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Purpose <p>Investigation of ‘HER2-ultralow’ prevalence and the effects of HER2 status (HER2-null vs. HER2-ultralow) on prognosis in patients with early-stage (non-metastatic) breast cancer.</p> Methods/patients <p>This single-center, retrospective study analyzed 424 patients with early-stage, CerbB2 immunohistochemistry (IHC) score 0 breast cancer. Pathological re-review classified tumors as HER2-ultralow (≤ 10% of tumor cells with faint, incomplete membrane staining) or HER2-null (no staining). The cohorts were stratified by estrogen receptor (ER) status into ER + (≥ 1%) and triple-negative breast cancer (TNBC) groups.</p> Results <p>This study included 235 ER + and 189 TNBC patients. HER2-ultralow frequency was 30.6% (<i>n</i> = 72) in the ER + group and 18% (<i>n</i> = 34) in the TNBC group. In the ER + group, higher Ki67 and increasing stage were associated with worse 5&#xa0;year disease-free survival (DFS) (<i>p</i> = 0.006 and <i>p</i> &lt; 0.001, respectively), while HER2 status had no significant effect on 5-year DFS (<i>p</i> = 0.269). In the TNBC group, HER2-ultralow patients had worse 5-year DFS than HER2-null patients (67% vs. 74.1%, <i>p</i> = 0.048). In multivariate analysis, HER2 status was a statistically significant prognostic factor [(HR: 0.34 (0.145–0.841), <i>p</i> = 0.019)]. Despite a numerically worse 5&#xa0;year overall survival (OS) rate in HER2-ultralow versus HER2-null patients (73.2% vs. 79.5%), the difference was statistically insignificant (<i>p</i> = 0.114).</p> Conclusions <p>In TNBC, HER2-ultralow was a poor prognostic factor associated with inferior 5&#xa0;year DFS compared to HER2-null, while no difference was observed in the ER + cohort. These findings suggest that HER2-ultralow status may identify a TNBC subgroup that warrants novel therapies, such as T-DXd, although validation in larger studies is needed.</p>

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Investigation of the prevalence of HER2-ultralow and the effects of HER2 status (HER2-null vs. HER2-ultralow) on survival in HER2-negative early-stage breast cancer

  • 期刊论文

  • 发表日期：

    2025年10月24日

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  • Alper Türkel,
  • Sultan Çiğdem Irkkan,
  • İlknur Deliktaş Onur,
  • Cengiz Karaçin

摘要

Purpose

Investigation of ‘HER2-ultralow’ prevalence and the effects of HER2 status (HER2-null vs. HER2-ultralow) on prognosis in patients with early-stage (non-metastatic) breast cancer.

Methods/patients

This single-center, retrospective study analyzed 424 patients with early-stage, CerbB2 immunohistochemistry (IHC) score 0 breast cancer. Pathological re-review classified tumors as HER2-ultralow (≤ 10% of tumor cells with faint, incomplete membrane staining) or HER2-null (no staining). The cohorts were stratified by estrogen receptor (ER) status into ER + (≥ 1%) and triple-negative breast cancer (TNBC) groups.

Results

This study included 235 ER + and 189 TNBC patients. HER2-ultralow frequency was 30.6% (n = 72) in the ER + group and 18% (n = 34) in the TNBC group. In the ER + group, higher Ki67 and increasing stage were associated with worse 5 year disease-free survival (DFS) (p = 0.006 and p < 0.001, respectively), while HER2 status had no significant effect on 5-year DFS (p = 0.269). In the TNBC group, HER2-ultralow patients had worse 5-year DFS than HER2-null patients (67% vs. 74.1%, p = 0.048). In multivariate analysis, HER2 status was a statistically significant prognostic factor [(HR: 0.34 (0.145–0.841), p = 0.019)]. Despite a numerically worse 5 year overall survival (OS) rate in HER2-ultralow versus HER2-null patients (73.2% vs. 79.5%), the difference was statistically insignificant (p = 0.114).

Conclusions

In TNBC, HER2-ultralow was a poor prognostic factor associated with inferior 5 year DFS compared to HER2-null, while no difference was observed in the ER + cohort. These findings suggest that HER2-ultralow status may identify a TNBC subgroup that warrants novel therapies, such as T-DXd, although validation in larger studies is needed.