Korean J Lab Med.  2008 Oct;28(5):392-399. 10.3343/kjlm.2008.28.5.392.

Availability of Fine Needle Aspirates for the Assessment of HER2 Gene Amplification in Invasive Breast Cancer Patients

• Lee JW
• Noh WC
• Kim MS
• Kim HA
• Chang YH
• Hong YJ
• Hong SI
• Lee JK

• KMID: 1781572
• DOI: http://doi.org/10.3343/kjlm.2008.28.5.392

Abstract

BACKGROUND: FISH and immunohistochemistry (IHC) on formalin-fixed paraffin embedded (FFPE) tissue are currently used in the clinical laboratory to determine HER2 status in invasive breast cancer patients. Since tissue-based methods are relatively time-consuming and have a limitation for standardization of procedure, we evaluated the availability of fine needle aspirates (FNA) for the assessment of HER2 status in invasive breast cancer patients.
METHODS
FNA were obtained from 51 invasive breast cancer patients and were submitted for the evaluation of HER2 status. After invasive breast cancer components were ascertained by morphological evaluation, HER2 gene amplification was evaluated by FISH. The results of HER2 FISH on FNA cells were compared with those of both FISH and IHC on corresponding FFPE tissues. FISH results were interpreted by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines issued in 2007.
RESULTS
Of 51 FNA specimens, one was excluded due to an insufficient number of cancer cells for tests. Excluding the cases that showed 'equivocal' results, 47 (98%) out of 48 cases were concordant between the results of FISH on FNA and FISH on corresponding FFPE tissue (kappa, 0.969), and 43 (93%) out of 46 cases were concordant between the results of FISH on FNA and IHC on corresponding FFPE tissue (kappa, 0.912).
CONCLUSIONS
An excellent correlation was found between FISH on FNA cells and corresponding FFPE sections. We recommend FNA specimens for more rapid determination of HER2 status by FISH, which will be helpful for patient selection for individualized therapy.

Keyword

HER2; Fine needle aspirates; FISH

MeSH Terms

Adult
Aged
Aged, 80 and over
Biopsy, Fine-Needle
Breast Neoplasms/genetics/metabolism/*pathology
Carcinoma, Ductal, Breast/genetics/metabolism/pathology
Female
Gene Amplification
Humans
Immunohistochemistry
In Situ Hybridization, Fluorescence
Middle Aged
Paraffin Embedding
Receptor, erbB-2/*genetics/metabolism
Reproducibility of Results

Figure

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  Fig. 1. Invasive cancer cell components of a primary breast cancer: cancer cells have round nucleus with abnormal chromatin pattern and large, prominent nucleoli (Giemsa stain, ×1,000).

• 

  Fig. 2. Examples of HER2 FISH for invasive breast cancer patients. (A) FISH on fine needle aspirates (FNA). The respective cancer cells are distinctly observed and clustered multiple orange signals indicate HER2 gene amplification (× 1,000). (B) FISH on formalin fixed paraffin embedded (FFPE) tissue. The overlapped cancer cells are frequently observed and the intact nuclei are occasionally observed in a nonamplified breast cancer (× 1,000).

• 

  Fig. 3. An example of positive HER2 immunohistochemical stain on formalin fixed paraffin embedded (FFPE) tissue. Strong, complete membrananous staining (3+) is observed in all cells of an invasive breast cancer (Hematoxylin counterstaining,×400).

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