Clinical outcomes and immune markers by race in a Phase I/II clinical trial of durvalumab concomitant with neoadjuvant chemotherapy in early stage TNBC
Abstract
Background: The incidence of triple negative breast cancer (TNBC) is higher among Black or African American (AA) women, yet they are underrepresented in clinical trials. To evaluate safety and efficacy of durvalumab concurrent with neoadjuvant chemotherapy for stage I-III TNBC by race, we enrolled additional AA patients to a Phase I/II clinical trial. Methods: Our study population included 67 patients. The primary efficacy endpoint was pathologic complete response (pCR; ypT0/is,N0) rate. Chi-Squared tests were used to evaluate associations between race and baseline characteristics. Cox proportional hazards models were used to assess association between race and overall survival (OS) and event free survival (EFS). Multivariate logistic regression analyses were used to evaluate associations between race and pCR, immune-related adverse events (irAEs) and recurrence. Results: Twenty-one patients (31%) self-identified as AA. No significant associations between race and baseline tumor stage (p=0.40), PD-L1 status (0.92) and stromal tumor infiltrating lymphocyte (sTIL) count (p=0.57) were observed. pCR rates were similar between AA (43%) and non-AA patients (48%) (p=0.71). 3-year EFS were 78.3% and 71.4% in non-AA and AA patients, respectively. (HR 1.451, 95% CI 0.524–4.017; p=0.474); 3-year OS was 87% and 81%, respectively (HR 1.72, 95% CI 0.481–6.136; p=0.405). The incidence of irAEs was similar between AA and non-AA patients and no significant associations were found between…
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