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在涉及免疫治疗的膀癌临床试验中检查患者特征

Izuagie Ikhapoh^1,2, Usomine Atairu³, Amanda Jane Reich⁴

¹Department of Medical Science, Harvard Medical School, Boston, MA 02115, USA.

Journal of clinical medicine

|February 13, 2025

概括

使用免疫检查点抑制剂 (ICI) 进行的膀癌 (BC) 临床试验主要招募65岁以上的白人男性,突出显示不同患者群体的潜在代表性不足.

科学领域:

在瘤学瘤学.
临床试验设计临床试验设计
免疫治疗是一种免疫疗法.

背景情况:

了解膀癌 (BC) 临床试验中的患者人口统计数据对于有效的试验设计和解释研究结果至关重要.
免疫检查点抑制剂 (ICI) 代表了BC治疗的重大进步,需要对相关试验中的患者群体进行分析.

研究的目的:

分析参加使用ICI的BC临床试验的患者的人口特征.
确定本试验人群中患者代表性和并发症的潜在趋势.

主要方法:

对公开可用的BC临床试验数据的系统审查,该数据是在2013年至2023年之间启动的.
纳入标准侧重于使用ICI并报告关键生存终点 (PFS,OS,DFS,EFS) 的试验.
不包括评论文章和元分析.

主要成果:

总共分析了109项涉及8936名患者的试验.
患者队列主要是白种人 (96%),其中23%的患者是女性,65%的患者65岁或以上.
心血管疾病和糖尿病等并发症存在于大约30%的患者中,并在三分之一的试验中发现.

结论:

涉及ICI的BC试验的招募策略应考虑并发症对治疗疗效的影响.
调查结果表明,在BC临床试验中,某些人口群体的潜在代表性不足,与其他评论一致.
对优化试验多样性的进一步研究是有必要的,以确保ICI治疗结果的概括性.

关键词:

和伴随性疾病.膀癌:膀癌是一种癌症.人口统计数据人口统计数据免疫检查点抑制剂免疫检查点抑制剂竞争竞争竞争竞争

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