Jose Trevino, MD, on Eligibility Criteria in Pancreatic Cancer Clinical Trials

"Minority patient participation in cancer clinical trials is dismal," wrote the authors of a recent study aimed at determining the impact of eligibility criteria on disparities in pancreatic ductal adenocarcinoma (PDAC) clinical trial candidacy.

The findings showed that among the 676 patients in the study, Black patients were more likely to be ineligible for participation compared with white patients (42.4% vs 33.2%, respectively) secondary to the criteria of hypoalbuminemia, hepatitis B, and hepatitis C. The researchers said that although prior cancer treatment excluded more white patients, Black patients were also numerically more likely to be ineligible because of renal dysfunction, recent coronary stenting, and uncontrolled diabetes mellitus.

"Traditional eligibility criteria differentially exclude Black patients from participating in PDAC clinical trials," said Jose G. Trevino, MD, of Virginia Commonwealth University (VCU), and colleagues, writing in the Journal of Clinical Oncology. "These criteria perpetuate disparities, limit generalizability, and are often not medically justifiable. Revised criteria may improve participant diversity, without compromising safety or study results."

In the following interview, Jose G. Trevino, MD, chair of surgical oncology at VCU and surgeon-in-chief at VCU Massey Cancer Center in Richmond, elaborates on the findings and the implications.

How severe do you consider the lack of diversity in pancreatic ductal adenocarcinoma clinical trial candidacy in the U.S.?

Trevino: The way I look at things is really simple. We've done decades of clinical trial testing in patients with pancreatic cancer. Unfortunately, about 90% of them are from white populations.

What drew you to improving PDAC trial diversity?

Trevino: As a young surgeon at the University of Florida at Gainesville, I was always baffled by the fact that we weren't seeing any Black patients with pancreatic cancer in our surgical clinics -- even though the Black and white patient populations in north-central Florida were about the same size. At one of my talks, I remember asking: "If they're not coming to our clinics, where are they going?" And a person in the audience stood up and said, "They're just dying." That's when it hit me: We have a problem, and we have to address it.

How have traditional clinical trial eligibility criteria excluded diverse patient populations?

Trevino: The higher comorbidity rates seen in patients from minority populations have excluded many from clinical trials. If we start to modify some of these "traditional" eligibility criteria just a little bit, we can even out the participation.

What else needs to change?

Trevino: We need to improve our understanding of cultural differences in patients from Black, Asian, LatinX, and American Indian populations.

What should medical oncologists be asking themselves about reducing clinical research disparities?

Trevino: When you see a patient coming through your clinic for possible clinical trial participation, do you automatically disqualify them if they have uncontrolled diabetes? Or do you send them to an endocrinologist to get the diabetes under control, and then bring the patient back?

By 2030, pancreatic cancer mortality is expected to surpass deaths from breast and prostate cancer to become the number two cancer-related cause of death in the U.S. This will continue until we focus on better ways to understand this disease.

What is the potential impact of increased clinical trial diversity on clinical care?

Trevino: Forty years ago, patients with pancreatic cancer were treated with the same therapy, no matter what. And if it didn't work, it didn't work. Now we recognize that the knowledge we gain from clinical trials in diverse populations will help us determine the best treatment for each patient. I think that's what makes this so powerful.

What would you like to say to community-based oncologists about referring patients for potential clinical trial participation?

Trevino: Referral is great, but instead of just sending your patients to an academic center, I would encourage oncologists to join the clinical trial. Partnerships are the key to building an incredible clinical trial program.

Are you reaching out to potential research partners?

Trevino: We're doing this as often and with as many people as want to collaborate with VCU. We are a safety-net hospital for a lot of patients, and sometimes we're a tertiary care center for those who can't afford care. Ultimately, we want to treat these patients, who in most cases don't get served.

Have you seen any change in the way PDAC trials are being conducted?

Trevino: The clinical studies that are coming along are no longer looking at just pancreatic cancer. They're also subtyping the disease, and the genetic mutations. Ultimately, we are going to define therapies based not only on the cancer, but also on medical history, exposures, and genetic makeup going back hundreds of years.

How far away are we from doing this?

Trevino: We're about a decade away from really defining this. I say this because at VCU we are defining genetic differences in patients with pancreatic cancer on a level that I think is innovative and significant. This includes expanding our genomic sequencing to identify molecular targets that could change the way we manage patients. We're also working with other groups around the country to classify pancreatic cancer, and we're really trying to understand the best therapeutic decisions for different classifications, such as aggressive disease.

If I could hand you a crystal ball, what would you hope to see?

Trevino: I'm hoping that 5 or 10 years from now, we will be able to look back on this study and see that clinical trial eligibility criteria have really loosened up and that more patients from diverse communities are participating.

Read the study here.