Addressing Cancer Disparities Promotes Precision Medicine for All

Here’s a staggering fact: African Americans have the highest overall risk of developing cancer compared to other racial or ethnic groups, yet they represent just a tiny fraction of participants in clinical trials evaluating the latest advancements in cancer treatments. That means researchers need to promote racial equity in clinical trials.

Many exciting discoveries occur because patients are willing to participate in clinical trials, where the safety and efficacy of new therapies are strictly evaluated. With the exciting promise of precision medicine, where the goal is a more customized approach to each cancer patient, participation in clinical trials by representative samples of all ethnic and racial groups is more important than ever.

“Overall, African Americans have higher incidence and mortality rates for many cancers,” said Washington University radiation oncologist Lannis Hall, MD, MPH, who treats patients at Siteman Cancer Center, which is based at Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis. “As we advance precision medicine and individualize treatments, which are often based on an individual’s specific cancer footprint, we need to ensure that treatment guidelines and recommendations benefit everyone.”

A study in the Journal of the American Medical Association published in 2021 found that in clinical trials specifically focused on the latest precision cancer treatments for breast, lung, prostate and colorectal cancers, only about 10% of study participants were African American.

“Clinical trials are critical in every phase of cancer, from screening and diagnosis to treatment,” Hall said. “Clinical trials determine when a person should be screened for cancer and how often, as well as the safety and effectiveness of most every treatment offered. We must ensure that our guidelines and recommendations are effective for all.”

To do that, there is a concerted effort to eliminate disparities in treatment outcomes by directly addressing racial equity in clinical trials. Researchers already know that socioeconomic factors such as transportation to and from a clinical trial site and access to doctors are significant barriers to broadening diversity. Generational mistrust of the health-care system also is to blame.

“We can’t sweep past abuses in the name of research under the rug,” Hall said. “The Tuskegee syphilis experiment, in which African Americans were not given treatment so that disease progression could be simply observed for more than 40 years, is still cited by many as a reason to distrust the health-care system. However, many protections are now in place for participants. We are simply doing ourselves a great disservice if we don’t advocate for more minority participation in clinical trials.”

Hall says the way to combat hesitation in clinical trial participation is to note the checks and balances governing all clinical trials today. They include:

• Informed Consent. Every potential participant in a clinical must receive information about the drug or device being tested, as well as the opportunity to ask questions and take time to consider enrolling. He or she will receive a description of all procedures in the clinical trial and learn about potential benefits, risks or side effects, how the trial will work and how long they will be part of a study.

 

• Institutional Review Board. Every clinical trial must be approved by an Institutional Review Board (IRB), which ensures that appropriate steps are taken to protect the rights and welfare of patients enrolled in clinical trials. IRBs include not only health-care professionals but also community representatives.

 

• Voluntary Participation. The decision to be part of a study is completely voluntary. A patient can decline to participate or withdraw at any time.

Charles Anglin, PhD, is a strong advocate for participating in clinical trials to advance medical treatments for all. Anglin, a retired biochemist and former research scientist at biopharmaceutical company Pfizer, has spent a lifetime collecting and analyzing data and studying the effectiveness of multiple drugs, many of which found their way into the prescription drug realm for the treatment of arthritis, high blood pressure or other conditions.

“I have seen the benefit of drug development and clinical trials, and now I’m helping to advance medicine in a more personal way,” he said.

Anglin is participating in a phase 2 clinical drug study at Siteman Cancer Center. Results of the study could advance the standard of care for the treatment of moderately aggressive prostate cancer.

“It’s a chance for me to participate in a study that compares the current treatments available with a potentially better treatment,” he said. “It’s also a chance for me to make a difference not only for prostate cancer treatments in general but for African Americans as well.”

African American men have a higher risk of developing prostate cancer than other racial or ethnic groups. While 1 in 8 American men overall will be diagnosed with prostate cancer in his lifetime, the statistic rises to 1 in 6 for African American men. The American Cancer Society also notes that Black men also are diagnosed at younger ages and are more likely to die from prostate cancer than white men. Why? Researchers are trying to find the root cause, but it’s likely a combination of socioeconomic factors and genetic makeup.

Treating cancer, then, goes beyond the type of cancer and its location and severity. Gender, age and race can alter a person’s response to a specific treatment. In the case of race, a lack of participation by African Americans in clinical trials can mean that the latest screening guidelines and treatment options may not be as effective as initially determined.

Equity in Cancer Screening Guidelines

An example can be seen in the screening guideline for prostate cancer, which is recommended for the general population beginning at age 55 when someone doesn’t have a family history of the disease. But with Black men more likely to develop prostate cancer at younger ages, studies have found that the screening recommendation for Black men should be at least a decade earlier, between ages 40-45, with annual screenings continuing until age 70.

Anglin’s cancer was caught during an annual screening. He had a simple prostate-specific antigen (PSA) blood test annually for years. “It was always low, around a 3.4 or so,” he says. “But late last year, the PSA test came back at 14, and it shocked me because I had no other symptoms.”

During a follow-up visit one month later, a urologist found that Anglin’s PSA level had continued to rise rapidly. He was soon diagnosed with a moderately aggressive form of prostate cancer.

A New Treatment Option

At the time of Anglin’s diagnosis, a new drug, darolutamide (Nubeqa®) was moving through clinical trials. In 2022, studies found that men with hormone-sensitive prostate cancer that had spread to other parts of the body had lower mortality rates when radiation therapy was paired with darolutamide and two other drugs that blocked the production of male sex hormones that fueled the cancer.

Phase 2 clinical trials now are underway. This time, studies are focused on whether the drug combination is effective in treating moderately aggressive prostate cancer that has not spread outside of the prostate gland. Anglin enrolled in the study to see if the newest drug therapies could help him and others.

“I can participate in the trial mainly from my home,” he said. “I take four pills a day, two in the morning and two at night, for 28 days, and then I come into the hospital for blood work. I then get another round of medication and repeat the cycle. I started last year in May and ended in October. So now, they are checking to see how well the drugs did against my cancer.”

Hall said clinical trials offer access to some of the best, most-effective treatments. That’s why she recommends that patients seek treatment at health-care institutions that offer numerous clinical trials.

“They compare the latest advancements with standard-of-care treatment options to see if we can keep improving outcomes,” she said. “It’s like making sure we vote in elections. We need to participate in the process and advocate for ourselves. Don’t sit on the sidelines. Especially as medicine moves toward these precise, customized cellular and immunotherapy treatment options, we need to make sure we are a part of advancing medicine for all.”

 

 

This post was originally published in The St. Louis American.