APHA Annual Meeting 2022

Poster # 923458

Session # 2017.1

Distribution of common cancer clinical trial eligibility criteria by race and ethnicity

Rossybelle P. Amorrortu, MPH¹; Yayi Zhao, MA¹; Rachel Howard, PhD²; Kedar S. Kirtane, MD³; Susan T. Vadaparampil, PhD^{4, 5},
Dana E. Rollison, PhD¹

¹Department of Cancer Epidemiology; ²Department of Health Informatics; ³Department of Head and Neck Endocrine Oncology; ⁴Office of Community Outreach, Engagement, and Equity; ⁵Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL

Introduction:

• Racial and ethnic minority patients remain underrepresented in cancer clinical trials.

• Restrictive clinical trial inclusion and exclusion criteria such as pre-existing medical conditions/comorbidities, labs, and molecular tumor markers may pose a barrier to participation among racial and ethnic minority patients because these factors may differ in terms of prevalence.

• This study aims to examine the prevalence of these factors among patients with breast cancer, lung cancer, multiple myeloma, and prostate cancer by race and ethnicity.

Methods:

• A cross-sectional analysis was conducted among patients new to the breast oncology (n=14,348), thoracic oncology (n=10,492), multiple myeloma (n=3,967), and genitourinary oncology (n=7,823) clinics at Moffitt Cancer Center (MCC) in 2011-2021.

• Data were extracted from the Moffitt Analytics Platform. Comorbidity data were available for the full cohort (n=36,630) whereas lab values and cancer characteristics varied in sample size.

  • Electronic health record: Demographics and diabetes, chronic obstructive pulmonary disease (COPD), hypertension, heart condition, organ transplant, hepatitis, human immunodeficiency virus (HIV), and abnormal lab values including neutrophils, creatinine (n=25,495), glomerate filtration rate (GFR, [n=12,191]), bilirubin (n=15,700), and aspartate aminotransferase (AST, [n=15,701])

  • Cancer Registry: History of cancer, metastasis at diagnosis (n=34,124), and triple negative status for breast cancer patients (n=7,314)

• The prevalence of these factors were compared in the four race groups (White, Black, Hispanic, and other races including Asians and multiple races) using age-adjusted logistic regression, overall and stratified by cancer type (adjusted for multiple comparisons using the Bonferroni method).

Results:

Main message: Black and Hispanic cancer patients had a higher prevalence of factors commonly included as clinical trial eligibility criteria.

• Table 1. Patient characteristics among MCC cancer patients 2011-2021.

• Figure 1. Distribution of MCC patients by cancer site.

• Figure 2. Association between the prevalence of factors commonly included as cancer clinical trial criteria and race/ethnicity.

• Figure 3. Associations between factors commonly included as cancer clinical trial criteria and race/ethnicity by cancer type. Data shown for factors with at least 5% prevalence in Figure 2.

Summary of findings:

• Minority patients were more likely to have these factors as compared to White patients:

  • Blacks: diabetes, hypertension, organ transplantation, hepatitis, HIV, triple negative breast cancer, and abnormal kidney function

  • Hispanics: diabetes, organ transplantation, hepatitis, HIV, and abnormal kidney function

  • Other race groups: diabetes

• Overall, these patterns did not vary greatly by cancer type.

Conclusions:

• It is possible that trial eligibility criteria may disproportionately impact enrollment of racial/ethnic minority patients in cancer clinical trials.

• Clinical investigators should consider these disparities when setting exclusion criteria to optimize the opportunity to participate among all patients.

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