A quantitative synthesis of disparities in the inclusion of racial/ethnic minorities and older adults in prostate cancer clinical trials over the last three decades.

Authors

null

Irbaz Bin Riaz

Dana-Farber Cancer Institute, Boston, MA

Irbaz Bin Riaz , Mahnoor Islam , Waleed Ikram , Syed Arsalan Ahmed Naqvi , Hamza Maqsood , Yusra Saleem , Anum Riaz , Praful Ravi , Syed A. Hussain , Jeremy Lyle Warner , Folakemi Odedina , Narjust Duma , Parminder Singh , Alan Haruo Bryce

Organizations

Dana-Farber Cancer Institute, Boston, MA, Dow University of Health Sciences, Karachi, Pakistan, Mayo Clinic, Phoenix, AZ, Nishtar Medical University, Multan, Pakistan, Dow Medical College, Karachi, Pakistan, Midwestern University GME Consortium, Glendale, AZ, University of Sheffield and Sheffield Teaching Hospitals, Sheffield, United Kingdom, Vanderbilt-Ingram Cancer Center, Nashville, TN, Mayo Clinic, Jacksonville, FL, Mayo Clinic, Rochester, MN

Research Funding

No funding received

Background: The underrepresentation of minority populations in clinical trials negatively impacts cancer and widens inequities. We aimed to quantify the enrollment disparities in prostate cancer (PC) clinical trials over the last three decades. Methods: MEDLINE and Embase were searched to identify primary reports of prostate cancer RCTs (1989-2020). Data for trial characteristics, the proportion of trials reporting race, ethnicity and age, and the proportion of patients by race, ethnicity and age enrolled in trials were summarized using descriptive statistics. Enrollment incidence ratios (EIR), which compare trial enrollment against global estimates of incidence in age-related subgroups (acquired from the Global Burden of Disease database) and U.S. population-based estimates of racial/ethnic subgroups (acquired from the SEER 18 incidence database) were calculated. Individual trial EIRs were pooled using random-effects meta-analyses to account for the substantial heterogeneity between trials. Multivariable meta-regression was used to explore associations between key trial characteristics and EIR. Annual percentage changes (APC) over the last three decades in enrollment disparities were analyzed using the Joinpoint Regression Analysis. Results: 281 trials from 1989 to 2020 with 99,588 patients were included in this analysis. 107 trials reported race (38%), of which only 25 trials (9%) reported data on all 5 U.S. racial categories (Black, White, Asian, Pacific Islander and Native American. 255 (91%) trials reported mean or median but only 71 trials (25%) specifically reported the enrollment proportion of older adults (age > 65 years). Clinical outcomes by race and age were reported in 9 (8%) and 37 (14%) trials, respectively. Results from meta-analyses showed that Black patients (summary EIR: 0.42 [95% CI: 0.35 - 0.51]), Hispanics (summary EIR: 0.50 [95% CI: 0.37 - 0.68]) and older adults (summary EIR: 0.95 [95% CI: 0.91 - 0.99]) were underrepresented in trials relative to their population estimates. Significantly fewer Black participants (EIR for Black patients = 0.42, EIR for White patients = 0.99; p < 0.0001), Hispanic participants (EIR for Hispanics = 0.50, EIR for non-Hispanics = 1.00; p = 0.001) and older adults (EIR for older adults = 0.95, EIR for younger adults = 1.06; p = 0.037) were enrolled. Representation of Black patients decreased significantly from 1989-2019 (APC: -4.25), while Hispanic representation increased significantly from 2000-2020 (APC: 5.89). Meta-regression showed Black patients were particularly underrepresented in larger-size trials (p < 0.0001). Conclusions: Black representation in PC clinical trials is less than 50% of their expected share based on cancer incidence and it has consistently decreased over last three decades, contributing to the disparities experienced by the population.

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Abstract Details

Meeting

2022 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Prostate Cancer

Track

Prostate Cancer - Advanced,Prostate Cancer - Localized

Sub Track

Cancer Disparities

Citation

J Clin Oncol 40, 2022 (suppl 6; abstr 26)

DOI

10.1200/JCO.2022.40.6_suppl.026

Abstract #

26

Poster Bd #

N1

Abstract Disclosures

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