A Retrospective Review of Minority Enrollment and Clinical Outcomes in Breast Cancer Clinical Trials at Emory University 公开
Ekpo, Princess (Spring 2020)
Published
Abstract
Background: Black women are 40% more likely to die of breast cancer compared to White women. Inadequate representation of Blacks in clinical trials may contribute to health care inequity. Emory’s Winship Cancer Institute (WCI) in Atlanta services a significant Black population and has a unique opportunity to engage these underrepresented patients in clinical trials. We aimed to assess clinical outcomes in Black versus White women with breast cancer enrolled on investigator-initiated clinical trials (IITs) at Emory.
Methods: Black and White women with breast cancer enrolled on IITs conducted at WCI between 1/2009 and 1/2019 were retrospectively evaluated. Descriptive statistics were generated for all patient characteristics. Univariate analyses and multiple logistic regression models were used to assess the effect of age and race on clinical response, length of time on trial, number of therapy lines prior to trial enrollment, and toxicity on trial. Overall survival patients with metastatic breast cancer (MBC) was assessed using Kaplan Meier analysis.
Results: One hundred and thirty-five women with breast cancer were included [White, n=92 (68.1%), and Black, n=43 (31.9%)]. There were 73 (54.1%) early-stage patients (stages I-III) and 62 patients with MBC. Mean BMI was higher for Black women in comparison to White women for both and early- and late-stage patients (p<0.001 and 0.044, respectively). Black women with MBC were enrolled on trial for less time than White women (5.62 months vs. 7.77 months, respectively, p=0.22) and more likely to have progressive disease (PD) on trial (45% in Blacks vs. 20% in Whites, p=0.05). There were no differences in toxicity rates and overall survival among patients enrolled on IITs based on race.
Conclusions: Black and White women with early-stage breast cancer have no significant difference in clinical outcomes. Black women with MBC who enrolled on IIT trials at Emory had worse treatment response and a trend towards poorer survival compared to White women. More research is needed to determine whether this is due to adverse biology. These results reinforce the need for exploration of biomarkers of response by race and ethnicity and improved representation of minorities in clinical trials to inform real-world efficacy.
Table of Contents
Table of Contents
Abstract......................................................................................................................... 4
Background............................................................................................................... 8-9
Materials and Methods................................................................................................ 9
Patient Population...................................................................................................... 9
Statistical Analyses.................................................................................................... 9
Clinical Outcomes...................................................................................................... 9
Results.................................................................................................................... 10-12
Entire cohort............................................................................................................. 10
Early-stage patients.................................................................................................. 10
Late-stage patients.............................................................................................. 11-12
Discussion.............................................................................................................. 12-14
Table Legends............................................................................................................. 15
Figure Legends........................................................................................................... 16
References............................................................................................................. 17-20
Tables..................................................................................................................... 21-74
Entire cohort........................................................................................................ 21-25
Early-stage patients............................................................................................. 26-46
Late-stage patients.............................................................................................. 47-68
Figures................................................................................................................... 69-70
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