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.

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.