A Real-World Efficacy and Safety of KEYNOTE-522 Regimen in Patients With Early Triple-Negative Breast Cancer

This is the authors' abstract. We don't add key points for this paper.

PURPOSE: Based on the KEYNOTE-522 study, neoadjuvant pembrolizumab plus chemotherapy has become the standard treatment for early-stage triple-negative breast cancer (TNBC). This study evaluated the real-world efficacy, safety, and predictors of pathologic complete response (pCR) in Korean patients. METHODS: We conducted a retrospective cohort study of 174 patients with early-stage TNBC who received the KEYNOTE-522 regimen (neoadjuvant pembrolizumab plus paclitaxel and carboplatin, followed by doxorubicin and cyclophosphamide) at a tertiary cancer center between August 2022 and July 2024. We assessed the primary endpoints, including pCR rate and event-free survival (EFS). We performed univariable and multivariable logistic regression analyses to identify independent predictors of pCR. RESULTS: = 0.007). The treatment completion rate was 92.0%, and immune-related adverse events occurred in 13.8% of patients. CONCLUSION: In this real-world analysis of one of the largest Asian cohorts of patients with early-stage TNBC treated with neoadjuvant pembrolizumab, the KEYNOTE-522 regimen demonstrated substantial efficacy and manageable toxicity, consistent with the original trial findings.