| Title: |
Reliability of core needle biopsy for HER2-low early-stage breast cancer |
| Authors: |
Ciniselli, C. M.; Verderio, P.; Duroni, V.; Baili, P.; Pizzamiglio, S.; de Braud, F. G.; Folli, S.; Depretto, C.; Scaperrotta, G.; De Santis, M. C.; Carnevale, M. G.; De Marco, C.; Vingiani, A.; Pruneri, G.; Di Cosimo, S. |
| Contributors: |
Associazione Italiana per la Ricerca sul Cancro; European Commission |
| Source: |
Clinical and Translational Oncology ; volume 27, issue 8, page 3340-3345 ; ISSN 1699-3055 |
| Publisher Information: |
Springer Science and Business Media LLC |
| Publication Year: |
2025 |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1007/s12094-025-03877-2 |
| DOI: |
10.1007/s12094-025-03877-2.pdf |
| DOI: |
10.1007/s12094-025-03877-2/fulltext.html |
| Availability: |
https://doi.org/10.1007/s12094-025-03877-2; https://link.springer.com/content/pdf/10.1007/s12094-025-03877-2.pdf; https://link.springer.com/article/10.1007/s12094-025-03877-2/fulltext.html |
| Rights: |
https://creativecommons.org/licenses/by/4.0 ; https://creativecommons.org/licenses/by/4.0 |
| Accession Number: |
edsbas.86217AC3 |
| Database: |
BASE |