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Quality Assurance in Her-2 Testing—Redefining the Gold Standard

¹ Department of Pathology, NHS Lothian, Western General Hospital, Edinburgh; the Edinburgh Breast Unit and the Breakthrough Breast Cancer Research Unit, Edinburgh, Scotland, UK.

^aAddress correspondence to the author at: Department of Pathology, NHS Lothian, Western General Hospital, Edinburgh, Scotland, UK. E-mail jeremy.thomas@luht.scot.nhs.uk.

The first 20% of the full text of this article appears below.

The landscape of testing for human epidermal growth factor receptor 2 (Her-2)¹ for breast cancer is changing rapidly. In 5 years we have moved from a test designed to predict the response to trastuzumab (Herceptin®) in patients with relapsed poor-prognosis disease to the position where deciding whether fit women with early breast cancer should be given adjuvant chemotherapy is based in part on this test result (1). Because adjuvant chemotherapy confers a survival benefit for approximately 10% of women treated and therefore produces little or no benefit and at least short- to medium-term harm to the other 90%, we need to be certain that our tests are reliable. It is also imperative that the laboratory data on which trial outcomes are judged are absolutely reliable. Sadly, this standard cannot be applied to Her-2 testing at the present time.

Xiao and colleagues in the current issue of the Journal (2) have laid out new standards for Her-2 testing that should pave the way for a stepwise increase in quality in this area and supply a paradigm for testing other therapeutically important indicators in cancer management.

A brief appraisal of current Her-2 testing practice worldwide will help to place the contribution of Xiao et al. in context. Her-2 testing is routinely carried out on primary breast cancers, either on the diagnostic core biopsy or on the excised tumor. Typically, such testing takes the form of an immunohistochemical (IHC) test on a tissue section, followed by fluorescence in situ . . . [Full Text of this Article]