癌症临床试验中种族和民族亚组的代表性不足仍然是一个持续存在的挑战。限制性临床试验资格标准已被证明加剧了这一问题。我们之前发现，根据 5 项实验室标准，高达 24% 接受标准免疫化疗 (IC) 治疗的患者被排除在最近的弥漫性大 B 细胞淋巴瘤 (DLBCL) 一线试验之外。这些不符合条件的患者的临床结果更差，并且与淋巴瘤进展相关的死亡人数增加，这表明可能会排除那些可能从正在评估的新疗法中获益最多的患者。利用前瞻性入组的淋巴瘤流行病学结果 (LEO) 队列研究的数据（人口统计数据与美国诊断为淋巴瘤的患者大致相似），我们评估了近期一线 DLBCL 试验的实验室资格标准对不同种族和民族背景的影响。不同种族/民族的基线实验室值存在显着差异，黑人/非裔美国人 (AA) 患者的平均血红蛋白最低，肌酐清除率最高。根据最近的临床试验资格标准，与非西班牙裔白人相比，AA 和西班牙裔患者的实验室不合格率更高。符合条件（参考）和不符合条件的患者之间临床结果的最大差距出现在 AA 患者中，根据 POLARIX 临床试验标准，总体生存风险比为 4.09，95% CI：1.83-9.14。需要根据其对不同种族/民族群体的不同影响，对每个标准的效用和资格界限进行深思熟虑的评估。版权所有 © 2024 美国血液学会。

Underrepresentation of racial and ethnic subgroups in cancer clinical trials remains a persistent challenge. Restrictive clinical trial eligibility criteria have been shown to exacerbate this problem. We previously identified that up to 24% of patients treated with standard immunochemotherapy (IC) would have been excluded from recent first-line trials in diffuse large B-cell lymphoma (DLBCL) based on 5 lab-based criteria. These ineligible patients had worse clinical outcomes and increased deaths related to lymphoma progression suggesting the potential exclusion of patients who could have benefited most from the novel therapies being evaluated. Utilizing data from the prospectively enrolled Lymphoma Epidemiology Outcomes (LEO) Cohort study, with demographics broadly similar to the U.S. patients diagnosed with lymphoma, we evaluated the impact of laboratory eligibility criteria from recent first-line DLBCL trials across various racial and ethnic backgrounds. There were significant differences in the baseline lab values by race/ethnicity with Black/African American (AA) patients having the lowest mean hemoglobin and highest creatinine clearance. Based on recent clinical trial eligibility criteria, AA and Hispanic patients had higher rates of lab-based ineligibility compared to Non-Hispanic Whites. The largest gap in the clinical outcomes between eligible (ref) and non-eligible patients was noted within AA patients with an overall survival hazard ratio based on POLARIX clinical trial criteria of 4.09, 95% CI: 1.83-9.14. A thoughtful approach to the utility of each criterion and cut offs for eligibility needs to be evaluated in the context of its differential impact across various racial/ethnic groups.Copyright © 2024 American Society of Hematology.