Abstract IA26: Learning from and Addressing Racial and Ethnic Disparities in Cancer Clinical Trials: The ECOG-ACRIN Experience

Abstract

Abstract Although breast cancer incidence and mortality have declined by about 35% in the United States since 1990, mortality rates have declined less in Black women, contributing to a widening of the racial gap which has contributed to about a 35% higher mortality rate for Black women compared with others. Black women are more likely to present with advanced stage disease, have triple negative breast cancer (TNBC), exhibit greater non-adherence and poorer tolerance to chemotherapy and endocrine therapy, and have more comorbidities and experience more disparities in care. With regard to ethnicity, Hispanic women also exhibit higher rates of TNBC, but otherwise experience similar outcomes as non-Hispanic women. In order to disentangle factors that may be contributing to inferior outcome associated with Black race, we evaluated the association between Black race or Hispanic ethnicity and recurrence in the population served by Montefiore Medical Center and in 3 clinical trials (E1199, E5103, TAILORx) coordinated by the ECOG-ACRIN Cancer Research Group, as summarized in Table 1. The results were remarkably consistent – Black race was associated with significantly higher recurrence risk (1.39-1.84-fold) in multivariate models in ER+ breast cancer, but not ER-negative breast cancer. Similar findings were not observed for Hispanic women. In the TAILORx trial, there were no significant differences in distribution of 21-gene recurrence score, nor ER, PR, or HER2 RNA expression levels, by race or ethnicity. In other analysis, we have reported specific genetic variants associated with higher risk of taxane-induced neuropathy in Black women (PMID: 26138065). Our findings highlight the need for greater representation of racial and ethnic minorities in clinical trials, and that additional studies designed specifically to determine if socioeconomic factors, biological factors, and/or other factors contribute to these disparities. ECOG-ACRIN is currently conducting a clinical trial to prospectively validate genetic variants associated with higher risk of peripheral neuropathy in Black women with breast cancer receiving taxane therapy (EAZ171; NCT04001829). Citation Format: Joseph A. Sparano. Learning from and Addressing Racial and Ethnic Disparities in Cancer Clinical Trials: The ECOG-ACRIN Experience [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr IA26.