Identifying eligibility criteria that perpetuate race/ethnic disparities in acute myeloid leukemia (AML) clinical trial participation.
Authors: Andrew Hantel, Yating Wang, Ivy Abraham, Anand Ashwin Patel, Sarah Elizabeth Monick, Garth H Rauscher, Ana Maria Avila Rodriguez, Carlos Galvez, Peter Doukas, Jessica K. Altman, Madelyn Burkart, Amani Erra, Maryam Zia, Melissa L. Larson, Ami Atulkumar Dave, Stephanie Tsai, Ahmed Aleem, Nepheli Raptis, Irum Khan, Gregory A. Abel
Journal: Journal of Clinical Oncology (2024)

1589 Background: The extent to which eligibility criteria perpetuate race/ethnic disparities in adult AML clinical trial participation is unknown. Methods: This multicenter cohort study counterfactually assessed race/ethnic disparities in trial eligibility between Non-Hispanic Whites (NHW) and Minoritized Individuals (MI: Hispanic, Black, Asian, and/or Other) diagnosed with AML between 2010-2022 at six hospitals in Chicago, IL and one in Boston, MA. All newly diagnosed patients were catalogued; those with complete data were analyzed. Eligibility criteria were obtained from 190 front-line phase II/III therapeutic studies active during the same period (1). Common sets of criteria for intensive and non-intensive trials were generated based on prevalent criteria and medians of any associated limits (e.g., QTc ≤480 ms). Proportions of MI and NHW that would have been eligible based on these common criteria sets were assessed using X 2 tests with odds ratios (OR). Mann-Whitney U tests assessed differences in the median number of trials for which each MI and NHW patient would have been eligible. Analyses with MI groups disaggregated were also performed. Results: There were 1283 patients (405 MI, 878 NHW) with a median age of 60 years (57 MI, 61 NHW; p&lt;0.001); 44% were female. According to the common set of 23 intensive trial criteria that was generated, similar proportions of MI and NHW were eligible (24.7% and 24.5%, OR 1.01, 95% CI [0.77,1.33]). With the age limit criterion removed, fewer MI than NHW were eligible (42.7% and 36.0%, OR 0.76, 95% CI [0.59,0.96]). In this set of criteria, prior malignancy (excluding 22.5% and 17.5%, p=0.04), prolonged QTc (17.0% and 8.7%, p&lt;0.001), and coronary artery disease (CAD; 8.6% and 4.1%, p=0.002) generated the largest disparity individually. According to the non-intensive set (14 criteria), fewer MI were eligible than NHW (42.2% and 54.4%, OR 0.61, 95% CI [0.48,0.78]); there was no age criterion in this set. Prior malignancy (22.5% and 17.5%, p=0.04), prolonged QTc (20.5% and 12.8%, p&lt;0.001), and hepatitis B infection (4.0% and 1.0%, p=0.001) generated the largest disparities in this set. Overall, individuals were eligible for a mean of 51.6% of the 190 trials (median: 98 trials, IQR [59,115]). MI were eligible for 6.8% fewer trials than NHW (median difference: 13 trials [88 and 101], p&lt;0.001). Asian, Black, and Other were eligible for 7.7%, 4.8%, and 16.9% less trials than NHW, respectively (all p&lt;0.05). Criteria with the largest individual disparities in median eligibility were lower age limits, hepatitis B, and CAD (all p&lt;0.01). Conclusions: Eligibility criteria disparately exclude minoritized individuals from AML clinical trial participation. Based on ASCO recommendations ( 2), several of the criteria driving disparate eligibility (hepatitis, prior malignancy) are modifiable or removable. 1. Hantel, Haematologica, 2023. 2. ASCO, Clin Cancer Res, 2021.