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Introduction. Triple-negative breast cancer (TNBC) is characterized by an aggressive clinical course and limited systemic treatment options. Platinum-based neoadjuvant chemotherapy (NACT) increases the rate of pathological complete response (pCR), a key surrogate prognostic marker in this population. However, clinicopathological predictors associated with achieving pCR to platinum-based NACT remain insufficiently studied.
Aim. To evaluate the pCR rate and identify clinicopathological predictors of response to platinum-based NACT in patients with TNBC.
Materials and Methods. According to clinical guidelines the study included 260 patients with stage IC–IIIB TNBC who received platinum-based NACT at the P.A. Hertsen Moscow Oncology Research Institute from 2020 to August 2025. Factors associated with pCR were analyzed using non-parametric tests, logistic regression, and survival analysis (Kaplan-Meier, Cox regression). Receiver operating characteristic (ROC) analysis was used to assess the predictive value of continuous variables.
Results. A pCR was achieved in 54.6% of patients. In univariate analysis, pCR was more frequent in patients with BRCA1/2 gene mutations, a high Ki-67 index, and increased tumor-infiltrating lymphocytes (TILs). In multivariate analysis, BRCA1/2 mutation status (OR = 0.113; p = 0.0001) and high Ki-67 (OR = 1.032; p = 0.042) remained independent predictors of pCR. At a median follow-up of 18.5 months, achieving pCR was associated with improved event-free survival (HR = 0.29; p < 0.007). Median TIL levels were significantly higher in patients with pCR, but TILs did not retain independent prognostic significance in the multivariate model.
Conclusion. BRCA1/2 gene mutations and a high Ki-67 index are independent predictors of pCR to platinum-based NACT in patients with early TNBC. TIL levels show limited prognostic value and requires validation in larger cohorts. These findings may aid in personalizing treatment strategies and optimizing patient selection for platinum-based therapy.
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