Dr. Andrew Hantel is an AML expert from Dana-Farber Cancer Institute whose research focuses on investigating and advancing ethical issues of scarce resource allocation in hematology/oncology through patient-centered health services research methods. His research seeks to incorporate patient and physician perspectives into topical ethical dilemmas, thereby informing practice and policy

He shared his oral abstract Race-Ethnic Enrollment Disparities over 15 Years of Alliance/CALGB Acute Myeloid Leukemia Clinical Trials, Biobanks, and Correlative Science Protocols and visited with us afterward to explain the study and his findings.

Some of the work Dr. Hantel has been doing over the past few years has focused on looking at aspects of health equity for patients with AML which includes differences in outcomes for patients by race and ethnicity and looking at differences within patients from different backgrounds who enroll in clinical trials. The study Dr. Hantel discusses today looked back at 15 AML clinical trials that recruited patients with AML over the past 20 years all around the United States. He analyzed data based on various demographics of patients and looked at how they were enrolled onto clinical trials and companion studies which are studies that ask patients to provide blood and bone marrow samples to help inform bigger questions about how patients respond to different treatments as well as to provide an understanding as to how treatments works against specific genetic mutations and chromosomes abnormalities found in AML. Incidence and prevalence of AML were examined to look at differences of all patients AML compared to those intvolved in clinical trials focusing on race and ethnicity, ultimately comparing who is affected with AML to who is actually included in clinical trials.

Main Takeaways from the Trial 

Non-hispanic white patients were involved in clinical trials at a rate of 2:1 compared to other racial groups which included Hispanics, non-Hispanic Blacks, non-Hispanic Asians and non-Hispanic Native American patients. Interestingly enough, a few sites enrolled patients onto these trials that have a good focus on indigenous and tribal health, so those two sites ended up overenrolling Native American patients relative to non-Hispanic white patients. Dr. Hantel proposes that researchers can learn from these two centers to learn what's being done different to get specific minorities more involved and make clinical trial participation more diverse.

Researchers have seen these types of disparities in other studies done in the past so they looked look at the National Cancer Institute Comprehensive Cancer Centers which make up about 60% of trial enrollment. These centers are also large academic centers that treat a lot of AML patients. This is different from other solid cancer tumors or even other blood cancers because when patients have AML the commonness is very low so many doctors are uncomfortable treating them so patients are often referred to go see AML experts at these larger Comprehensive Cancer Centers. I analyzing these centers to more local centers, and unfortunately the disparities at these Comprehensive Cancer Centers was even worse. There was a bout a 30% chance of enrollment for diverse groups at these centers compared to non-Hispanic Whites. 

Next Steps to Work to Minimize Clinical Trial Enrollment Disparities

Dr. Hantel states that the next steps are to try to better understand what are the mediators and barriers to more diverse enrollment and why is this difference major difference happening. Is it access? Is it minorities at these centers just not getting into trials? These are the questions that his next set of work will attempt to answer. 

The good news is that when looking at biobank trials or tissue collection studies, if a patient was enrolled into a trial, over 90% were participating in tissue collection which is higher than what is seen in solid tumors. He believes this may be due to the fact that it is easier to obtain samples from leukemia patients vs other cancers becuase the leukemia is circulating in the blood and blood can be collective very easily.

On the other hand, for correlative science studies which refers to studies done during clinical trials to answer additional questions that relate to the trial revealed disparities in enrollement even among people who were accepted onto the trial. This is a big issue because correlative science helps to dictate how we are doing drug discovery and drug developement because substudys are needed to further understand how the drug acts in specific populations. It begs the questions of who are we missing, why is this treatment not working and how to make it better? Disparities are not only affecting the current set of AML trials but also that because there are disparities within these correlative companion studies were making drugs that are better for the specific people included in the study but not necessarily for all people with AML.

Moving forward Dr. Hantel is working with larger cancer registries to look deeper on a patient level to determine what the barriers are that stop diverse groups from enrolling in clinical trials. It's his hope that to take a look at what’s going on right now vs looking to the past so that we can actively and quickly make interventions that improve things for all AML patients. A major strategy may be to discuss directory with doctors about what they are doing well and inform them on what they can do better as well as reach out to the centers that are doing well with diverse enrollment so they can teach the centers that require improvement.

Interested in hearing more from Dr. Hantel?

He will be participating in an Adult AML chapter virtual event with us on March 23rd, 2022 at 4 PM Eastern to discuss the importance of diversity in AML clinical trials and how we as patients can become more involved in advancing AML research. Join our newsletter or Facebook groups to be alerted with the registration page for this event is available.