Impact of Eligibility Criteria by Race/Ethnicity in First-Line Trials of DLBCL

By: Vanessa A. Carter, BS
Posted: Monday, February 13, 2023

Matthew J. Maurer, DSc, of the Mayo Clinic, Rochester, Minnesota, and colleagues aimed to evaluate the impact of laboratory eligibility criteria from first-line diffuse large B-cell lymphoma (DLBCL) trials by race and ethnicity. Presented during the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 850), the results of this study confirmed that there is, in fact, an association between trial lab–based eligibility criteria and outcomes in newly diagnosed DLBCL, with disproportionately limited eligibility for Hispanic and non-White patients.

The investigators focused on 2,510 patients with newly diagnosed DLBCL who were enrolled in the Lymphoma Epidemiology Outcomes (LEO) cohort. All patients received CD20 antibody–based immunochemotherapy and were prospectively followed for outcomes (ie, organ function parameters, event-free survival, and overall survival).

The analysis set was composed of 2,330 patients who had three or more of the five lab-based values. Of the total, 1,972 were non-Hispanic White, and 272 were Hispanic and/or non-White; the others were of unknown race or ethnicity. Hispanic non-White patients were younger at diagnosis (P < .001) but had significantly lower hemoglobin levels (P < .001) than those identifying as non-Hispanic White.

More non-Hispanic White individuals received R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone; P < .001), but more Hispanic non-White participants were treated with combination etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (P < .001). Of note, approximately 9% to 26% of patients in the LEO cohort would have been excluded from first-line DLBCL clinical trials based on the five lab-based criteria alone, according to the investigators.

The most restrictive trials were ENGINE (ClinicalTrials.gov Identifier NCT03263026), GOYA (NCT01287741), and POLARIX (NCT03274492). Additionally, trials requiring a higher cutoff value for hemoglobin had more of an impact on the ineligibility of Hispanic and non-White populations. Furthermore, patients who were ineligible for any of these trials demonstrated a significantly inferior overall survival for both patient groups.

Disclosure: For full disclosures of the study authors, visit ash.confex.com.

2022 ASH Annual Meeting and Exposition

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