在患有肌肉侵入性膀癌 (AURA Oncodistinct-004) 的患者中使用avelumab的新辅助疗法:一项2期多中心临床试验
Jérémy Blanc1, Aurélien Carnot2, Philippe Barthélémy3
1Medical Oncology Department, Institut Jules Bordet, Hôpital Universitaire de Bruxelles, Brussels, Belgium.
Journal for immunotherapy of cancer
|May 24, 2025
概括
新辅助药阿维卢马布与剂量密集的MVAC化疗相结合,在肌肉侵入性膀癌 (MIBC) 中表现出有希望的疗效和安全性. 这种组合为能够接受西斯普拉丁治疗的患者提供了对gemcitabine-cisplatin的潜在选择.
科学领域:
- 在瘤学瘤学.
- 泌尿器细胞癌的癌症.
- 膀癌治疗方法 膀癌治疗方法
背景情况:
- 免疫疗法是非转移性肌肉侵入性膀癌 (MIBC) 的标准治疗方法.
- 在MIBC中,化学免疫治疗的最佳化疗伙伴尚未确定.
- 在AURA试验中,研究了针对MIBC的基于新辅助剂avelumab的治疗方案.
研究的目的:
- 评估新辅助药阿维卢马布与MIBC患者的不同化疗方案的疗效和安全性.
- 为了比较剂量密度高的甲状腺素-维恩布拉斯-多克索鲁比辛-西斯普拉丁 (ddMVAC) 加上阿维卢马布 (ddMVAC-A) 与吉西塔宾-西斯普拉丁加上阿维卢马布 (GC-A) 在接受西斯普拉丁治疗的患者中.
- 评估在非合适接受西斯的患者中,阿维卢马布单一治疗 (A) 与阿维卢马布与帕克利塔克塞尔 - 杰米丁 (PG-A) 的对比.
主要方法:
- 一个多中心的2期临床试验 (AURA,NCT03674424) 招募了137名非转移性MIBC患者.
- 接受西斯普拉丁治疗的患者随机分为ddMVAC-A或GC-A.
- 不能接受西斯普拉丁的患者接受了A或PG-A.
- 主要终点是病理完整反应 (pCR);次要终点包括整体存活率 (OS) 和安全性.
主要成果:
- 在接受西斯普拉丁治疗的患者中,ddMVAC-A的pCR率为58%,GC-A的pCR率为53%,36个月后的OS率分别为87%和67%.
- 在不接受西斯的患者中,PG-A的pCR率为14%,A的pCR率为32%,36个月后的OS率分别为48%和42%.
- 与治疗相关的3-4级不良事件发生在38%的患者中.
结论:
- 阿维卢马布加上基于的化疗疗法在MIBC中显示出有希望的疗效和有利的安全性,特别是在ddMVAC治疗方案中.
- 艾维卢马布单一疗法在不接受西斯普拉丁的患者中表现出令人鼓舞的活性,而PG-A疗法没有额外的益处.
- ddMVAC方案是MIBC中新辅助化学免疫治疗的潜在化疗合作伙伴,需要在第三阶段试验中进一步调查.
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