Mitch Hayes, MD, on Uptake of Novel Therapies for Metastatic RCC
– 11-year analysis looked at race-related access and survival
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Many new therapies were approved over the last decade for patients with metastatic clear-cell renal cell carcinoma (mccRCC), but has access to these novel therapies and survival outcomes been equitable by race? Research presented at the explored the question.
Mitch Hayes, MD, and colleagues at H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida, analyzed data on 7,133 patients in the longitudinal treated from 2011 through 2022. The majority (69%) were white, while 7% were Black and approximately 13% were "other non-white."
A total of 31.4% of the patients overall received at least one recently approved therapy during the study period, and access to the therapies did not differ significantly by race (31.8% for whites, 31.5% for Blacks, and 30.5% for other races).
Black race, however, was associated with a 24% higher mortality risk compared with white race (95% CI 1.11-1.39, P=0.0003). The risk was more pronounced in patients under age 65 (95% CI 1.17-1.63, P=0.0001).
"This study assessed real-world access to novel therapies along with racial and social disparities for mccRCC patients and their impact on clinical outcomes," the researchers wrote. "This is the first study in the immunotherapy era to highlight the worse overall survival of Black patients with mccRCC."
Hayes offered additional details and discussed implications in the following interview.
Tell us more about the Flatiron database and how it captures real-world data.
Hayes: Flatiron Health collects longitudinal clinical data from both community and academic medical oncology practices nationwide through a proprietary electronic health record system. Granular oncology-relevant variables are then extracted and curated, which gives researchers access to standard variables that you might find in the cancer registry, but also many other unique data points, such as month-to-month details about specific prescriptions and lab information. This was the foundation for our project, which examined racial disparities in the use of novel therapies for mccRCC. Flatiron data can tell us exactly what prescriptions patients received, when, and for how long.
Were you surprised by the finding that access to novel therapies did not differ by race?
Hayes: We hypothesized that novel therapies would indeed differ by race, but we found, on univariate analysis, that uptake did not differ by race. However, I don't think we can conclude at this point that race does not impact the use of novel therapy. We know that these groups have baseline differences in factors that might affect use of a novel therapy, as well as unmeasured factors.
Thus, we hope to continue this work using a contemporary multivariable mediation approach for additional answers.
If access to novel therapies was the same, what else might be driving the racial disparities in survival outcomes?
Hayes: I think if we found, after adjusting for multiple factors, that the use of novel therapy is not impacting survival disparities, then the remaining causes can be boiled down to some manifestation of racism or, much less likely, a biological cause.
"Race" is a social construct, and self-identified racial groups are not a reliable predictor of some genetic predisposition to having worse clinical outcomes. These questions are extremely different to answer but I am very hopeful that additional research might be able to elucidate the answers.
Did your study find other patient characteristics associated with survival outcomes or access to novel therapies?
Hayes: Yes, interestingly on univariate analysis we found that younger patients and patients treated at a community practice were more likely to be treated with first-line novel therapy. I think that the younger patient effect makes sense, as perhaps younger patients (and their oncologists) are perhaps more motivated to be treated with the "latest and greatest," or perhaps the inverse is that ageism plays a role for older patients.
The practice-setting effect was curious, and we are not sure why this is the case. The patient populations at academic and community practices who are prescribed first-line therapy are distinct, so again, multivariable analysis would be needed to determine if this is more patient-related versus provider-related.
Do you plan additional research in this area?
Hayes: Yes, we are currently preparing to share the results from a multivariable mediation analysis which will take a deeper dive into the impact of novel therapy uptake on the survival disparity we see in mccRCC.
Another observation from this study was the still very low number of patients receiving any second-line therapy (about 66% of patients receiving at least one systemic therapy for mccRCC). This is consistent with historic data; however more research is needed to determine possible causes of this and whether this rate is changing over time.
Read the study here and expert commentary about it here.
The study was sponsored by Flatiron Heath.
Hayes reported no conflicts of interest; several co-authors reported relationships with industry.
Primary Source
Journal of Clinical Oncology
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