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英国现实世界证据使用Durvalumab加Cisplatin和Gemcitabine在晚期胆道癌症中通过早期获取计划

Harry Daniels¹, Mona Hassan², Omer Babiker¹

¹Department of Oncology, Queen Elizabeth Hospital, Mindelsohn Way, Birmingham B15 2GW, UK.

|September 13, 2025

概括

现实世界的数据显示,杜尔瓦卢马布加化疗对晚期胆道癌症有效. 这种治疗在英国常规临床实践中表现出可比的疗效和有利的安全性.

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:

杜尔瓦卢马布 (抗PD-L1) 结合凝胺和西斯普拉丁是基于TOPAZ-1试验结果的先进胆道癌症 (BTC) 的标准一线治疗方法.
在常规临床实践中验证疗效和安全性时,现实数据至关重要.
这项研究评估了英国早期对BTC患者的杜尔瓦卢马布,格姆西塔宾和西斯普拉丁的获取数据.

研究的目的:

评估一线杜尔瓦卢马布加上吉姆西塔宾和西斯普拉丁在高级BTC的实际安全性和有效性.
将这些现实结果与在关键的TOPAZ-1III期试验中报告的结果进行比较.
为了评估英国患者队列的治疗结果,这些患者获得了早期的治疗方案.

主要方法:

在英国10个中心对134名晚期BTC患者进行了回顾性分析,这些患者接受了杜尔瓦卢马布,格姆西塔和西斯的治疗.
在2022年4月至2023年12月期间收集的数据.
主要终点:无进展生存期 (PFS). 二级终点:整体存活率 (OS),整体反应率 (ORR) 和安全性 (不良事件).

主要成果:

平均PFS为8.83个月,与TOPAZ-1的7.2个月相比.
平均生存期为12个月,略低于TOPAZ-1的12.8个月.
ORR为29.1% (托帕兹-1:26.7%),疾病控制率为61.2%. 总体AE在52.3%的患者中观察到,3-4级AE在6.8%中,这表明毒性概况可能低于TOPAZ-1中报告的毒性概况.

结论:

来自英国中心的现实数据支持durvalumab加上gemcitabine和cisplatin在高级BTC中的有效性.
该治疗方案的疗效与TOPAZ-1试验的结果相比较.
在这个现实世界队列中观察到有利的安全性,这表明在常规临床实践中耐受性良好.

关键词:

胆道癌症是胆道癌症.胆性癌 (Cholangiocarcinoma) 是一种癌症.达尔瓦卢马布 (Durvalumab) 是一种耐药的药物.免疫检查点抑制剂免疫检查点抑制剂免疫疗法免疫疗法现实世界的证据.

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