This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Contact me when this article is cited  Related Content  • Related article  • Similar articles in JAMA  Topic Collections  • Oncology  • Breast Cancer  • Pathology & Laboratory Medicine  • Women's Health  • Women's Health, Other  • Alert me on articles by topic  Social Bookmarking   What's this?

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

In Reply: Drs Tubbs and Hicks argue that because of our deviation from the FDA-approved guidelines our test "becomes an in-house validated assay." We would first point out that the guidelines themselves have limitations, of which the FDA itself appears aware. In a recent briefing document, the FDA submitted that "the clinical benefit of trastuzumab was primarily seen in patients whose tumors were scored as IHC 3+."¹ But the FDA included the 2+ subgroup with the 3+ group for consideration for trastuzumab therapy. Subsequently, pivotal studies like that of Tubbs et al² showed that most of the 2+ scores by IHC are essentially false-positive. This supports the FDA Drug Advisory Committee’s initial predictions that the 2+ score may not be associated with the desired response to trastuzumab. Nonetheless, the FDA has not eliminated the 2+ score result as a requirement for eligibility to trastuzumab treatment despite evidence to the . . . [Full Text of this Article]

Hadi Yaziji, MD
hadiy@baptisthealth.net
Department of Pathology
Baptist Hospital of Miami
Miami, Fla

Todd S. Barry, MD, PhD; Allen M. Gown, MD
PhenoPath Laboratories
Seattle, Wash

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED ARTICLE

HER-2 Testing in Breast Cancer
Raymond R. Tubbs and David G. Hicks
JAMA. 2004;292(15):1817-1818.
EXTRACT | FULL TEXT