Black women are twice as likely to be diagnosed with triple-negative breast cancer compared with White women, 28% more likely to die from the disease than White women, and are less likely to be treated with surgery and chemotherapy, according to a study published in 2021. Despite these statistics, Black women with triple-negative breast cancer are underrepresented in clinical trials, especially trials evaluating novel immunotherapy agents.
To better understand the efficacy of combination durvalumab and neoadjuvant chemotherapy in patients with stage I to III triple-negative breast cancer by race, investigators recruited additional Black patients into a phase I/II clinical trial. They found that clinical outcomes were similar between Black patients and patients of other races. Toxicities, including the frequency of immune-related adverse events were also similar. The study, by Foldi et al, is published in Clinical Cancer Research.
Study Methodology
The researchers enrolled 67 patients into the study, 21 (31%) of whom identified as Black, bringing the proportion of Black patients closer to that of the local community. Forty patients identified as non-Hispanic White, three as Hispanic/Latino, and three as Asian. Patient characteristics and baseline tumor features did not differ significantly by race.
The primary endpoint was pathologic complete response (ypT0/is, N0) rate. Chi-squared (C2) tests were used to evaluate associations between race and baseline characteristics. Cox proportional hazard models were used to assess associations between race and overall survival and event-free survival. Multivariate logistic regression analyses were used to evaluate associations between race and pathologic complete response, immune-related adverse events, and recurrence.
Results
The researchers found no significant associations between race and baseline tumor stage, PD-L1 status, or stromal tumor-infiltrating lymphocyte count. Pathologic complete response rates were similar between Black (43%) and non-Black patients (48%; P = .71). Three-year event-free survival rates were 78.3% and 71.4% in non-Black and Black patients, respectively (hazard ratio [HR] = 1.451, 95% confidence interval [CI] = 0.524–4.017; P = .474); 3-year overall survival was 87% and 81%, respectively (HR= 1.72, 95% CI = 0.481–6.136; P = .405).
KEY POINTS
- Black and non-Black patients with triple-negative breast cancer who received combination neoadjuvant durvalumab and chemotherapy experienced similar clinical outcomes.
- Toxicities, including the frequency of immune-related adverse events, were also similar.
The incidence of immune-related adverse events was similar between Black and non-Black patients. No significant associations were found between immune-related adverse events and pathologic response.
“These results suggest that clinical outcomes are similar regardless of race when patients receive identical treatment and follow-up in a highly structured study environment,” the study authors concluded.
Clinical Significance
“Our study demonstrates that if patients are given similar treatment and similar follow-up, the differences in outcome between Black and non-Black patients are reduced,” said Lajos Pusztal, MD, DPhil, Professor of Medicine; Co-Leader, Genetics, Genomics, and Epigenetics; and Scientific Co-Director of the Center for Breast Cancer at Yale School of Medicine, and principal investigator of this study, in a statement. “By improving health-care access and delivery, we could mitigate some of the health-care disparities that exist in our society.”
Dr. Pusztal, of Yale Cancer Center, Yale School of Medicine, is the corresponding author of this study.
Disclosure: Funding for this study was provided by AstraZeneca, a Komen Leadership Grant, and the National Cancer Institute. For full disclosures of the study authors, visit https://aacrjournals.org/clincancerres.
