Black patients less likely to meet eligibility criteria for pancreatic cancer trials
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Standard eligibility criteria for pancreatic cancer clinical trials differentially exclude Black patients from participation, according to results of a simulated screening process.
The findings, presented during the American Association for Cancer Research Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, demonstrated that these common trial enrollment criteria limit generalizability of results and may not be medically justifiable, according to researchers.
“Creating universal guidelines based on the investigation of therapeutics in participants from the same subpopulation is really inappropriate and lacks generalizability. This lack of diverse and equitable representation may be contributing to disparities in survivorship,” Andrea N. Riner, MD, MPH, research fellow and general surgery resident at University of Florida, said during the presentation.
“What’s really troubling about this is that Black and Hispanic patients were enrolled at a rate of approximately 40% of what would be expected based on their incidences of pancreatic cancer,” Riner added. “Therefore, standards of care and safety data are based upon the study of new therapeutics in predominantly non-Hispanic white patients.”
Riner and colleagues set out to determine the magnitude of the impact of eligibility criteria on disparities in pancreatic cancer clinical trial candidacy.
The researchers designed a retrospective study simulating the clinical trial screening process among a representative sample of patients with pancreatic ductal adenocarcinoma who received care at VCU Massey Cancer Center from 2010 to 2019. They compiled a list of common eligibility criteria based on sampling phase 2 and phase 3 trials that were active enrolling in March of 2021.
Researchers identified 676 patients (mean age, 65.9 years; 51.9% men) and included 636 in the final analysis, focusing on the non-Hispanic white and Black patients who made up most of the cohort.
Results showed Black patients were more likely to be ineligible for participation than white patients (42% vs. 33.3%, P = .039) after applying all criteria.
Black patients were significantly more likely to be deemed ineligible based on creatinine (6.08% vs. 2.27%, P = .036), HIV (3.136% vs. 0.286%, P = .01), hepatitis B (1.742% vs 0%, P = .043) and hepatitis C (9.06 vs 3.43%, P = .005). They also appeared more likely to be ineligible based on albumin (12.45% vs. 7.47%), history of coronary stenting in the past 6 months (1.39% vs. 0%) and uncontrolled diabetes (8.96% vs. 6.07%), although researchers noted the differences did not achieve statistical significance at the 5% level.
The only criteria that excluded more white patients was history of prior cancer treatment (14% vs. 9.05%).
“Interestingly, the rates of prior cancer diagnosis within 3 years of their current pancreatic cancer were similar across groups; however, white patients tended to be more likely to have received prior cancer treatment,” Riner said. “This difference between prior cancer and prior cancer treatment correlated with patients receiving neoadjuvant therapy for their current pancreatic cancer prior to seeking care at VCU. These differing rates of prior treatment between Black and white patients suggest differential access to and utilization of care.”
The study was limited by its use of data from a single institution and of patients who identified as either Black or white, although Riner said researchers suspect their results may be applicable to other minority groups.
Although more research is needed, Riner said the current findings could be used to inform alterations to existing eligibility requirements in clinical trial enrollment.
“Modifications should be made on a trial-by-trial basis given the range of therapeutics being investigated. These decisions could be made between the sponsor of the trial and an advisory board of medical experts that would be able to decide which criteria are absolutely necessary,” Riner said in a press release. “Alternative eligibility criteria can improve the diversity of participants, provide more equitable access to investigational therapeutics and reduce disparities in survivorship without compromising patient safety or study results.”
References:
Riner AR, et al. Presented at: American Association for Cancer Research Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved (virtual conference); Oct. 6-8, 2021.
Some pancreatic cancer clinical trial eligibility criteria may be more likely to disqualify Black patients. https://www.aacr.org/about-the-aacr/newsroom/news-releases/some-pancreatic-cancer-clinical-trial-eligibility-criteria-may-be-more-likely-to-disqualify-black-patients/. Published Oct. 6, 2021. Accessed Oct. 8, 2021.
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Riner AR, et al. Presented at: American Association for Cancer Research Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved (virtual conference); Oct. 6-8, 2021.
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