TY - JOUR
T1 - Clinical Outcomes and Immune Markers by Race in a Phase I/II Clinical Trial of Durvalumab Concomitant with Neoadjuvant Chemotherapy in Early-Stage TNBC
AU - Foldi, Julia
AU - Kahn, Adriana
AU - Silber, Andrea
AU - Qing, Tao
AU - Reisenbichler, Emily
AU - Fischbach, Neal
AU - Persico, Justin
AU - Adelson, Kerin
AU - Katoch, Anamika
AU - Chagpar, Anees
AU - Park, Tristen
AU - Blanchard, Adam
AU - Blenman, Kim
AU - Rimm, David L.
AU - Pusztai, Lajos
N1 - Publisher Copyright:
© 2022 American Association for Cancer Research.
PY - 2022/9/1
Y1 - 2022/9/1
N2 - Purpose: 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. Patients and Methods: Our study population included 67 patients. The primary efficacy endpoint was pathologic complete response (pCR; ypT0/is, N0) rate. x2 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 (irAE) and recurrence. Results: Twenty-one patients (31%) self-identified as AA. No significant associations between race and baseline tumor stage (P ¼ 0.40), PD-L1 status (0.92), and stromal tumor–infiltrating lymphocyte (sTIL) count (P ¼ 0.57) were observed. pCR rates were similar between AA (43%) and non-AA patients (48%; P ¼ 0.71). Three-year EFS rates were 78.3% and 71.4% in non-AA and AA patients, respectively [HR, 1.451; 95% confidence interval (CI), 0.524–4.017; P ¼ 0.474]; 3-year OS was 87% and 81%, respectively (HR, 1.72; 95% CI, 0.481–6.136; P ¼ 0.405). The incidence of irAEs was similar between AA and non-AA patients and no significant associations were found between irAEs and pathologic response. Conclusions: pCR rates, 3-year OS and EFS after neoadjuvant immunotherapy and chemotherapy were similar in AA and non-AA patients. Toxicities, including the frequency of irAEs, were also similar.
AB - Purpose: 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. Patients and Methods: Our study population included 67 patients. The primary efficacy endpoint was pathologic complete response (pCR; ypT0/is, N0) rate. x2 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 (irAE) and recurrence. Results: Twenty-one patients (31%) self-identified as AA. No significant associations between race and baseline tumor stage (P ¼ 0.40), PD-L1 status (0.92), and stromal tumor–infiltrating lymphocyte (sTIL) count (P ¼ 0.57) were observed. pCR rates were similar between AA (43%) and non-AA patients (48%; P ¼ 0.71). Three-year EFS rates were 78.3% and 71.4% in non-AA and AA patients, respectively [HR, 1.451; 95% confidence interval (CI), 0.524–4.017; P ¼ 0.474]; 3-year OS was 87% and 81%, respectively (HR, 1.72; 95% CI, 0.481–6.136; P ¼ 0.405). The incidence of irAEs was similar between AA and non-AA patients and no significant associations were found between irAEs and pathologic response. Conclusions: pCR rates, 3-year OS and EFS after neoadjuvant immunotherapy and chemotherapy were similar in AA and non-AA patients. Toxicities, including the frequency of irAEs, were also similar.
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U2 - 10.1158/1078-0432.CCR-22-0862
DO - 10.1158/1078-0432.CCR-22-0862
M3 - Article
C2 - 35903931
AN - SCOPUS:85137138606
SN - 1078-0432
VL - 28
SP - 3720
EP - 3728
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 17
ER -