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对转移性细胞癌的第一线免疫疗法的非标签性使用

Hannah D McManus¹, Jessica B Long², Sarah J Westvold²

¹Department of Medicine, Duke University School of Medicine, Durham, NC.

Clinical genitourinary cancer

|April 5, 2025

概括

针对转移性细胞癌 (mRCC) 的一线免疫检查点抑制剂 (ICI) 在伴随性疾病的患者中更多地被非标签使用. 在批准后,更年轻,更健康的患者接受了第一线ICI,通常是双重治疗.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
细胞癌研究细胞癌研究

背景情况:

免疫检查点抑制剂 (ICI) 在二线 (2015) 和一线 (1L) 设置 (2018) 中获得FDA对转移性细胞癌 (mRCC) 的批准.
关于在非标签和FDA批准后期间在mRCC中使用1LICI的数据有限.

研究的目的:

在非标签和FDA批准后的阶段,分析1LICI在mRCC患者的利用情况.
在FDA批准之前和之后,确定与1LICI接收相关的人口和临床因素.

主要方法:

对被诊断患有mRCC (2015-2019) 的医疗保险受益人 (≥66岁) 的回顾性分析.
根据FDA批准日期 (2018年4月16日) 定义非标签与批准后1LICI使用.
多变量逻辑回归用于检查患者特征与1L ICI接收之间的关联.

主要成果:

确定了23,469名mRCC患者;2.4%接受了非标记的1L ICI,21%接受了批准后的1L ICI.
在非标签的1LICI使用在患有并发症 (3+条件:OR=2.00) 的患者中较高.
在批准后,年长的 (81+ vs. 66-70:OR=0.60) 和虚弱的患者不太可能接受1L ICI. 没有观察到任何显著的种族/种族差异.

结论:

最初的非标签1LICI在mRCC中的使用有利于患有并发症的患者,但这种趋势在批准后发生了转变.
在1L ipilimumab/nivolumab获批后,年轻,更健康的患者和双ICI疗法患者更有可能接受1L ICI.

关键词:

美国食品和药物管理局 (FDA) 批准我不喜欢他们,我不喜欢他们.脏癌症是什么? 脏癌症是什么尼沃卢马布的使用情况预审批预审批预审批预审批

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