|The following article features coverage from the 2021 AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
Standard eligibility criteria for pancreatic cancer trials exclude Black patients more often than White patients, according to research presented at the 2021 AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved.
These criteria perpetuate racial disparities, limit generalizability to real-world clinical scenarios, and are often not medically justifiable, said Andrea N. Riner, MD of the University of Florida College of Medicine in Gainesville, when presenting the research at the meeting.
Dr Riner cited recent data showing that non-White and non-Hispanic patients continue to be underrepresented in pancreatic cancer trials.2 She pointed out that the prevalence of infectious and chronic diseases that often exclude patients from trials differs between populations, with racial and ethnic minority groups often being disproportionately affected.
Although the American Society of Clinical Oncology and Friends of Cancer Research have recommended updating trial eligibility criteria to increase participation among patients with comorbidities,3 the impact of eligibility criteria on the enrollment of diverse participants remains unknown.
To gain some insight, Dr Riner and colleagues conducted a retrospective study simulating the clinical trial screening process. For the simulation, the researchers used common eligibility criteria for phase 2 and 3 pancreatic cancer trials listed on ClinicalTrials.gov.
The researchers applied these criteria to “screen” 636 patients with pancreatic ductal adenocarcinoma who received care at VCU Massey Cancer Center in Richmond, Virginia, from 2010 to 2019. The analysis was limited to non-Hispanic Black and non-Hispanic White patients.
The researchers found that Black patients were significantly more likely than White patients to be deemed ineligible for trials based on the following criteria (P <.05 for all):
- Albumin level below 3.0 g/dL — 14.1% of Black patients were ineligible, compared with 7.9% of White patients
- HIV — 3.1% of Black patients were ineligible, compared with 2.9% of White patients
- Hepatitis B — 1.7% of Black patients were ineligible, compared with 0% of White patients
- Hepatitis C — 9.1% of Black patients were ineligible, compared with 3.4% of White patients.
Black patients were also more likely to be deemed ineligible due to uncontrolled diabetes, coronary stenting in the last 6 months, and impaired renal function (creatinine >1.5 mg/dL or creatinine clearance <30 mL/min/1.73 m2). However, the differences between Black and White patients were not statistically significant for these 3 criteria.
The only criterion that excluded fewer Black patients than White patients was prior cancer treatment, but this difference was not statistically significant. The difference was attributed to more White patients initiating neoadjuvant therapy for their pancreatic cancer before seeking care at VCU.
When taken together, the eligibility criteria made 42.4% of Black patients ineligible for trial enrollment, compared with 33.2% of White patients (P =.0226).
Based on the study’s results, Dr Riner and colleagues proposed alternative eligibility criteria that might allow more Black patients to enroll on pancreatic cancer trials. Specifically, the researchers recommended changing the creatinine cutoff to 2.0 mg/dL and the creatinine clearance to 30 mL/min/1.73 m2 or above.
The researchers also recommended removing the following variables from eligibility criteria (with conditions): uncontrolled diabetes, hepatitis B and C, HIV, prior cancer, and coronary stenting within the last 6 months.
Dr Riner said prior cancer shouldn’t necessarily exclude patients from trials, as long as they are not on active treatment for that cancer. Similarly, rather than excluding patients with HIV, treatment could be modified to prevent drug-drug interactions.
Furthermore, patients with coronary stenting within the last 6 months could still be included in trials if they are asymptomatic, with preserved cardiac function, and receive clearance from a cardiologist, Dr Riner said.
When Dr Riner and colleagues applied these alternative criteria to the patients studied, similar proportions of Black and White patients were ineligible for trial participation — 26.8% and 24.8%, respectively.
“Our proposed alternative criteria may not be appropriate for every trial, but these findings really should lead to careful consideration of the necessity of each criterion, as alternative criteria have the potential to improve representation of diverse participants and the generalizability of study results as well as provide more equitable access to investigational therapeutics and reduce disparities in survivorship, all without compromising patient safety or study results,” Dr Riner said.
- Riner AN, Girma S, Skoro N, et al. Eligibility criteria perpetuate disparities in enrollment and participation in pancreatic cancer clinical trials. Presented at: AACR 2021 Virtual Cancer Health Disparities; October 6-8, 2021. Abstract PR-09.
- Herremans KM, Riner AN, Winn RA, Trevino JG. Diversity and inclusion in pancreatic cancer clinical trials. Gastroenterology. Published online August 17, 2021. doi:10.1053/j.gastro.2021.06.079
- Kim ES, Bruinooge SS, Roberts S, et al. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research joint research statement. J Clin Oncol. 2017;35(33):3737-3744. doi:10.1200/JCO.2017.73.7916