Journal article
Evaluating Lab-Based Eligibility Criteria by Race/Ethnicity in Clinical Trials of Diffuse Large B-Cell Lymphoma
Blood advances, Vol.8(16), pp.4414-4422
07/11/2024
DOI: 10.1182/bloodadvances.2024012838
PMCID: PMC11375257
PMID: 38991126
Abstract
Underrepresentation of racial and ethnic subgroups in cancer clinical trials remains a persistent challenge. Restrictive clinical trial eligibility criteria have been shown to exacerbate this problem. We previously identified that up to 24% of patients treated with standard immunochemotherapy (IC) would have been excluded from recent first-line trials in diffuse large B-cell lymphoma (DLBCL) based on 5 lab-based criteria. These ineligible patients had worse clinical outcomes and increased deaths related to lymphoma progression suggesting the potential exclusion of patients who could have benefited most from the novel therapies being evaluated. Utilizing data from the prospectively enrolled Lymphoma Epidemiology Outcomes (LEO) Cohort study, with demographics broadly similar to the U.S. patients diagnosed with lymphoma, we evaluated the impact of laboratory eligibility criteria from recent first-line DLBCL trials across various racial and ethnic backgrounds. There were significant differences in the baseline lab values by race/ethnicity with Black/African American (AA) patients having the lowest mean hemoglobin and highest creatinine clearance. Based on recent clinical trial eligibility criteria, AA and Hispanic patients had higher rates of lab-based ineligibility compared to Non-Hispanic Whites. The largest gap in the clinical outcomes between eligible (ref) and non-eligible patients was noted within AA patients with an overall survival hazard ratio based on POLARIX clinical trial criteria of 4.09, 95% CI: 1.83-9.14. A thoughtful approach to the utility of each criterion and cut offs for eligibility needs to be evaluated in the context of its differential impact across various racial/ethnic groups.Underrepresentation of racial and ethnic subgroups in cancer clinical trials remains a persistent challenge. Restrictive clinical trial eligibility criteria have been shown to exacerbate this problem. We previously identified that up to 24% of patients treated with standard immunochemotherapy (IC) would have been excluded from recent first-line trials in diffuse large B-cell lymphoma (DLBCL) based on 5 lab-based criteria. These ineligible patients had worse clinical outcomes and increased deaths related to lymphoma progression suggesting the potential exclusion of patients who could have benefited most from the novel therapies being evaluated. Utilizing data from the prospectively enrolled Lymphoma Epidemiology Outcomes (LEO) Cohort study, with demographics broadly similar to the U.S. patients diagnosed with lymphoma, we evaluated the impact of laboratory eligibility criteria from recent first-line DLBCL trials across various racial and ethnic backgrounds. There were significant differences in the baseline lab values by race/ethnicity with Black/African American (AA) patients having the lowest mean hemoglobin and highest creatinine clearance. Based on recent clinical trial eligibility criteria, AA and Hispanic patients had higher rates of lab-based ineligibility compared to Non-Hispanic Whites. The largest gap in the clinical outcomes between eligible (ref) and non-eligible patients was noted within AA patients with an overall survival hazard ratio based on POLARIX clinical trial criteria of 4.09, 95% CI: 1.83-9.14. A thoughtful approach to the utility of each criterion and cut offs for eligibility needs to be evaluated in the context of its differential impact across various racial/ethnic groups.
Details
- Title: Subtitle
- Evaluating Lab-Based Eligibility Criteria by Race/Ethnicity in Clinical Trials of Diffuse Large B-Cell Lymphoma
- Creators
- Arushi Khurana - Mayo ClinicRaphael Mwangi - Mayo ClinicLoretta J Nastoupil - The University of Texas MD Anderson Cancer CenterPatrick M Reagan - University of Rochester Medical CenterUmar Farooq - University of IowaJason T Romancik - Emory UniversityTimothy McDonnell - The University of Texas MD Anderson Cancer CenterShaun Riska - Mayo Clinic in ArizonaIzidore S Lossos - University of MiamiBrad S Kahl - Washington University in St. LouisPeter Martin - Cornell UniversityThomas E Witzig - Mayo ClinicJames R Cerhan - Mayo ClinicChristopher R Flowers - The University of Texas MD Anderson Cancer CenterGrzegorz S Nowakowski - Mayo ClinicMatthew J Maurer - Mayo Clinic
- Resource Type
- Journal article
- Publication Details
- Blood advances, Vol.8(16), pp.4414-4422
- Publisher
- ELSEVIER
- DOI
- 10.1182/bloodadvances.2024012838
- PMID
- 38991126
- PMCID
- PMC11375257
- ISSN
- 2473-9537
- eISSN
- 2473-9537
- Grant note
- National Cancer Institute: Lymphoma Epidemiology of Outcomes: U01 CA195568 University of Iowa/Mayo Clinic Lymphoma SPORE: P50 CA97274
This work was supported by grants from the National Cancer Institute: Lymphoma Epidemiology of Outcomes (U01 CA195568) and the University of Iowa/Mayo Clinic Lymphoma SPORE (P50 CA97274) .
- Language
- English
- Electronic publication date
- 07/11/2024
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Epidemiology; Internal Medicine
- Record Identifier
- 9984656612502771
Metrics
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