Interventions overcome endometrial cancer clinical trial inequity in Deep South
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Interventions designed to improve care for Black women with endometrial cancer can help overcome clinical trial inequities, according to findings presented at the virtual Society of Gynecologic Oncology Annual Meeting on Women’s Cancer.
“[In addition], our data show disparate progression-free survival is no longer present between races when patients are enrolled in clinical trials,” Nathaniel L. Jones, MD, assistant professor at University of South Alabama Mitchell Cancer Institute, said during a presentation.
The cancer burden varies widely based on region of the country, with the southern United States assuming an unequal burden of cancer mortality, Jones said. Alabama ranks eighth highest of all states with regard to cancer mortality, he added.
“The burden of cancer also is not shared equitably among racial and ethnic groups,” Jones said.
“The Deep South is home to the vast majority of Blacks and African Americans, who account for 50% of the population across a wide range of southern states. Given the unequal burden of cancer in this region, it is no surprise that Black women in the Deep South have disparate outcomes for gynecologic malignancies compared with white women.”
Black women account for 7% of endometrial cancer diagnoses across the country but 15% of all deaths, Jones said. In addition, Black women are up to 80% more likely than white women to die of their disease.
Equity in gynecologic oncology care has been hindered by underrepresentation of certain racial groups on clinical trials. Previous work from Jones’ institution showed enrollment of Black patients onto national Gynecologic Oncology Group (GOG) trials was 9.8-fold less than that of white patients.
“These data also suggest that enrollment has worsened over time,” Jones said. “Prior to 2000, more than 20% of GOG trial participants were Black, compared with just 6% by 2013.”
Enrollment rates for immunotherapy trials have been even lower, Jones said.
“The onus is on us as providers to provide an approach to cancer care that allows our patients to trust us and provide equitable cancer care for the women we serve,” he said.
To that end, Jones and colleagues implemented patient-based programs designed to increase enrollment of Black patients onto clinical trials at their institution, and then assessed the impact of those interventions on trial enrollment and of race on survival.
They established a lay navigation program at their cancer center in conjunction with oncology care models that focused on improving quality of care by helping to educate patients about the benefits and risks of clinical trials. They also hired a diverse lay navigation workforce that reflected the demographics of the catchment area.
“Given our minority population is over two times the national average, we intentionally hired Black women to act as our patient navigators,” Jones said.
Jones and colleagues then conducted a retrospective cohort study of all women with endometrial cancer diagnosed and treated at their institution between 2012 and 2018.
Investigators used CDC age-adjusted endometrial cancer incidence for race data to calculate expected and observed white-to-Black ratios of racial participation in clinical trials.
The study included 1,021 women with endometrial cancer who had adequate follow-up. Each woman was assigned a lay navigator, and the clinical trial education module was required for all patients.
Eighty-four women enrolled in clinical trials during the study period. This cohort included 23 of 277 Black women (8.3%), as well as 61 of 718 white women (8.5%). The groups were similar with regard to age (mean, 62.1 years for Black vs. 62 years for white) and BMI (37.1 kg/m2 vs. 34.8 kg/m2).
In the entire cohort, Black women had more aggressive histology (P < .01), more advanced-stage disease (P < .01), and were more likely to have Medicaid or self-pay status (P < .01). However, when researchers limited analyses to women who enrolled in clinical trials, they reported no significant differences with regard to stage, grade, histology, insurance status or performance status.
When researchers accounted for age-adjusted endometrial cancer incidence in the United States (27.2 per 100,000 for white vs. 27.5 per 100,000 for Black), they reported the observed enrollment of Black women was similar to the expected enrollment (1.03-fold lower than expected but no statistically significant difference). When researchers used incidence data specific to the Deep South (21.8 per 100,000 for white vs. 24.7 per 100,000 for Black), the observed enrollment for Black patients was 1.15 times higher than expected, once again not reaching statistical significance.
In the entire cohort of women with endometrial cancer, researchers observed a PFS advantage for white women compared with Black women (median, 20 months vs. 14 months; P = .02). However, when they stratified by clinical trial enrollment, they reported no statistically significant difference in PFS between white women and Black women (14 months vs. 13 months).
Perspective
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Kemi M. Doll, MD, MCSR
Our status quo as a field is that we systematically enroll less Black women on cooperative group gynecologic oncology trials, with a 10-fold lower enrollment of Black patients than would be appropriate for the population — a statistic that has worsened over time.
In a high-resource setting with universal clinical trial education of all patients, a lay navigation program with diverse staff targeted toward Black women was initiated. Jones and colleagues reported an equivalent percentage of Black and white women enrolling onto trials and no difference in PFS by race for those enrolled onto trials.
Is this good enough?
I commend the authors greatly for this incredible intervention-focused work. When we are looking at trial enrollment percentages, we must also ask: What was the enrollment percentage by trial eligibility? That is a clearer assessment of true equity.
Second, we know from health disparities theory of fundamental causes that the poorer the prognosis is for a condition, the narrower the racial disparity will be. Therefore, analyses to understand what drove this narrow gap — longer PFS for Black patients enrolled on trials vs. Black patients who were not, or shorter PFS for white patients enrolled on trials vs. those who were not — can help to identify next steps.
I want to encourage and remind everybody to recognize at the local level everyone can do this. A powerful mantra I was exposed to several years ago regarding equity is “Here. Now. Small. Doable.” We are often paralyzed by the longstanding and deeply embedded inequities in our health care system, but we can choose to move into action by following [this mantra]. It reminds us to start with where we are in our immediate work environment; to start now and stop waiting for convenience, because equity work is not convenient; to resist the urgency of a magical solution and instead choose something small, because inequity arises from the overlap of many small, consistent, biased, unjust processes; and finally to remember our own power, focusing on what we can change and not what we can’t.
On the national level, we have tools, not just to assess and study barriers, but facilitators of enrollment of historically excluded populations onto clinical trials. The U.S. Cancer Centers of Excellence Strategies has a report on strategies to increase inclusion of racial and ethnic minorities in clinical trials. Baking these into trial design and recruitment is a known, evidenced-based method to improve enrollment of these populations. Deciding to make these design elements mandatory for trials to be approved and executed is the kind of paradigm-shifting action that is available to us now.
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Jones NL, et al. Abstract 10966. Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (virtual meeting); March 19-25, 2021.
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