HER2NEU Molecular Basis

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Breast Cancer Survivors

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HER2/NEU (C-erbB-2) gene amplification, HER2 protein overexpression, or both, are identified in 10% to 34% of invasive breast cancers.10 The ligand for the HER2/NEU protein receptor has not been identified, and its activation may occur through homo- and heterodimerization with other family members (EGFR, HER3, and HER4). Both morphologic and molecular techniques have been used to measure HER2/NEU status in breast cancer clinical samples (Table 24-1).11 The vast majority of these studies have linked either gene amplification or protein overexpression of HER2/NEU with adverse prognosis in either node-negative or node-positive disease.11 In general, when specimens have been carefully fixed, processed, and embedded, there has been excellent correlation between HER2/NEU gene copy status and protein expression levels.1114

Table 24-1. Comparison of Methods for HER2/NEU Detection in

Breast Cancer

Method

Target

FDA Status

Slide-Based

IHC

Protein

Approved*

Yes

FISH

DNA

Approvedt

Yes

Chromogenic in situ

DNA

Not approved

Yes

hybridization

(CISH)

Southern blot

DNA

Not approved

No

Reverse

mRNA

Not approved

No

transcription-

polymerase chain

reaction (RT-PCR)

Tumor enzyme-linked

Protein

Not approved

No

immunosorbent

assay (ELISA)

Serum ELISA

Protein

Approved!

No

*Two IHC methods are FDA approved for Herceptin selection

(Dako Herceptest and Ventana Pathway).

t One FISH method is approved for prognosis (Vent

ana Inform),

and one FISH method

is approved for prognosis and Herceptin

selection (Abbott-Vysis Pathvysion).

tSerum ELISA (Bayer Diagnostics, Tarrytown, NY) is FDA

approved for monitoring.

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