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在评估全身治疗的细胞癌试验中评估资格标准的评估

Daniela V Castro¹, Sweta R Prajapati¹, Matthew I Feng¹

¹Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.

BJU international

|August 7, 2023

概括

许多细胞癌 (RCC) 试验都排除了患有艾滋病毒或大脑转移等常见并发症的患者. 采用美国临床瘤学会 (ASCO) -癌症研究之友 (FCR) 的指导方针,可以使试验数据更具包容性,更能反映现实患者群体.

科学领域:

在瘤学瘤学.
临床试验设计临床试验设计
细胞癌研究细胞癌研究

背景情况:

临床试验的资格标准显著影响患者的纳入和结果的概括性.
细胞癌 (RCC) 试验通常具有特定的纳入/排除标准,可能会限制参与.
美国临床瘤学会 (ASCO) -癌症研究之友 (FCR) 倡议的建议旨在标准化和扩大试验资格.

研究的目的:

评估当代细胞癌 (RCC) 试验中资格标准的限制性.
评估基于特定并发病的排除频率,包括大脑转移,先前/同时恶性瘤和感染 (HIV,HBV,HCV).
将试验的限制性与ASCO-FCR建议进行比较.

主要方法:

2012年6月至2022年6月期间评估系统疗法的I-III期RCC试验的系统性审查.
识别和分类与大脑转移,先前/同时恶性瘤,HBV,HCV和HIV相关的资格标准.
标准的分层分为排除,有条件包含或未报告;频率和关联的统计分析.

主要成果:

在分析的112项试验中,观察到显著的排除率:HIV的74.1%,HBV/HCV的53.6%,大脑转移的33.0%,前/同时恶性瘤的8.0%.
在免疫疗法试验中,HIV和HBV/HCV的排除率特别高 (分别为94.4%和77.8%).
在向治疗 (36.4%) 和免疫治疗 (22.2%) 试验中,排除大脑转移是常见的.

结论:

当代RCC试验经常采用严格的资格标准,排除患有流行并发症的患者.
这些限制性标准限制了临床试验数据中真实世界患者群体的代表性.
采用ASCO-FCR建议对于提高试验包容性和将结果与临床实践保持一致至关重要.

关键词:

感染HBV/HCV的情况.艾滋病毒感染艾滋病毒感染大脑转移是大脑转移.临床试验是指临床试验中的临床试验.共同的疾病.资格标准资格标准之前或同时出现的恶性瘤.细胞癌瘤是细胞癌.

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