Prognostic markers in breast cancer: the reliability of HER2/neu status in core needle biopsy of 325 patients with primary breast cancer.

Author(s): Taucher S, Rudas M, Mader RM, Gnant M, Dubsky P, Roka S, Bachleitner T, Kandioler D, Steger G, Mittlböck M, Jakesz R

Publication: Wien Klin Wochenschr, 2004, Vol. 116, Page 26-31

PubMed ID: 15030120 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to determine the effects of using CNB versus SE to assess HER2 status by IHC staining. Contrary to other studies, the authors determined HER2 positive cases to be only those scoring a 3+ using the HercepTest, while those scoring a 0, 1+, or 2+ were deemed to be HER2 negative. CNB that were HER2 positive by IHC staining (3+), but HER2 negative with the SE were also evaluated by fluorescence in situ hybridization (FISH). Both CNB and SE were fixed in 4.5% neutral buffered formalin. The median length of time between CNB and SE acquisition was 25 days.

   Summary of Findings:

   Overall accuracy of HER2 status determination in CNB was 92%, while sensitivity and specificity were 81% and 95%, respectively. While 57 of 312 CNB specimens were determined to be HER2 positive, only 44 of the corresponding SE specimens were also HER2 positive. The remaining 13 SE were HER2 0, 1+, or 2+. FISH analysis agreed with the negative HER2 status determined for the SE in 11 of 13 cases. 10 of the 255 CNB determined to be HER2 negative had corresponding SE that were HER2 positive. The authors state that crushing CNB at the edge led to more intense staining and edge artifacts. The authors report no differences in the accuracy of HER2 status determination between patients who received chemotherapy between CNB and SE acquisition and those that did not.

   Biospecimens

   • Tissue - Breast

   Preservative Types

   • Formalin

   Diagnoses:

   • Neoplastic - Carcinoma

   Platform:

   Analyte	Technology Platform
   Protein	Immunohistochemistry
   DNA	FISH

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Immunohistochemistry Specific	Technology platform	FISH
   Preaquisition	Other drugs	Neoadjuvant chemotherapy No chemotherapy
   Biospecimen Acquisition	Method of tissue acquisition	Core needle biopsy Surgical resection

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