Abstract 5538: Prevalence of factors serving as common cancer clinical trial eligibility criteria by race and ethnicity
Authors: Zhao Yayi , Amorrortu Rossybelle P. , Howard Rachel , Kirtane Kedar S. , Vadaparampil Susan T. , Rollison Dana E. 
Published: April 2023

Background: Racial/ethnic minority patients remain underrepresented in clinical trials potentially due to restrictive trial eligibility criteria that disproportionally affect minority cancer patients.

Objective: To examine the prevalence of existing medical conditions and abnormal lab values that commonly serve as clinical trial eligibility criteria among cancer patients by race and ethnicity.

Methods: A cross-sectional analysis was conducted among patients new to Moffitt Cancer Center in 2011-2021 with multiple myeloma (n=3,967), breast (n=14,348), lung (n=10,492), and prostate (n=7,823) cancers. Demographics, existing medical conditions, and lab values were obtained from the Electronic Health Record, whereas history of cancer and metastatic disease at diagnosis were obtained from the Cancer Registry. Prevalence of medical conditions and abnormal lab values were reported among all patients and compared by race groups (White, Black, Hispanic, and other races) using age-adjusted logistic regression. For factors with prevalence higher than 5%, stratified analysis was conducted with respect to cancer type and adjusted for multiple comparisons.

Results: Compared to White patients, Black (B) and Hispanic (H) patients were found to have higher prevalence of diabetes (OR [odds ratio] = 2.26 [B]/1.40 [H]), organ transplantation (OR=1.58 [B]/1.77 [H]), hepatitis (OR=1.74 [B]/1.48 [H]), HIV (OR=4.25 [B]/1.92 [H]), and abnormal creatinine value (OR=1.77 [B]/1.23 [H]). In addition, Black patients were more likely to have hypertension (OR=1.41) while patients of other races were more likely to be diabetic (OR=1.36). Similar patterns were observed across cancer types.

Conclusion: Restrictive cancer clinical trial eligibility criteria may post a structural barrier that disproportionately impact racial/ethnic minority patients. Investigators should consider leveraging real-world data to define and design appropriate trial eligibility criteria.

Prevalence of factors commonly included as clinical trial eligibility by race/ethnicity. Factors All White Black Hispanic Other Prevalence (%) % % OR (95% CI) % OR (95% CI) % OR (95% CI) Diabetes 6.30 5.90 10.00 2.26 (1.97-2.58) 6.50 1.40 (1.20-1.63) 6.50 1.36 (1.07-1.70) Chronic obstructive pulmonary disease 10.30 11.40 6.20 0.61 (0.52-0.72) 6.10 0.61 (0.52-0.71) 5.90 0.57 (0.44-0.72) Hypertension 18.00 18.50 19.80 1.41 (1.27-1.55) 13.40 0.87 (0.78-0.97) 13.50 0.84 (0.71-1.00) Heart condition 3.00 3.10 2.60 1.10 (0.86-1.39) 2.00 0.80 (0.61-1.03) 1.80 0.70 (0.44-1.05) Organ transplant 0.90 0.90 1.40 1.58 (1.11-2.20) 1.50 1.77 (1.28-2.41) 0.40 0.46 (0.16-1.00) Autoimmune disease 2.50 2.60 2.10 0.84 (0.63-1.09) 1.90 0.78 (0.59-1.01) 2.20 0.90 (0.60-1.30) Hepatitis 0.70 0.70 1.20 1.74 (1.17-2.49) 1.00 1.48 (0.99-2.15) 0.40 0.60 (0.21-1.30) HIV infection 0.30 0.20 0.90 4.25 (2.62-6.74) 0.40 1.92 (1.01-3.40) 0.20 0.71 (0.12-2.30) History of any cancer 15.90 17.20 10.30 0.69 (0.60-0.78) 10.30 0.69 (0.61-0.77) 10.90 0.71 (0.59-0.85) Metastasis at diagnosis 21.20 21.40 22.60 1.13 (1.02-1.24) 19.80 0.96 (0.87-1.05) 18.60 0.88 (0.75-1.02) Abnormal neutrophil count 19.70 20.10 20.20 1.00 (0.86-1.16) 16.60 0.79 (0.67-0.93) 18.20 0.89 (0.69-1.13) Abnormal creatinine 14.00 13.50 19.30 1.77 (1.57-1.99) 14.10 1.23 (1.08-1.39) 13.40 1.13 (0.93-1.38) Abnormal glomerular filtration rate 14.00 13.50 22.40 2.32 (1.99-2.70) 11.20 1.07 (0.88-1.30) 10.10 0.91 (0.66-1.22) Abnormal bilirubin 2.40 2.50 2.40 1.02 (0.69-1.45) 2.40 1.03 (0.70-1.46) 2.40 0.99 (0.52-1.69) Abnormal aspartate aminotransferase 9.40 9.40 9.20 0.88 (0.72-1.07) 9.70 0.92 (0.76-1.12) 8.50 0.82 (0.59-1.12)

Citation Format: Yayi Zhao, Rossybelle P. Amorrortu, Rachel Howard, Kedar S. Kirtane, Susan T. Vadaparampil, Dana E. Rollison. Prevalence of factors serving as common cancer clinical trial eligibility criteria by race and ethnicity. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5538.