:35.6%;疾病控制率 (DCR):82.7%;疾病控制率 (DCR):82.7%.
- 任何级别的不良事件 (AE) 在89.3%; 3-4级AE在43.2%. 免疫相关的副作用 (irAEs) 发生在20.3%的患者中 (3-4级:3.0%).
- 对于OS的积极预后因素包括正常的白蛋白,正常的CEA,低的NLR,ECOGPS0和手术前.
结论:
- 来自扩大队列的最新发现加强了杜尔瓦卢马布在高级BTC治疗中与凝胺和柏结合使用的疗效和安全性.
- 这些结果支持在常规临床实践中采用这种组合疗法.
- 这些发现与III期TOPAZ-1试验的证据一致,并加强了这些证据.
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