Exclusion of Patients Living with Chronic Viral Infections and Underrepresentation of Ethnic Minorities in Diffuse Large B-Cell Lymphoma Clinical Trials

• Published in: Blood 2020-11, Vol.136 (Supplement 1), p.36-37
• Main Authors: Boisclair, Stephanie, Uba, Richie, Brahim, Amanda, Vargas Madueno, Fernando, Chavez, Julio C., Sandoval-Sus, Jose
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2020-143226

Introduction There is a substantial underrepresentation of ethnic minorities within oncology studies. Specifically, Black, Asian and Hispanic patients have a low participation rate in US based randomized clinical trials (RCT). Furthermore, patients living with HIV (PLWH) or chronic viral hepatitis are often systematically excluded from these studies. Diffuse large B-cell lymphoma (DLBCL) is one of the most common malignancies associated with HIV and viral hepatitis. Given these characteristics, it is imperative that studies reporting on safety and efficacy of new treatments mirror real-world populations. Objective: The primary objective of our study was to describe the demographic characteristics of patients who have participated in DLBCL phase II and III randomized US clinical trials; evaluating each group's enrollment fraction compared to US DLBCL prevalence. The secondary objective was analyzing the inclusion of PLWH and chronic viral hepatitis in US based DLBCL RCT. Methods and Measures: We queried PubMed, ClinicalTrials.gov, as well as ASCO and ASH meeting abstracts for phase II and III RCTs on DLBCL from 2000 to 2020, including chimeric antigen receptor T cells (CAR-T) therapy studies. Trials that did not report race and ethnicity or recruited outside of the US were excluded. We analyzed enrollment data and compared to DLBCL prevalence demographics obtained from the SEER 18 Registries. Enrollment fraction (EF) is defined as the number of trial enrollees divided by the estimated US prevalence of DLBCL. Results: We identified 51 trials between 2000 and 2020 with only 25 (49%) studies reporting race and ethnicity. Only 9 trials enrolled solely in the US which comprised of 763 patients. Compared with an EF of 1.88% among Non-Hispanic whites, lower EF was noted in Blacks (1.08%; P=0.0009), Hispanics (0.71; P=