1. DiGiulio, Sarah

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"After 3 decades of interventions in racial/ethnic health care disparity outcomes, statistics continue to show overall death rate disparities between black and white patients for virtually all cancer types," coauthors Abiola Ibraheem, MD, a third-year oncology fellow, and Blase Polite, MD, Associate Professor of Medicine, both at the University of Chicago Medicine, write in a recent editorial (Cancer 2017;123(24):4752-4756).

Abiola Ibraheem, MD.... - Click to enlarge in new windowAbiola Ibraheem, MD. Abiola Ibraheem, MD

The disparity does not end there. Black patients are also more likely to be diagnosed with cancers at later stages than white patients. Black patients are more likely to die of their cancers than white patients. And though patients with cancer who are Hispanic, Asian, and Pacific Islander have lower rates of incidence of cancer and suffer fewer deaths compared with patients who are white, they are more likely to be diagnosed at a later stage.


That's all according to the latest cancer incidence data available, including from the Cancer Statistics 2017 report from the American Cancer Society (CA Cancer J Clin 2017;67:7-30).


One major problem, which Ibraheem and Polite focus on in their editorial, is that black patients and other minorities are underrepresented in cancer clinical trials. One study from the FDA that the coauthors cite in their editorial found that, for new anticancer drugs approved between 2011 and 2016, blacks represented only 5 percent of participants in clinical trials supporting those approvals.


The solution to this problem needs to focus on multiple strategies aimed at multiple levels of the issue: solutions that focus on the patient, provider, and trial design, according to Ibraheem and Polite. They say such solutions might include the following:


* better health education tools about cancer clinical trials for patients;


* using patient navigation to improve delivery of clinical trial education;


* improving quality of communication between patients and providers to reduce and prevent potential mistrust (which means better and more education for providers about diversity);


* billing codes (from the federal government through the Medicare program) that clinicians can use to get reimbursed for the additional time required for discussion, consent, and getting patients enrolled in clinical trials;


* better evaluating patients for eligibility in clinical trials (and not excluding minority patients who may have comorbidities that don't threaten the scientific integrity of that protocol); and


* recruitment targets for racial and ethnic minority patients for new drugs seeking FDA approval (which would create incentives for pharmaceutical companies to also get involved and help pay for other individual action items that would push the needle on this issue and improve minority clinical trial participation).



In an interview with Oncology Times, Ibraheem elaborated on this issue and why addressing it now is critical.


1 Why is this issue such an important one to talk about and better to address now?

"The death rate disparity between African-American and white patients continues to persist despite interventions. [And] cancer therapies are more personalized on a molecular and genetic level, and as such it is now paramount to have minority patients well-represented in clinical trials.


"In recent times, especially in pharma-directed clinical trials, patients with African ancestry have been woefully represented. We may not be clear about the response or toxicity of our new therapies to these patients since they have been sparsely involved in trials. This, in addition to other factors, may begin to widen the disparity gap we have worked so hard to improve on. As such, it is important to address this problem sooner than later."


2 What will help solve this problem and what are the most interesting ongoing efforts now in the works?

"Before the FDA approves therapies, there should be a certain percentage of represented minorities relative to the incidence for that cancer subtype.


"Multiple policies were put into place-such as the NIH Revitalization Act 1993 and the FDA Modernization Act of 1997-that encouraged the representation of minority groups in clinical trials, thereby enhancing heterogeneity of trial populations. An important initiative, The Minority-Based Community Clinical Oncology Program, was created by the NIH in September 1990 to expand the NCI's clinical trials network to minority populations with a major goal of reducing racial disparities in cancer incidence, treatment, survival, and mortality rates.


"These aforementioned initiatives were better functioning when clinical trials were conducted by cooperative groups. Now we have seen a shift to trials being conducted by pharmaceutical industries in multiple sites and emphasis is not laid on enrolling minority patients."


3 What is the bottom line that practicing oncologists and cancer care providers should know about this problem and what they can do to help address it?

We need to pay attention to the clinical trials [for the drugs and therapies they're using] and interpreting them in the context of our minority patients.


"For providers who write clinical trial protocols or place patients on clinical trials, we need to make an effort in actively recruiting minority patients on study."