June 2010 FINALLY Guidelines standards in testing from American College of Pathology and American Society for Clinical Oncology. See article below.
Assessment of Methods for Tissue-Based Detection of the HER-2/neu Alteration in Human Breast Cancer: A Direct Comparison of Fluorescence In Situ Hybridization and Immunohistochemistry
By Giovanni Pauletti, Suganda Dandekar, HongMei Rong, Lilllian Ramos, HongJun Peng, Ram Seshadri, Dennis J. Slamon
From the Department of Medicine, Division of Hematology-Oncology, University of California at Los Angeles, UCLA School of Medicine, Los Angeles, CA; and Flinders Medical Centre, Bedford Park, South Australia, Australia.
Address reprint requests to Dennis J. Slamon, MD, PhD, Division of Hematology and Oncology, UCLA School of Medicine, 11–934 Factor Bldg, Los Angeles, CA 90095-1678; email firstname.lastname@example.org.
PURPOSE: To compare the efficacy of fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) in detecting the HER-2/neu alteration in human breast cancer.
PATIENTS AND METHODS: Unselected stage I, II, and III breast cancer patients (N = 900) were tested for HER-2/neu gene amplification by FISH in paraffin-embedded, formalin-fixed archival material. Of these samples, 856 were tested for HER-2/neu overexpression by non–antigen-retrieval IHC with the polyclonal antibody R60, the sensitivity and specificity of which was preliminarily compared with the United States Food and Drug Administration–approved HercepTest (Dako Corp, Carpinteria, CA). Patient survival was analyzed in relation to the presence of the HER-2/neu alteration as determined by these two methodologies.
RESULTS: A total of 189 (21%) of 900 patients were positive by FISH and 147 (17.2%) of 856 were positive by IHC. This discrepancy is consistent with expected loss of IHC sensitivity associated with tissue fixation/embedding. The HercepTest did not improve sensitivity and introduced false positives. Comparison of R60-based IHC with FISH demonstrates that patient survival is associated progressively to gene amplification level as determined by FISH, whereas for IHC an association is found only in the highest (3+) immunostaining group. Among FISH-negative tumors, 45 (6.6%) of 678 were IHC-positive, with a survival probability similar to that of FISH-negative/IHC-negative cases; FISH-positive/IHC-negative patients have a survival probability similar to that of FISH-positive/IHC-positive cases.
CONCLUSION: IHC does not consistently discriminate patients likely to have a poor prognosis, whereas FISH provides superior prognostic information in segregating high-risk from lower-risk beast cancers. HER-2/neu protein overexpression in the absence of gene amplification occurs infrequently in breast cancer, in which case, patient outcome is similar to that of patients without the alteration.
Journal of Clinical Oncology, Vol 18, Issue 21 (November), 2000: 3651-3664
© 2000 American Society for Clinical Oncology
JCO, May 2001
Dangers of cardiotoxicity
Current Medical Research
Cardiac Dysfunction & Herceptin
Cardiotoxicity More Likely in Thin Women
Cardiotoxicity Concerns and Data Review
Herceptin Reduces BCa Recurrence in Some Women
Breast Cancer Res Treat, 7/03
DHA (Fish Oil) Downregulates Her-2/neu in Bca Cells
November 10, 2006
Cancer Res, October 2007
Annals of Oncology, 1/05
Olive Oil Suppresses HER-2neu Overexpression (Abstract)
Giacomo Castelvetro's salads. Anti-HER2 oncogene nutraceuticals since the 17th century?
New York Times article, June 2010
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