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Disparities Among Cancer Patients Seen in Gaps in Clinical Trial Participation

Neff Newitt, Valerie

doi: 10.1097/01.COT.0000654700.58384.e2
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Hala Borno, MD
Hala Borno, MD:
Hala Borno, MD

All men are not created equal in the world of cancer. That is one message from Hala Borno, MD, PhD, a medical oncologist focusing on genitourinary malignancies at the UCSF Helen Diller Family Comprehensive Cancer Center. “I have a research interest in addressing disparities, the reflection of differences that lead to inequity,” she told Oncology Times.

An area that she pays particular attention to is disparities among clinical trial participants. “We know black men are approximately two times more likely to develop prostate cancer and die from this disease. Black men also are more likely to present with advanced prostate cancer. Yet black men are underrepresented in our therapeutic clinical trials,” she detailed. “This has been seen on a national and international level. I'm particularly interested in the drivers of such disparities in trial participation.”

How, exactly, are such inequalities unearthed? Borno said one of the critical questions to ask when trying to discover if inequity exists is to first look at population level trends and determine where there are needs and where there are differences.

“For example, one thing you can observe when you look at National Cancer Registry data is that black men are overrepresented in the population of patients with advanced prostate cancer relative to their population in the U.S. When you look at mortality, again you see that black men have increased rates of mortality compared to their white counterparts related to this disease. This suggests to me that there's a critical problem,” noted Borno.

“Then the question is, ‘What is driving this problem?’ Part of my research is to unpack whether or not these are socioeconomic factors and to understand the role of biology in contributing to disparities that we're observing,” she offered. “When we adjust for socioeconomic status, we're still observing these types of disparities, and so it does seem to suggest that there is also a role for biology in contributing to the propensity to develop and die from advanced disease among black men with prostate cancer.”

It is because biology is involved that the need for greater numbers of black men in prostate cancer trials is urgent. “Clinical trials and clinical research participation are critical parts of innovation and the development of curative therapeutic options for patients,” explained Borno.

Further, it is sometimes because of the socioeconomic strains on black patients that they are poorly represented in trials. “Cancer clinical trials require frequent appointments. These appointments can be lengthy. It requires a considerable amount of time for patients and for caregivers. And these costs that are placed on patients are difficult to measure and frequently not recouped,” Borno explained.

Improving Access to Care

Borno is principal investigator for a study called the IMPACT study, which is under the umbrella of the IMPACT program (Improving Patient Access to Cancer Clinical Trials) being conducted by the Lazarex Cancer Foundation. IMPACT is a 3-year pilot study with a comprehensive approach to improving patient enrollment, retention, minority participation, and equitable access in oncology trials. UCSF is one of several institutions participating in this study which has been accruing participants since April.

The purpose is to develop a financial reimbursement program to cover the ancillary costs associated with cancer clinical trial participation. “This program will cover the indirect costs like gas, parking, flights, hotels, Ubers/Lyfts/taxis, rental cars, etc., for a patient and a caregiver. These costs can be considerable and cause patients to decline participation in the clinical trial because they simply can't afford to be part of them,” said Borno.

“Another piece that is important to consider is the economic opportunity loss, and that is something that is not measured and certainly not reimbursed,” she added. “If you have patients whose income is based on hourly work, and they're taking time off work to go to these appointments, there is economic opportunity loss. By extension, you can infer that the financial toxicity or the problems associated with cost of care for patients who are wage workers are going to be more severe than for patients who are more affluent. That suggests that there is differential access to clinical trials as a result of socioeconomic status.”

Borno said delving into disparities surrounding cancer patients is not an easy task. “The reality is it's complex; this type of research is really challenging because you are trying to adjust for all the potential factors that could be contributing to observed trends,” she explained.

“There is, however, robust ongoing research to understand the biological differences between different racial ethnic subsets affected with prostate cancer. And when we talk about the biological differences, some of those are a reflection of the cancer itself. But some of the differences also are heritable risks, so we must be looking at germline profiling and hereditary risk of developing an advanced disease, and how that might vary by race ethnicity. All of these things contribute.”

It is noteworthy to mention that there is emerging positive news for men of color with prostate cancer. “There's been some really interesting new data to suggest that African American men actually may have a more robust response to some of our therapeutics in advanced disease. This was reflected in some survival data looking at the PROCEED registry for sipuleucel-T.”

Similarly, preliminary data suggests African American men with metastatic castration-resistant prostate cancer live longer after treatment with the androgen inhibitors abiraterone acetate or enzalutamide than white men.

“That's really hopeful and encouraging; we can see that if we can get diverse patient populations on clinical trials, we can start to understand differential efficacy by racial ethnic subgroups,” said Borno. “That inspires my work. Diverse enrollment in clinical research is important so we can catch these signals, understand the biology that leads to improved response, and address cancer disparities.”

Direction & Perspective

Borno, an avid runner and road biker, is also the happily married mother of two young sons (an infant and a toddler). Originally from North Carolina, her first inkling to study medicine came about when she was 16.

“I observed my mom grapple with the reality that her father was facing a diagnosis of advanced cancer. I felt her fear. I felt her worry,” recalled Borno. “And I recognized that a big part of her fear and worry was related to not understanding the disease. That made me realize that at some point my parents might have to deal with a serious medical diagnosis, too, and I wanted to have more information. I told my mother that I was going to be a physician so that I would never feel the way she felt. I never wavered.”

Subsequently, Borno studied biochemistry at the University of North Carolina (UNC) in Chapel Hill. After graduating with honors, she stayed there as a Loyalty Fund scholar and completed her doctorate at UNC before going to UCSF for her internal medicine residency training and medical oncology fellowship training. She has now joined the UCSF faculty as Assistant Professor in the Division of Hematology/Oncology.

The clinician said she feels honored to interact with patients and families when they feel most vulnerable. “It is quite a privilege to help walk them through that journey, understand what their options are, and access the best care,” Borno said.

She also commented on the understanding that comes with the intensity of her chosen work. “It's only natural to have the practice of oncology influence and permeate other aspects of my life,” she said, pensively. “Dealing with the fragility of life and the uncertainty of life certainly gives one perspective and balance. It gives me a grateful attitude and a recognition of the blessings that I have in my life—my health and my loved ones.”

Valerie Neff Newitt is a contributing writer.

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