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Expert analysis of HER2 tests reveals issues with reliability, Mayo Clinic researchers say
Date:12/11/2010

udy's lead investigator, Edith Perez, M.D. (http://mayoresearch.mayo.edu/staff/perez_ea.cfm), deputy director of Mayo Clinic Cancer Center (http://cancercenter.mayo.edu/) in Florida.

The findings suggest that patients with multiple tumor samples who test normal for HER2 in one block should consider having the other tumor sample tested, Dr. Perez says. Most oncologists take and store more than one tumor block from their patients, but it is not clear who would fund testing of the second tumor sample, she adds.

This analysis continues the investigation into the reliability of HER2 protein (immunohistochemistry) and gene (fluorescence in situ hybridization, or FISH) tests that Dr. Perez has led since 2001. She and her team published a study in 2002 that found the disagreement between local and central laboratories that analyze these tests was between 15 and 20 percent. Central laboratories process more than 100 patient tumors per year and local labs perform fewer than that amount.

In this study, Dr. Perez wanted to know whether pathologists in the central laboratory agree more often with each other than they do with pathologists at local laboratories.

All three teams of pathologists conducted a blinded review of samples from 389 patients who had been enrolled in three adjuvant clinical trials (N8931, BCIRG005, and BCIRG006) in which HER2 testing was performed by local and central laboratories to determine if patients were candidates for these studies. Each of the three central laboratories received at least six slides from a patient's tumor block that the laboratory used to retest HER2 gene and protein levels.

The goals were to analyze how often the two tests agreed with each other between the laboratories; determine whether an "adjudication" process could resolve cases that don't agree; ascertain whether two samples fro
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Contact: Nicole Engler
newsbureau@mayo.edu
507-284-5005
Mayo Clinic
Source:Eurekalert

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