Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
Prognostic value of post-neoadjuvant pathological response and residual disease in early breast cancer: a real-world cohort study.
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Ferro Antonella, Campora Michela, Eccher Claudio, Lorenzi Martina, Biondi Roberta, Caldara Alessia, Cantarelli Sara, Campregher Monica, Carbone Giuseppe, De Lisi Delia, Dipasquale Mariachiara, Lazzeri Silvia, Monteverdi Sara, Armatura Giulia, De Rose Fiorenza, Gori Stefania, Valentini Marvi, Caffo Orazio
Аннотация
BACKGROUND: Neoadjuvant chemotherapy (NAC) enables tumor downstaging and assessment of response in early breast cancer (EBC). Pathological complete response (pCR) predicts favorable outcomes, but patients with residual disease are heterogeneous, and the prognostic value of residual tumor biology remains incompletely defined.
METHODS: We retrospectively analyzed 586 patients with EBC treated with NAC between 2000 and 2021. Baseline clinical, pathological, and treatment-related variables-including residual disease characteristics-were collected. The primary endpoints were pCR and long-term outcomes. Event-free survival (EFS), relapse-free survival (RFS), and overall survival (OS) were estimated using Kaplan-Meier curves and compared with log-rank tests. Multivariable logistic and Cox regression identified independent predictors of pCR and survival.
RESULTS: Overall, 36.3% of patients achieved pCR, highest in HER2-positive (48.6%) and triple-negative tumors (45%). HER2-low/negative status, HR positivity, higher T stage, and lower Ki-67 independently reduced the likelihood of pCR. At a median follow-up of 88 months, patients achieving pCR had superior 7-year outcomes (EFS 86.5% vs 71.6%, RFS 91.1% vs 74.7%, OS 94.9% vs 81.7%; all p < 0.001). Among patients with residual disease, higher nodal burden (ypN2), high post-treatment Ki-67 (> 20%), residual HER2 positivity, and residual Hormone receptor (HR) negativity were independent predictors of poorer outcomes. No baseline or residual characteristics independently affected survival in patients achieving pCR.
CONCLUSION: pCR strongly predicts long-term outcomes, particularly in aggressive subtypes. Among patients with residual disease, higher nodal burden (ypN2), high post-treatment Ki-67 (> 20%), residual HR negativity, and residual HER2 positivity were independent predictors of poorer outcomes, supporting biologically informed risk stratification beyond pCR.
METHODS: We retrospectively analyzed 586 patients with EBC treated with NAC between 2000 and 2021. Baseline clinical, pathological, and treatment-related variables-including residual disease characteristics-were collected. The primary endpoints were pCR and long-term outcomes. Event-free survival (EFS), relapse-free survival (RFS), and overall survival (OS) were estimated using Kaplan-Meier curves and compared with log-rank tests. Multivariable logistic and Cox regression identified independent predictors of pCR and survival.
RESULTS: Overall, 36.3% of patients achieved pCR, highest in HER2-positive (48.6%) and triple-negative tumors (45%). HER2-low/negative status, HR positivity, higher T stage, and lower Ki-67 independently reduced the likelihood of pCR. At a median follow-up of 88 months, patients achieving pCR had superior 7-year outcomes (EFS 86.5% vs 71.6%, RFS 91.1% vs 74.7%, OS 94.9% vs 81.7%; all p < 0.001). Among patients with residual disease, higher nodal burden (ypN2), high post-treatment Ki-67 (> 20%), residual HER2 positivity, and residual Hormone receptor (HR) negativity were independent predictors of poorer outcomes. No baseline or residual characteristics independently affected survival in patients achieving pCR.
CONCLUSION: pCR strongly predicts long-term outcomes, particularly in aggressive subtypes. Among patients with residual disease, higher nodal burden (ypN2), high post-treatment Ki-67 (> 20%), residual HR negativity, and residual HER2 positivity were independent predictors of poorer outcomes, supporting biologically informed risk stratification beyond pCR.