Loeb Nathalie, Katsnelson Olivia, Jain Anshika, Tahvildar Parsa, Teitelbaum Daniel, Garcia-Horton Alejandro
Department of Internal Medicine, McMaster University, Hamilton, ON, Canada.
Faculty of Health, York University, Toronto, ON, Canada.
Blood Neoplasia. 2025 Jan 22;2(2):100070. doi: 10.1016/j.bneo.2025.100070. eCollection 2025 May.
There are significant racial and ethnic disparities in the incidence and survival of patients with acute myeloid leukemia (AML). Understanding the discrepancies in enrollment in randomized controlled trials (RCTs) is important for better informing access to care and clinical trial conduct. We systematically reviewed the literature on the enrollment of racial/ethnic minorities and older adults into RCTs of AML. MEDLINE was searched from inception through June 2023 for RCTs on disease-modifying therapy for AML in adults. The proportion of trials reporting racial and ethnic subgroups, the enrollment proportions for each race, and age ≥65 years were determined, which were stratified by year, trial phase, and geographic location. A meta-analysis of enrollment incidence ratios (EIRs), the ratio of trial proportions of members of a racial and ethnic subgroup divided by the US population-based incidence, was conducted. A total of 7759 titles and abstracts and 157 full texts were screened, yielding 90 studies. Up to 23.3% of trials reported race or ethnicity, and 28.9% reported age ≥65 years. Of the trials reporting race, 4.7% of participants were Black, 9.8% Asian/Pacific Islander, 0.5% Native American/Alaska Native, 80.8% White, and 3.4% Hispanic. Hispanic patients (EIR, 0.28), and Asian patients (EIR, 0.16) were significantly underrepresented, whereas White patients (EIR, 1.23) were significantly overrepresented. When stratifying by year, we found an increase in the proportion of trials reporting on race in the last 10 years (46.2% vs 19.5%) and an increase in the last 20 years in the proportion of racial minorities enrolled.
急性髓系白血病（AML）患者的发病率和生存率存在显著的种族和民族差异。了解随机对照试验（RCT）入组情况的差异对于更好地了解医疗服务的可及性和临床试验的开展非常重要。我们系统回顾了关于种族/民族少数群体和老年人纳入AML随机对照试验的文献。检索MEDLINE数据库，从创建至2023年6月，查找关于成人AML疾病修饰疗法的随机对照试验。确定报告种族和民族亚组的试验比例、每个种族的入组比例以及年龄≥65岁的比例，并按年份、试验阶段和地理位置进行分层。对入组发病率比（EIR）进行荟萃分析，即种族和民族亚组成员的试验比例除以美国基于人群的发病率。共筛选了7759篇标题和摘要以及157篇全文，得到90项研究。高达23.3%的试验报告了种族或民族，28.9%的试验报告了年龄≥65岁。在报告种族的试验中，4.7%的参与者为黑人，9.8%为亚裔/太平洋岛民，0.5%为美洲原住民/阿拉斯加原住民，80.8%为白人，3.4%为西班牙裔。西班牙裔患者（EIR，0.28）和亚裔患者（EIR，0.16）的代表性明显不足，而白人患者（EIR，1.23）的代表性明显过高。按年份分层时，我们发现过去10年报告种族的试验比例有所增加（46.2%对19.5%），过去20年种族少数群体的入组比例也有所增加。
