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Human Epidermal Growth Factor Receptor 2 Testing Recommendation

Pathology Core Facility-ECOG PCO, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL

To the Editor:

The human epidermal growth factor receptor 2 (HER-2) testing recommendations are long overdue. It is welcome news to see such a great deal of effort put into standardizing breast cancer tests. Without a doubt, these recommendations will transform the current focus of preanalytic, analytic, and postanalytic tissue testing. Thanks to the panel members for their efforts in a very challenging environment. There is definitely more work to be done.

The urgency to get more work done is driven mostly by the eagerness of clinicians and their patients to obtain expeditious evidence-based laboratory results. The other area of medical sciences that is relying on the results of such recommendations is molecular gene expression profiling.

Regarding preanalytic testing, everyone should be aware that rather than performing resections, more and more laboratories are performing HER-2 assays on biopsies. Alarmingly, however, most of these biopsies are fixed and processed immediately, which provides less than 1 hour for fixation and about 2 hours for processing.

With these recent findings, it is important not to compare HER-2 expression in resection specimens with that of biopsies until a concrete, head-to-head comparison is done using these recommendations.

It is also important to point out that using cell lines as controls is not the same as using human tissue, mainly because of texture, which may or may not affect the protein structural expression. Again, more work must be done in this area.

Overall, the HER-2 recommendations are a start, and in time, need to be mandated via agencies such as the College of American Pathologists, with supporting head-to-head comparison data.

AUTHOR'S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.

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  Antonio C. Wolff, M. Elizabeth H. Hammond, Jared N. Schwartz, Daniel F. Hayes, and On behalf of the ASCO/CAP Panel on HER-2 Testing in Breast Cancer
  JCO 2007 25: 4021-4023 [Full Text]

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• American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer
  Antonio C. Wolff, M. Elizabeth H. Hammond, Jared N. Schwartz, Karen L. Hagerty, D. Craig Allred, Richard J. Cote, Mitchell Dowsett, Patrick L. Fitzgibbons, Wedad M. Hanna, Amy Langer, Lisa M. McShane, Soonmyung Paik, Mark D. Pegram, Edith A. Perez, Michael F. Press, Anthony Rhodes, Catharine Sturgeon, Sheila E. Taube, Raymond Tubbs, Gail H. Vance, Marc van de Vijver, Thomas M. Wheeler, and Daniel F. Hayes
  JCO 2007 25: 118-145 [Abstract] [Full Text]

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