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对于高风险的非肌肉侵入性膀癌的Durvalumab的静脉内注射:希腊GU癌症组的第二阶段研究

Charalampos Fragkoulis¹, Aristotelis Bamias², Nikos Gavalas²

¹Urology Department, Georgios Gennimatas Hospital, Athens, Greece.

European urology

|January 18, 2025

概括

静脉注射杜瓦卢马布为高风险的非肌肉侵入性膀癌 (NMIBC) 患者提供了一个有希望的低毒性选择,这些患者先前的菌卡尔梅特-盖林 (BCG) 治疗失败了,显示出令人鼓舞的膀保存率.

科学领域:

泌尿器科泌尿器科泌尿器科泌尿器科
在瘤学瘤学.
免疫治疗是一种免疫疗法.

背景情况:

高风险的非肌肉侵入性膀癌 (NMIBC) 在菌卡尔梅特-盖林 (BCG) 失败后需要膀节省的选择.
系统性免疫检查点抑制剂 (ICI) 显示有效性,但具有显著的毒性.
开发针对NMIBC的局部治疗方法对于改善患者治疗结果至关重要.

研究的目的:

评估BCG失败后高风险NMIBC患者的静脉注射杜尔瓦卢马布的安全性和疗效.
评估高度复发率 (HGR) 和膀完整生存率.
确定这种新型体内免疫疗法的可行性和毒性概况.

主要方法:

一个单臂的2期研究,涉及30名BCG失败后NMIBC患者.
患者每6周接受静脉注射杜尔瓦卢马布1000毫克.
关键的终点包括无HGR率,膀完整存活率和与治疗相关的不良事件.

主要成果:

一年无HGR的比率为39% (95% CI 18-59%).
一年膀完整存活率为78% (95%CI为57-89%).
治疗表明毒性微不足道,只有17%的患者报告了1级出血症.

结论:

静脉注射杜尔瓦卢马布是高风险的NMIBC后BCG衰竭的可行和耐受性良好的治疗方法.
观察到的疗效表明,与系统性ICI管理相比,它具有潜在的优势.
需要对NMIBC的静脉注射杜尔瓦卢马布进行进一步调查.

关键词:

巴西勒斯卡尔梅特-盖林菌在 Durvalumab 中使用.内性内性膀癌是非肌肉侵入性的膀癌.经常性的反复性.

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