Minorities face extra hurdles in cancer trials
While investment in research is getting results, the patients are overwhelmingly white
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 has no doubt that the experimental treatments he received have saved his life.
Jones, 45, has an aggressive type of Hodgkin 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 life-saving advances in immunotherapy. But he’s an outlier: He is African-American.
As money pours into immunotherapy research and promising results multiply, patients getting 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, 92 per cent were white. Three per cent were black, 3 per cent were Asian and 3 per cent were listed as “other.”
In the second study, of 821 people with kidney cancer, 88 per cent were white, 9 per cent Asian and just 1 per cent black.
According to 2015 census figures, whites make up 77 per cent of the United States population, blacks 13.3 per cent and Asians 5.6 per cent.
A1993 law requires that all medical research conducted or paid for by the National Institutes of Health (NIH) include enough minorities and women to determine whether they respond to treatment differently than other groups. Minority enrolment in its studies was about 28 per cent in clinical research and 40 per cent in Phase III clinical trials in 2015, the NIH said.
But the NIH paid for only about 6 per cent of all clinical trials in the U.S. 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, BristolMyers 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 enrol 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 centre. Moreover, minority patients with cancer are more likely to have other, poorly controlled chronic diseases such as 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 enrol, financial 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 in Houston. But many, she said, “would participate if they were asked.”
Trials can offer huge advantages, like new treatments that may otherwise be unavailable. Expensive drugs and tests are often free. The care is often better than routine treatment because patients see doctors more frequently and have more tests.
Though success is not guaranteed, a clinical trial can be a lifeline.
“Clinical trials are the most advanced treatment, the most cuttingedge therapies we have,” said Dina G. Lansey, the assistant director for di- versity and inclusion in clinical research at the Johns Hopkins Kimmel Cancer Center. “They should be available to everybody.”
Clinical trials can reveal things useful to a whole ethnic or racial group. For instance, a drug for kidney cancer, sunitinib, has proved more likely to cause skin problems in Asians than in whites. But how black people compare is not known because not enough have been included in studies, said Dr. Robert J. Motzer, an oncologist at Sloan Kettering.
But Dr. Otis W. Brawley, chief medical officer of the American Cancer Society, said, “When we look at race, it matters sociopolitically far more than biologically.” He said lower enrolment of minorities in clinical trials was part of a larger problem of unequal care that contributes to higher death rates from treatable cancers in some groups.
There were 23 people in the small study that probably saved Jones’ life. He was one of two blacks — a higher proportion than in most larger studies. Jones said that he was unaware of any racial divide in research and that his stubborn personality and determination to live drove him to find studies, entirely on his own.
He was treated for two years. His tumours shrank and he has been off treatment for a year. Doctors aren’t sure whether the cancer is gone or kept at bay by his immune system.
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.’ ”
“One of the biggest barriers is doctors not asking patients to join clinical trials because they assume they would not be trial candidates.” DR. ELISE D. COOK MD ANDERSON CANCER CENTER