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Background <p>Adjuvant treatment decisions in ER+/HER2− breast cancer depend on accurate distinction between pN1 and pN2/3 disease. As sentinel lymph node biopsy (SLNB) increasingly replaces axillary lymph node dissection (ALND), patients with apparent pN1 disease may be understaged. We evaluated preoperative imaging and developed a composite risk score to identify patients for whom completion ALND might be omitted.</p> Methods <p>We retrospectively analyzed 160 ER+/HER2− patients with 1–3 positive sentinel nodes who underwent completion ALND after upfront surgery. Four imaging modalities were assessed for pN2/3 (≥4 positive nodes). A five-item composite score (SLN ≥ 2, lymphovascular invasion, tumor ≥2 cm, Ki-67 ≥20%, multifocality; range 0–5) underwent bootstrap validation and decision curve analysis (DCA).</p> Results <p>All four preoperative imaging modalities failed to predict pN2/3 under-staging (NPV 80–86%; all <i>p</i> ≥ 0.885). Overall, 17.5% harbored true pN2/3 on completion ALND. Low-risk patients (score ≤1; 32% of cohort) had a pN2/3 rate of only 3.9% (NPV 96.1%; sensitivity 92.9%) versus 23.9% in high-risk patients (<i>p</i> = 0.0015). DCA showed net benefit over a treat-all strategy across clinically relevant thresholds, corresponding to ~14 fewer unnecessary ALNDs per 100 patients.</p> Conclusions <p>Preoperative imaging showed limited sensitivity for pN2/3 under-staging and should not alone guide omission of completion ALND. A five-item composite score identified a low-risk subgroup (NPV 96.1%) in whom completion ALND might be omitted without compromising monarchE or RxPONDER decisions; prospective external validation is required before routine adoption.</p>

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Risk of pN2/3 Understaging in Sentinel Node-Positive ER+/HER2− Breast Cancer: A Composite Clinicopathologic Score for Safe RxPONDER and MonarchE Application

  • 期刊论文

  • 发表日期：

    2026年6月15日

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  • Soong June Bae,
  • Janghee Lee,
  • Sung-Im Do,
  • Eun Young Kim,
  • Chan Heun Park,
  • Yong Lai Park,
  • Ji-Sup Yun,
  • Kwan Ho Lee

摘要

Background

Adjuvant treatment decisions in ER+/HER2− breast cancer depend on accurate distinction between pN1 and pN2/3 disease. As sentinel lymph node biopsy (SLNB) increasingly replaces axillary lymph node dissection (ALND), patients with apparent pN1 disease may be understaged. We evaluated preoperative imaging and developed a composite risk score to identify patients for whom completion ALND might be omitted.

Methods

We retrospectively analyzed 160 ER+/HER2− patients with 1–3 positive sentinel nodes who underwent completion ALND after upfront surgery. Four imaging modalities were assessed for pN2/3 (≥4 positive nodes). A five-item composite score (SLN ≥ 2, lymphovascular invasion, tumor ≥2 cm, Ki-67 ≥20%, multifocality; range 0–5) underwent bootstrap validation and decision curve analysis (DCA).

Results

All four preoperative imaging modalities failed to predict pN2/3 under-staging (NPV 80–86%; all p ≥ 0.885). Overall, 17.5% harbored true pN2/3 on completion ALND. Low-risk patients (score ≤1; 32% of cohort) had a pN2/3 rate of only 3.9% (NPV 96.1%; sensitivity 92.9%) versus 23.9% in high-risk patients (p = 0.0015). DCA showed net benefit over a treat-all strategy across clinically relevant thresholds, corresponding to ~14 fewer unnecessary ALNDs per 100 patients.

Conclusions

Preoperative imaging showed limited sensitivity for pN2/3 under-staging and should not alone guide omission of completion ALND. A five-item composite score identified a low-risk subgroup (NPV 96.1%) in whom completion ALND might be omitted without compromising monarchE or RxPONDER decisions; prospective external validation is required before routine adoption.