ABCL-248: Representation of Race, Gender, Age, HIV Status, and Treated Viral Hepatitis in Diffuse Large B-Cell Lymphoma: A Retrospective Analysis of Enrollment Demographics in Clinical Trials

Context: In cancer clinical trials, there is a low participation and significant underrepresentation of Black, Asian-American, and Hispanic patients. In Diffuse Large B-cell Lymphoma (DLBCL), the rates of new cases are equally distributed among races. DLBCL is one of the most common malignancies associated with HIV and is associated with chronic viral hepatitis. It is imperative that these groups are adequately represented to prevent ascertainment bias. Objective: To describe the representation of racial minorities, age, gender, hepatitis, and HIV status in DLBCL clinical trials. Methods and Measures: We analyzed enrollment data from randomized phase II and III trials with published results in ClinicalTrials.gov , PubMed, ASCO, and ASH from 2000 to 2020. Trials that did not report race/ethnicity or recruited outside of the U.S. were excluded. DLBCL incidence was obtained from the SEER 18 Registries. Enrollment fraction (EF) is defined as the number of trial enrollees divided by the estimated U.S. cases in each subgroup. Results: We identified 48 trials between 2000 and 2020, with 22 (46%) studies reporting race/ethnicity. Only 6 trials enrolled solely in the U.S, comprising 624 patients. Compared with an EF of 1.53% among Non-Hispanic whites, lower EF was noted in Blacks (0.94%; P=0.006), Hispanic (0.63%; P Conclusions: Ethnic minorities, HIV patients, and females were significantly less represented compared to non-Hispanic whites, non-HIV patients, and males. Given the substantial cancer burden borne by ethnic minorities, HIV, and females, adequate representation of these populations is necessary in clinical trials. Patients with controlled HIV and/or treated viral hepatitis should be included in cancer trials. Reasons for under-enrollment in trials are complex and multifactorial, including lack of access, increased burden of comorbidities, and mistrust of the healthcare system. A substantial way to ameliorate these inequalities is by improving healthcare literacy, spearheaded by all key stakeholders involved.