Comparing Herceptin Tests-

FISH better

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 dslamon@mednet.ucla.edu.

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


Discrepancies in Tests/False Positives

JCO, May 2001

Wait 22 weeks Before Using Anthracylines After Herceptin

Dangers of cardiotoxicity

From HER2 to Herceptin (Trastuzumab)

MEDSCAPE, 9/01

References
Contra-indications for Herceptin Use

Current Medical Research and Opinion,2001

Cardiac Dysfunction & Herceptin
Cardiotoxicity More Likely in Thin Women
WARNING: Taxol & Herceptin (Metastatic Breast Cancer)

NCI 4/02/02

Cardiotoxicity Concerns and Data Review
Assay Predicts Response to Herceptin Therapy

May, 2002

Some Recent Statements on Her2/Herceptin

Posted 9/30/02

Herceptin Reduces BCa Recurrence in Some Women
Herceptin & Central Nervous System Mets

Cancer, 6/03

Platinum-Taxane w/Herceptin

Breast Cancer Res Treat, 7/03

Docetaxol &Trastuzumab  BIG BENEFITS

SABCS, 12/03

DHA (Fish Oil) Downregulates Her-2/neu in Bca Cells
Gamma-linolenic Acid BOOSTS Effectiveness of Herceptin

JNCI, 11/05

Adjuvant Herceptin: Am Soc of Breast Disease Statement

Press Release, November 10, 2006 www.asbd.org

Trastuzumab-Resistant HER2-Driven Breast CaCells Sensitive to Epigallocatechin-3 Gallate

Cancer Res, October 2007

Olive Oil Cuts Levels of Her-2/neu

Annals of Oncology, 1/05

Olive Oil Suppresses HER-2neu Overexpression (Abstract)
Giacomo Castelvetro's salads. Anti-HER2 oncogene nutraceuticals since the 17th century?
Am College Pathology & ASCO Set Standards for HER2neu Testing

New York Times article, June 2010


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