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<p>Pathological complete response (pCR) is an established surrogate endpoint in aggressive breast cancer subtypes; however, its prognostic role in hormone receptor (HR)-positive/HER2-negative disease remains controversial. We aimed to evaluate clinicopathological predictors of pCR and to investigate the prognostic impact of pCR on event-free survival (EFS) and overall survival (OS) in HR-positive/HER2-negative breast cancer treated with neoadjuvant chemotherapy (NAC). This multicenter retrospective cohort study included 379 patients with HR-positive/HER2-negative breast cancer treated with NAC between 2010 and 2025. ER and PR expression levels, Ki-67 index, and histopathological features were analyzed. Factors associated with pCR were evaluated using Firth penalized logistic regression. Survival outcomes were assessed using Kaplan–Meier analysis and Cox proportional hazards models. pCR was achieved in 18.7% of patients. Lower ER expression (≤ 10%) and higher Ki-67 (≥ 20%) were independently associated with increased likelihood of achieving pCR. In multivariate analysis, ER expression &gt; 10% was associated with significantly lower odds of pCR, whereas Ki-67 ≥ 20% independently increased the probability of pCR. Achieving pCR was independently associated with improved EFS (HR range, 0.13–0.17 across models). Younger age and high Ki-67 were also independently associated with worse EFS, while lymphovascular invasion (LVI) retained prognostic significance in one multivariable model. In contrast, pCR was not independently associated with OS. Higher ER expression was consistently associated with improved OS, while advanced nodal disease (pN3) emerged as the strongest independent predictor of worse OS. In HR-positive/HER2-negative breast cancer, pCR remains an uncommon outcome and is primarily associated with lower ER expression and higher proliferative activity. Although achieving pCR was independently associated with improved EFS, it did not independently predict OS within the current follow-up period. These findings suggest that pCR may be a useful surrogate endpoint for recurrence-related outcomes but should be interpreted cautiously as a marker of long-term survival in this subgroup. Quantitative assessment of ER expression and Ki-67 may help identify patients more likely to benefit from NAC. Further prospective studies with longer follow-up and external validation are warranted.</p>

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Prognostic impact of pathological complete response in hormone receptor–positive/HER2-negative breast cancer treated with neoadjuvant chemotherapy: a multicenter cohort study

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  • 发表日期：

    2026年8月1日

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  • Esma Uguztemur,
  • Ozgur Arici,
  • Esra Asik,
  • Ece Karanci,
  • Atila Yildirim

摘要

Pathological complete response (pCR) is an established surrogate endpoint in aggressive breast cancer subtypes; however, its prognostic role in hormone receptor (HR)-positive/HER2-negative disease remains controversial. We aimed to evaluate clinicopathological predictors of pCR and to investigate the prognostic impact of pCR on event-free survival (EFS) and overall survival (OS) in HR-positive/HER2-negative breast cancer treated with neoadjuvant chemotherapy (NAC). This multicenter retrospective cohort study included 379 patients with HR-positive/HER2-negative breast cancer treated with NAC between 2010 and 2025. ER and PR expression levels, Ki-67 index, and histopathological features were analyzed. Factors associated with pCR were evaluated using Firth penalized logistic regression. Survival outcomes were assessed using Kaplan–Meier analysis and Cox proportional hazards models. pCR was achieved in 18.7% of patients. Lower ER expression (≤ 10%) and higher Ki-67 (≥ 20%) were independently associated with increased likelihood of achieving pCR. In multivariate analysis, ER expression > 10% was associated with significantly lower odds of pCR, whereas Ki-67 ≥ 20% independently increased the probability of pCR. Achieving pCR was independently associated with improved EFS (HR range, 0.13–0.17 across models). Younger age and high Ki-67 were also independently associated with worse EFS, while lymphovascular invasion (LVI) retained prognostic significance in one multivariable model. In contrast, pCR was not independently associated with OS. Higher ER expression was consistently associated with improved OS, while advanced nodal disease (pN3) emerged as the strongest independent predictor of worse OS. In HR-positive/HER2-negative breast cancer, pCR remains an uncommon outcome and is primarily associated with lower ER expression and higher proliferative activity. Although achieving pCR was independently associated with improved EFS, it did not independently predict OS within the current follow-up period. These findings suggest that pCR may be a useful surrogate endpoint for recurrence-related outcomes but should be interpreted cautiously as a marker of long-term survival in this subgroup. Quantitative assessment of ER expression and Ki-67 may help identify patients more likely to benefit from NAC. Further prospective studies with longer follow-up and external validation are warranted.