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Background <p>The reliability of core needle biopsy (CNB) for HER2-positive breast cancer is well established. However, data on HER2-low and the potential for inconsistencies with surgical samples are limited.</p> Materials and methods <p>Concordance between CNB and surgical samples was assessed using the unweighted Cohen kappa statistic (Kc) in a consecutive series of 776 treatment-naïve early-stage breast cancer patients. Logistic regression models were used to evaluate the association between concordance and clinico-pathological features.</p> Results <p>The agreement for HER2-positive status between CNB and surgical specimens was high at 95%, with a Kc value of 0.86 indicating almost perfect agreement. However, 65 of 123 (53%) cases initially classified as HER2-0 were reclassified as HER2 1 + or 2 + /ISH-negative, and 89 of 374 (24%) cases initially classified as HER2 1 + /2 + were HER2-0 in surgical samples. This resulted in a Kc value of 0.22, indicating fair agreement in classifying HER2-0 versus HER2-low breast cancer. Tumor size was a significant factor influencing discordance, with tumors larger than 2&#xa0;cm having double the risk of misclassification.</p> Conclusion <p>These findings suggest that HER2 status should be retested, particularly for large tumors initially diagnosed as HER2-0, in light of new effective therapies for HER2-low breast cancer, such as antibody–drug conjugates.</p>

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Reliability of core needle biopsy for HER2-low early-stage breast cancer

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月9日

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  • C. M. Ciniselli,
  • P. Verderio,
  • V. Duroni,
  • P. Baili,
  • S. Pizzamiglio,
  • F. G. de Braud,
  • S. Folli,
  • C. Depretto,
  • G. Scaperrotta,
  • M. C. De Santis,
  • M. G. Carnevale,
  • C. De Marco,
  • A. Vingiani,
  • G. Pruneri,
  • S. Di Cosimo

摘要

Background

The reliability of core needle biopsy (CNB) for HER2-positive breast cancer is well established. However, data on HER2-low and the potential for inconsistencies with surgical samples are limited.

Materials and methods

Concordance between CNB and surgical samples was assessed using the unweighted Cohen kappa statistic (Kc) in a consecutive series of 776 treatment-naïve early-stage breast cancer patients. Logistic regression models were used to evaluate the association between concordance and clinico-pathological features.

Results

The agreement for HER2-positive status between CNB and surgical specimens was high at 95%, with a Kc value of 0.86 indicating almost perfect agreement. However, 65 of 123 (53%) cases initially classified as HER2-0 were reclassified as HER2 1 + or 2 + /ISH-negative, and 89 of 374 (24%) cases initially classified as HER2 1 + /2 + were HER2-0 in surgical samples. This resulted in a Kc value of 0.22, indicating fair agreement in classifying HER2-0 versus HER2-low breast cancer. Tumor size was a significant factor influencing discordance, with tumors larger than 2 cm having double the risk of misclassification.

Conclusion

These findings suggest that HER2 status should be retested, particularly for large tumors initially diagnosed as HER2-0, in light of new effective therapies for HER2-low breast cancer, such as antibody–drug conjugates.