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Background/Objective <p>Patients with clinically advanced node-positive (cN2/3), non-metastatic breast cancer have traditionally undergone axillary lymph node dissection (ALND) after neoadjuvant systemic therapy (NST). Randomized de-escalation trials have excluded cN2/3 disease. However, some of these patients achieve nodal pathologic complete response (ypN0), suggesting potential for less extensive axillary surgery. We aimed to determine ypN0 rates and identify factors associated with nodal response.</p> Methods <p>The National Cancer Database (NCDB, 2004–2022) was analyzed. Female patients with cN2/3, non-metastatic breast cancer who received neoadjuvant chemotherapy (NAC) followed by surgery were included. Patients were stratified by pathologic nodal status. Clinicopathologic variables were compared, and multivariable logistic regression identified factors associated with pathologic complete response (pCR). Overall survival was analyzed using Kaplan–Meier methods.</p> Results <p>Among approximately 4 million patients with breast cancer, 20,402 met the inclusion criteria. Of these, 36.9% (<i>n</i>&#xa0;=&#xa0;7526) achieved ypN0 and 63.1% (<i>n</i>&#xa0;=&#xa0;12,876) had residual nodal disease. ypN0 was associated with younger age (52 vs 54 years), higher Ki-67 (67% vs 42%), and higher tumor grade (37% vs 21% vs 11% for grades 3, 2, and 1, respectively; <i>p</i>&#xa0;&lt;&#xa0;0.001). Higher ypN0 rates were observed in human epidermal growth factor receptor 2–positive (70%), hormone receptor-negative (62%), and triple-negative tumors (57%), whereas hormone receptor-positive tumors had lower ypN0 rates (29%). Overall, pCR occurred in 22.6%. Despite this, 60.8% underwent ALND. Multivariable analysis showed that higher Ki-67 (odds ratio [OR] 1.29), younger age (OR 0.99 per year), and hormone receptor-negative status (OR 0.24) were associated with pCR (<i>p</i>&#xa0;&lt;&#xa0;0.001). pCR and ypN0 were associated with improved OS (hazard ratio 0.31 and 0.39, respectively; <i>p</i>&#xa0;&lt;&#xa0;0.001).</p> Conclusion <p>Over one-third of patients achieved ypN0 after NST. These findings highlight an opportunity to refine axillary management in selected cN2/3 patients.</p>

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Nodal Pathologic Response After Neoadjuvant Systemic Therapy in Clinically Advanced Node-Positive (cN2 and cN3) Breast Cancer

  • 期刊论文

  • 发表日期：

    2026年7月8日

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  • Diana M. Jaen,
  • Collin E. Dougherty,
  • Kimberly A. Helseth,
  • Paige A. Harwell,
  • Juan A. Santamaria-Barria,
  • Janelle-Cheri Millen

摘要

Background/Objective

Patients with clinically advanced node-positive (cN2/3), non-metastatic breast cancer have traditionally undergone axillary lymph node dissection (ALND) after neoadjuvant systemic therapy (NST). Randomized de-escalation trials have excluded cN2/3 disease. However, some of these patients achieve nodal pathologic complete response (ypN0), suggesting potential for less extensive axillary surgery. We aimed to determine ypN0 rates and identify factors associated with nodal response.

Methods

The National Cancer Database (NCDB, 2004–2022) was analyzed. Female patients with cN2/3, non-metastatic breast cancer who received neoadjuvant chemotherapy (NAC) followed by surgery were included. Patients were stratified by pathologic nodal status. Clinicopathologic variables were compared, and multivariable logistic regression identified factors associated with pathologic complete response (pCR). Overall survival was analyzed using Kaplan–Meier methods.

Results

Among approximately 4 million patients with breast cancer, 20,402 met the inclusion criteria. Of these, 36.9% (n = 7526) achieved ypN0 and 63.1% (n = 12,876) had residual nodal disease. ypN0 was associated with younger age (52 vs 54 years), higher Ki-67 (67% vs 42%), and higher tumor grade (37% vs 21% vs 11% for grades 3, 2, and 1, respectively; p < 0.001). Higher ypN0 rates were observed in human epidermal growth factor receptor 2–positive (70%), hormone receptor-negative (62%), and triple-negative tumors (57%), whereas hormone receptor-positive tumors had lower ypN0 rates (29%). Overall, pCR occurred in 22.6%. Despite this, 60.8% underwent ALND. Multivariable analysis showed that higher Ki-67 (odds ratio [OR] 1.29), younger age (OR 0.99 per year), and hormone receptor-negative status (OR 0.24) were associated with pCR (p < 0.001). pCR and ypN0 were associated with improved OS (hazard ratio 0.31 and 0.39, respectively; p < 0.001).

Conclusion

Over one-third of patients achieved ypN0 after NST. These findings highlight an opportunity to refine axillary management in selected cN2/3 patients.