In a single-center study reported in the Journal of Clinical Oncology, Riner et al found that traditional eligibility criteria for clinical trials in pancreatic ductal adenocarcinoma excluded a higher proportion of Black vs White patients and identified factors that commonly led to exclusion.
As stated by the authors: “Clinical trials determine safety and efficacy of cancer therapeutics and establish standards of care. Minority patient participation in cancer clinical trials is dismal. We aimed to determine the impact of eligibility criteria on disparities in pancreatic ductal adenocarcinoma clinical trial candidacy.”
The study included data on 676 patients with pancreatic ductal adenocarcinoma seen at Virginia Commonwealth University (VCU) Massey Cancer Center between 2010 and 2019. Traditional pancreatic ductal adenocarcinoma trial eligibility criteria were obtained from ClinicalTrials.gov. Among patients, 287 identified as Black (42.5%) and 349 identified as White (51.6%).
Black patients were more likely to be ineligible for clinical trial participation vs White patients (42.4% vs 33.2%, P = .023), with significant differences in causes for ineligibility observed for hypoalbuminemia (14.1% vs 7.9%, P = .023), human immunodeficiency virus (HIV) infection (3.1% vs 0.3%, P = .010), hepatitis B virus (HBV) infection (1.7% vs 0%, P = .043), and hepatitis C virus (HCV) infection (9.1% vs 3.4%, P = .005).
Black patients were also numerically more likely to be ineligible due to renal dysfunction (5.7% vs 3.0%), recent coronary stenting (1.4% vs 0%), uncontrolled diabetes mellitus (8.6% vs 6.0%), prior myocardial infarction (1.7% vs 0.9%), unstable angina (3.5% vs 2.9%), and congestive heart failure (2.8% vs 2.0%).
Exclusion due to prior cancer diagnosis was similar for Black vs White patients (2.4% vs 2.6%). Prior cancer treatment excluded fewer Black vs White patients (9.1% vs 14.0%, P = .072), with this finding being attributable to a higher proportion of White patients having received neoadjuvant chemotherapy prior to being seen at VCU.
The investigators maintained that strategic eligibility criteria revisions could eliminate the significant difference in ineligibility rates between Black and White patients; revisions included removing historical, controllable, or manageable medical conditions including HIV, HCV, and HBV infection; diabetes mellitus; previous cancer; and coronary stenting. With such revisions, the proportions of Black vs White patients ineligible for trial enrollment were estimated at 26.8% vs 24.8% (P = .581).
The investigators concluded, “Traditional eligibility criteria differentially exclude Black patients from participating in pancreatic ductal adenocarcinoma clinical trials. These criteria perpetuate disparities, limit generalizability, and are often not medically justifiable. Revised criteria may improve participant diversity, without compromising safety or study results.”
Jose G. Trevino, MD, of the Division of Surgical Oncology, Virginia Commonwealth University, Richmond, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was funded by the National Cancer Institute, National Human Genome Research Institute, and Joseph and Ann Matella Fund for Pancreatic Cancer Research. For full disclosures of the study authors, visit ascopubs.org.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.