Minorities seldom seen in cancer studies
Researchers say other health issues, finances impede their participation
Like a man on a flying trapeze, K.T. Jones has leapt from one medical study to another during his 15-year struggle with cancer, and he has no doubt that the experimental treatments he has received have saved his life.
Jones, 45, has an aggressive type of Hodgkin’s lymphoma that resists the usual therapies. At the start of his most recent clinical trial, his life expectancy was measured in months. That was more than three years ago. He received a drug that helped his immune system fight cancer — a type of immunotherapy, the hottest area in cancer research and treatment.
“I’ve been over 12 months now with no treatment at all,” he said. “I walk half-marathons.”
Jones is one of many patients who have benefited from lifesaving advances in immunotherapy. But he’s an outlier: He is African-American. As money pours into immunotherapy research and promising results multiply, patients getting the new treatments in studies have been overwhelmingly white. Minority participation in most clinical trials is low, often out of proportion with the groups’ numbers in the general population and their cancer rates. Many researchers acknowledge the imbalance, and say they are trying to correct it.
Two major studies of immunotherapy last year starkly illustrate the problem. The drug being tested was nivolumab, a type of checkpoint inhibitor, one of the most promising drug classes for cancer. In both studies, patients taking it lived significantly longer than those given chemotherapy.
In the first study, of 582 patients with lung cancer, about 92 percent were white. Three percent were black, 3 percent were Asian and 3 percent were listed as “other.” In the second study, of 821 people with kidney cancer, 88 percent were white, 9 percent Asian and just 1 percent black. Less aware of research
A 1993 law requires that all medical research conducted or paid for by the National Institutes of Health include enough minorities and women to determine whether they respond to treatment differently than other groups. Minority enrollment in its studies was about 28 percent in clinical research and 40 percent in Phase III clinical trials in 2015, the NIH said.
But the NIH paid for only about 6 percent of all clinical trials in the United States in 2014, and those it does not support do not have to adhere to its rules. The lung and kidney studies of nivolumab, for instance, were paid for by the drug’s maker, Bristol-Myers Squibb.
Researchers say such studies, geared toward getting a drug approved for new uses, are often done quickly, and minority patients may be left out because it can take longer to find and enroll them.
One obstacle, researchers say, is that people in minority groups tend to have lower incomes and less education, and therefore less awareness of medical studies and how to find them. Many live in areas that do not have easy access to a major cancer center. Moreover, minority patients with cancer are more likely to have other, poorly controlled chronic diseases like diabetes that may make them ineligible for studies, according to Dr. Julie R. Brahmer, from the Johns Hopkins Kimmel Cancer Center.
Even if they do qualify and want to enroll, finan- cial hurdles can be daunting. Studies may involve frequent trips to the hospital, requiring time off work and expenses for travel, parking and child care. Some doctors simply assume that lower-income, minority patients could not manage it.
“One of the biggest barriers is doctors not asking patients to join clinical trials because they assume they would not be trial candidates,” said Dr. Elise D. Cook, from the MD Anderson Cancer Center. But many, she said, “would participate if they were asked.”
One way to increase minority enrollment that some researchers favor is conducting studies that focus on specific racial or ethnic groups. Another solution, some suggest, would be for medical jour- nals to refuse to publish studies unless they include appropriate numbers of women and minorities. ‘Have to self-advocate’
The small study that probably saved Jones’ life had 23 people. He was one of two blacks — a higher proportion than in most larger studies.
Jones said that his stubborn personality and determination to live drove him to find studies, entirely on his own.
“I made a commitment to a lifetime with my wife,” he said. “A lifetime wasn’t going to be a year or two.”
He scoured ClinicalTrials.gov, which lists available studies for many diseases. A drug name he saw led him to an online video describing a study at MD Anderson for patients like him.
Jones lives in Delaware and thought MD stood for Maryland, a short drive away. He was stunned to find out the hospital was in Houston. He and his wife had to stop paying their mortgage to afford plane tickets. Eventually, they lost their house. But the treatment worked — for a while.
When he relapsed, he could not afford to keep traveling to MD Anderson. His doctor there helped him transfer his care to Sloan Kettering in New York. Again, experimental treatments helped, but temporarily.
Then he hit the jackpot. In 2013, he entered a trial of the checkpoint inhibitor nivolumab. He was treated for two years. The study became a landmark, with an 87 percent response rate among patients like Jones, who had burned through every other option.
“This was just hitting it out of the park,” said Dr. Alexander M. Lesokhin, his oncologist at Sloan Kettering.
Jones was treated for two years. His tumors shrank, and he has been off treatment for a year. Doctors are not sure whether the cancer is gone or being kept at bay by his immune system. But he is feeling well and has embarked on a new career that he loves, photographing jazz musicians.
As for his illness, he said: “I didn’t have a specific person to guide me. Everything fell into place for me because I pushed for it. I’m telling everyone else: ‘Don’t give up. You have to self-advocate.’”