Racial and ethnic enrollment disparities and demographic reporting requirements in acute leukemia clinical trials

Hantel, Andrew; Luskin, Marlise R.; Garcia, Jacqueline S.; Stock, Wendy; DeAngelo, Daniel J.; Abel, Gregory A.

doi:10.1182/bloodadvances.2021005148

Cited by 20 publications

(16 citation statements)

References 31 publications

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“…Disappointingly, when compared with the high proportion of Hispanic AYA ALL patients across the United States, we found that Hispanic AYAs were under-represented on CALGB 10403. While this is in keeping with other reports showing disparities in clinical trial enrollments among Hispanic patients, 16,22 - 25 we were able to demonstrate that under-enrollment was in part due to a misalignment between the geographical distribution of enrollees and the distribution of Hispanic AYA ALL patients across the United States. These findings imply that strategies to improve clinical trial enrollment among Hispanic ALL patients should include efforts to more closely align study sites and accrual projections with disease incidence patterns.…”

Section: Discussionsupporting

confidence: 91%

“…This survival disparity may be partially explained by recent evidence that ALL in patients of Hispanic ethnicity is more likely to harbor high-risk Philadelphia chromosome (Ph)-like aberrations, including gene translocations involving CRLF2 , 8,9 IKZF1 deletions, and germline polymorphisms in GATA3 . 10,11 Additional challenges disproportionately affecting Hispanic patients, such as lower socioeconomic status, 12 reduced medication adherence, 13 higher rates of obesity, 14 altered drug metabolism, 15 and low rates of clinical trial enrollment 16 also likely contribute.…”

Section: Introductionmentioning

confidence: 99%

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Disparities in trial enrollment and outcomes of Hispanic adolescent and young adult acute lymphoblastic leukemia

et al. 2022

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In this secondary analysis of Hispanic adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL) treated on Cancer and Leukemia Group B (CALGB) 10403, we evaluated outcomes and geographic enrollment patterns relative to US population data. We used demographic, clinical, and survival data on AYAs enrolled on CALGB 10403 (N = 295, 2007-2012). Surveillance, Epidemiology, and End Results registries provided overall survival (OS) for US AYA ALL by ethnicity/race. North American Association of Cancer Registries provided AYA ALL incidence overall and proportion among Hispanics by US state. Of AYAs enrolled on CALGB 10403, 263 (89%) reported ethnicity/race: 45 (17%) Hispanic, 172 (65%) non-Hispanic White (NHW), 25 (10%) non-Hispanic Black (NHB), and 21 (8%) other. Compared with NHWs, Hispanic and NHB patients had lower household income, and Hispanic patients were more likely to harbor high-risk CRLF2 aberrations. Relative to US estimates, where Hispanic patients represented 46% of newly diagnosed AYA ALL patients and experienced inferior OS compared with NHW (P < .001), Hispanic AYAs on CALGB 10403 did as well as NHW patients (3 year OS, 75% vs 74%; P = NS). Hispanic patients also had higher rates of protocol completion (P = .05). Enrollments on CALGB 10403 differed relative to the distribution of Hispanic AYA ALL in the United States: enrollment was highest in the Midwest; t and only 15% of enrollees were from states with a high proportion of Hispanic AYA ALL patients. In summary, Hispanic patients treated on CALGB 10403 did as well as NHWs and better than population estimates. Geographical misalignment between trial sites and disease epidemiology may partially explain the lower-than-expected enrollment of Hispanic AYA ALL patients.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Disparities in trial enrollment and outcomes of Hispanic adolescent and young adult acute lymphoblastic leukemia

et al. 2022

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“…22.00307 because of lower prevalence. 4,15,16 Our ClinicalTrials.gov national trial analysis found that Black, Native American, Asian, and Hispanic adults with acute leukemia were underenrolled by 51%, 56%, 36%, and 48%, respectively, 13 but data sources limited patient-or site-level assessment.…”

Section: Introductionmentioning

confidence: 99%

“…1,13 The presence, degree, and reasons for under-representation vary by cancer and trial type. 13,14 Adult acute myeloid (AML) and lymphoblastic leukemia (ALL) are aggressive but curable blood cancers with distinctive care needs that make trial enrollment processes unique: patients require therapy within days of diagnosis, treatment is frequently inpatient, substantial proportions are treated and enrolled at National Cancer Institute (NCI) Comprehensive Cancer Centers (CCCs), and reliance on multicenter studies is higher…”

Section: Introductionmentioning

confidence: 99%

Inequities in Alliance Acute Leukemia Clinical Trial and Biobank Participation: Defining Targets for Intervention

Hantel

Kohlschmidt

Eisfeld

et al. 2022

JCO

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PURPOSE Representativeness in acute leukemia clinical research is essential for achieving health equity. The National Cancer Institute's mandate for Comprehensive Cancer Centers (CCCs) to define and assume responsibility for cancer control and treatment across a geographic catchment area provides an enforceable mechanism to target and potentially remediate participatory inequities. METHODS We examined enrollee characteristics across 15 Cancer and Leukemia Group B/Alliance cooperative group adult acute leukemia clinical trials (N = 3,734) from 1998 to 2013, including participation in optional companion biobanks. We determined enrollment odds by race-ethnicity for all participants adjusted for national incidence, and for those enrolled at CCCs adjusted for catchment area incidence. We modeled biobank participation by sociodemographics using logistic regression. RESULTS Non-Hispanic (NH)-White patients were more likely to be enrolled than NH-Black, NH-Asian, or Hispanic patients (odds ratio [OR] 0.75, 0.48, and 0.44, respectively; all P < .001), but less likely than NH-Native American patients (OR 1.91; P < .001), adjusted for national incidence. Enrollment odds were lower for NH-Black, NH-Asian, and Hispanic patients at CCCs adjusted for catchment area incidence (OR 0.57, 0.26, and 0.32, respectively; P < .001); differences were driven by overenrollment of NH-White patients from outside self-defined catchment areas (18.1% v 12.3%; χ2 P = .01) and by CCCs with less absolute enrollee diversity (rank sum P = .03). Among all enrollees, NH-White race-ethnicity and lower neighborhood deprivation correlated with biobank participation (OR 1.81 and 1.45, respectively; P = .01 and .03). For CCC enrollees, the correlation of race-ethnicity with biobank participation was attenuated by a measure accounting for their site's degree of enrollment disparity but not neighborhood deprivation. CONCLUSION Acute leukemia clinical research disparities are substantial and driven by structural trial enrollment barriers at CCCs. Real-time CCC access and enrollment monitoring is needed to better align research participation with local populations.

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“…Despite optimism, ALL in adults remains a lethal disease. Ongoing trials, with representation of all racial, ethnic, and socioeconomic groups, 110 are needed to make even further dramatic improvements. This is an exciting time for adult ALL, but the best is yet to come!…”

Section: Discussionmentioning

confidence: 99%

Innovative Approaches to the Management of Acute Lymphoblastic Leukemia Across the Age Spectrum

Curran

Muffly

Luskin

2022

American Society of Clinical Oncology Educational Book

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Adults compose nearly half of all patients diagnosed with acute lymphoblastic leukemia (ALL) and historically have had poor survival compared with pediatric patients. Recently approved therapies, such as monoclonal antibodies, CAR T-cell constructs, and next-generation tyrosine kinase inhibitors, have improved survival in relapsed and refractory ALL, and studies are now examining incorporating these treatments and others into the upfront setting. In adolescent and young adult patients, use of pediatric-based regimens has already improved survival compared with historical controls, and the addition of monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, may further enhance this survival benefit. In older adults, approaches have centered on minimizing conventional chemotherapy to decrease toxicity by incorporating monoclonal antibodies and other novel therapies to increase efficacy. With the addition of tyrosine kinase inhibitors to chemotherapy for patients with Philadelphia chromosome–positive ALL, survival of this once poor-prognosis ALL subtype now approaches or exceeds outcomes of other subtypes of adult ALL. Further refinements in the backbone treatment regimen and optimal consolidation approaches will likely improve survival further. Although allogeneic hematopoietic stem cell transplant was previously routinely used as consolidation for adults with ALL, incorporation of measurable residual disease and other risk stratification strategies has enabled better identification of patients who will benefit from allogeneic hematopoietic stem cell transplant. Ongoing clinical trials investigating these approaches will continue the evolution of treatment approaches for adults with ALL, with further improvement in outcomes anticipated.

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Racial and ethnic enrollment disparities and demographic reporting requirements in acute leukemia clinical trials

Cited by 20 publications

References 31 publications

Disparities in trial enrollment and outcomes of Hispanic adolescent and young adult acute lymphoblastic leukemia

Disparities in trial enrollment and outcomes of Hispanic adolescent and young adult acute lymphoblastic leukemia

Inequities in Alliance Acute Leukemia Clinical Trial and Biobank Participation: Defining Targets for Intervention

Innovative Approaches to the Management of Acute Lymphoblastic Leukemia Across the Age Spectrum

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