Eligibility Criteria Exclude More Blacks From Pancreatic Cancer Trials

Black patients were more likely to be excluded from pancreatic cancer clinical trials when traditional eligibility criteria were used, a cross-sectional study found.

Among individuals who sought care at a single center for pancreatic ductal adenocarcinoma (PDAC) from 2010 to 2019, traditional criteria led to more Black patients being ineligible for clinical trial participation compared with whites (42.4% vs 33.2%, P=0.023), reported Jose G. Trevino, MD, of Virginia Commonwealth University in Richmond, and colleagues in the Journal of Clinical Oncology.

Specifically, Black patients were significantly more likely to be ineligible for trial participation due to the following conditions:

• Hypoalbuminemia (OR 1.90, 95% CI 1.12-3.25)
• HIV (OR 11.30, 95% CI 1.42-89.7)
• Hepatitis C (OR 2.81, 95% CI 1.39-5.67)

In addition, prior hepatitis B infection led to the disqualification of 1.7% of Black patients compared with no white patients, as did coronary stenting within the past 6 months, which resulted in the exclusion of 1.4% of Black patients versus no whites. There were no differences in trial eligibility due to renal dysfunction (OR 1.95, 95% CI 0.87-4.38) or uncontrolled diabetes mellitus (OR 1.48, 95% CI 0.80-2.74).

While previous cancer rates were similar between Black (2.4%) and white (2.6%) patients, prior cancer treatment excluded more white than Black patients (14.0% vs 9.1%). “This was attributable to more white patients initiating neoadjuvant chemotherapy for PDAC before seeking care at Virginia Commonwealth University,” according to Trevino and colleagues.

Of note, if the criteria were revised to remove historical, controllable, or manageable medical conditions — including HIV, hepatitis C, hepatitis B, diabetes mellitus, previous cancer, and coronary stenting — this would result in similar eligibility rates for the two groups (26.8% for Black patients and 24.8% for white patients, P=0.581), the authors said.

“These criteria perpetuate disparities, limit generalizability, and are often not medically justifiable,” they wrote. “Revised criteria may improve participant diversity, without compromising safety or study results.”

“Despite a plethora of studies identifying and describing racial disparities in cancer treatment and outcomes, few offer specific, tangible solutions like those proposed here,” wrote Rebecca Snyder, MD, MPH, of East Carolina University in Greenville, North Carolina, in an accompanying editorial. “Although modifying eligibility criteria alone will not eliminate disparities, it is a practical first step that should be part of a systematic approach toward cancer health equity.”

“Each of the identified comorbidities … reflect the historical disadvantage experienced by minorities in the United States, which then amplifies downstream disparities in cancer treatment, including clinical trial representation,” Snyder observed. “Not surprisingly, the only criteria for which white patients were excluded at higher rates was receipt of prior therapy, a likely surrogate for better health care access and more favorable social determinants of health.”

“Careful consideration of the medical necessity of each criterion is needed on a trial-by-trial basis,” Trevino and his colleagues concluded. “In addition, more input from medical specialists may be indicated for the assessment of benefit versus risk for patient participation and comanagement throughout the trial. Together, these could have a profound effect on increasing eligibility of underserved populations, reducing disparities in clinical trial participation, and creating results that are more reflective of the patients that we serve.”

A total of 676 patients with PDAC were identified for this study, most of whom were Black (42.5%) or white (51.6%). About half of patients were insured by Medicare. Black patients were significantly younger that white patients (64.2 vs 67.2 years) and more likely to be women (53.3% vs 44.7%, respectively).

Almost 60% of patients had clinical stage III/IV disease, with distribution differing significantly (64.8% of Black patients vs 51.5% of white patients). Insurance coverage for Black patients also differed significantly from that of white patients, with the greatest difference attributable to Medicaid coverage (10.5% vs 4.0%, respectively) or being uninsured (10.1% vs 5.4%).