Hormone and HER2-receptor status in breast cancer: determination using sonographically guided core needle biopsy and correlation with excision specimen-a German single institution diagnostic accuracy study.

Abstract

Background: Sonographically guided core needle biopsy (CNB) is a well-established tool for diagnosing breast lesions. Preoperative estrogen receptor (ER), progesterone receptor (PR), and HER2-receptor status are essential for a personalized treatment approach.

Objectives: We evaluated the concordance of the hormone- and HER2-receptor status between the CNB and the surgical specimen to determine the accuracy of the CNB as a diagnostic method.

Design: This is a non-interventional retrospective study analyzing breast cancer patients treated at the breast care center of the University Medical Center Duesseldorf between January 2002 and December 2005.

Methods: Patients with paired CNB and surgical specimens and a diagnosis of invasive breast cancer were included. ER, PR, and HER2 status were determined by immunohistochemistry (IHC). Patients with IHC 2+ results were further examined by fluorescence in situ hybridization (FISH). Concordance of receptor status was calculated using specificity, sensitivity, and negative and positive predictive values.

Results: We found a very good agreement between CNB and surgical specimens regarding receptor status. A total of 248 patients were analyzed. Concordance rates in cases of primary surgery for ER, PR, and HER2 were 92.9%, 92.9%, and 93%, respectively. In cases of neoadjuvant chemotherapy, the concordance rates for ER, PR, and HER2 were 100%, 87.5%, and 96%, respectively.

Conclusion: CNB demonstrated high diagnostic accuracy compared with surgical specimens regarding ER, PR, and HER2-receptor status. Our findings support the recommendation to use sonographically guided CNB as the initial diagnostic method for guiding tailored treatment plans.