Kaur Manmeet, Horowitz Mary M, Mendizabal Adam, Chen Min, Foley Amy, Auletta Jeffery J, Devine Steven, D'Souza Anita
Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin.
Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin; Division of Hematology/Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.
Transplant Cell Ther. 2025 Jan;31(1):49-57. doi: 10.1016/j.jtct.2024.10.014. Epub 2024 Nov 1.
Underrepresentation by race and ethnicity in oncology clinical trials, including those of hematopoietic cell transplantation (HCT), is a known challenge. This analysis studied accrual on Blood and Marrow Transplant Clinical Trials Network (BMT CTN) trials conducted in 2014 to 2020 by race/ethnicity, age, and sex, comparing these characteristics with those of potentially eligible patients identified from the Surveillance, Epidemiology, and End Results (SEER) and Center for International Blood and Marrow Transplant Research (CIBMTR) databases for the disease, age, and years of interest of BMT CTN studies. Five BMT CTN trials met the inclusion criteria, including 1 autologous HCT trial and 4 allogeneic HCT trials. Two studies focused on multiple myeloma (BMT CTN 1302 and 1401), 2 studies focused on graft-versus-host disease (GVHD) treatment (BMT CTN 1301 and 1501), and 1 study focused on post-HCT maintenance therapy in FLT3 acute myelogenous leukemia (BMT CTN 1506). A decline in the proportion of patients from minority racial and ethnic groups was seen from the SEER population to trial enrollees, with the largest drop seen between the SEER population and all patients who underwent HCT (on or off trial) at US transplant centers. Allogeneic HCT trials that allowed alternative donor graft sources had less decrease from the SEER population. No decrease in clinical trial enrollment was seen with respect to older age and female HCT recipients. This study provides insight into the underrepresentation of racial and ethnic minority patients in BMT CTN clinical trials, owing largely to lack of access to HCT in general. Pathways expanding access to donors and improving the outreach of HCT programs to underserved populations are needed to improve access to clinical trials.
在肿瘤学临床试验中，包括造血细胞移植（HCT）试验，不同种族和族裔的代表性不足是一个已知的挑战。本分析按种族/族裔、年龄和性别研究了2014年至2020年在血液和骨髓移植临床试验网络（BMT CTN）试验中的入组情况，并将这些特征与从监测、流行病学和最终结果（SEER）以及国际血液和骨髓移植研究中心（CIBMTR）数据库中为BMT CTN研究的疾病、年龄和感兴趣年份确定的潜在合格患者的特征进行了比较。五项BMT CTN试验符合纳入标准，包括1项自体HCT试验和4项异基因HCT试验。两项研究聚焦于多发性骨髓瘤（BMT CTN 1302和1401），两项研究聚焦于移植物抗宿主病（GVHD）治疗（BMT CTN 1301和1501），一项研究聚焦于FLT3急性髓性白血病的HCT后维持治疗（BMT CTN 1506）。从SEER人群到试验入组者，少数种族和族裔群体患者的比例有所下降，在美国移植中心接受HCT（无论是否参加试验）的所有患者中，SEER人群与这些患者之间的下降幅度最大。允许使用替代供体移植物来源的异基因HCT试验与SEER人群相比下降幅度较小。在老年HCT受者和女性HCT受者方面，临床试验入组人数没有下降。本研究深入了解了BMT CTN临床试验中种族和族裔少数患者代表性不足的情况，这主要是由于总体上缺乏获得HCT的机会。需要拓展获取供体的途径，并改善HCT项目对服务不足人群的推广，以提高参与临床试验的机会。
