Cancer Treatment Today » Tumor Markers

CEA for Mucinous Ovarian Cancer – pro

M Levin, MD — Mon, 02 Jul 2012 15:38:49 +0000

Carcinoembryonic antigen (CEA) is a glycoprotein whose serum concentration is often elevated in cancers of the gastrointestinal tract, breast, lung and in gynecological malignancies (Tuxen et al. 1999). CEA is elevated in approximately 34–37% of the patients with ovarian cancer and more often in mucinous (88%) than in non-mucinous (19%) cancers (Bast et al. 1984, Tholander et al. 1990, Stenman et al. 1995, Tuxen et al. 1995). Serial CEA determinations can be used to predict prognosis in ovarian cancer. Declining or persistently low CEA levels are associated with a better prognosis than high or rising levels. Thus, for mucinous ovarain cancer, as a unique type of ovarain cancer, CEA monitoring is reasonable.

Tumor Markers: Physiology, Pathobiology, Technology, and Clinical Applications By Eleftherios P. Diamandis5, 41 pages
ISBN 1890883719

Equivocal Her/2Neu Test by FISH: What to do? – pro

M Levin, MD — Mon, 02 Jul 2012 15:36:14 +0000

Determination of HER-2/neu status has thus taken on great importance in the routine work-up of breast cancer in the pathology laboratory:over-expression of the protein product of HER-2/neu gene is usually a direct consequence of gene amplification, in which multiple copies of the gene appear throughout the genome. The two most widely used technologies are immunohistochemistry (IHC) and FISH, because these two techniques are ideal for use on paraffin embedded tissue, including archival material. FISH is considered the gold standard for HER2 assessment and correlates best with outcome and response to traztuzamab treatment.While FISH detects gene amplification, IN+HC detects gene product overexpression.

The technology used is Vysis Pathvysion, with the result of amplification of HER in ration of >2.2:1. According to the test makers (http://www.abbottmolecular.com/PathVysionHER2DNAProbeKit_5138.aspx), specimens with amplification showed a LSI HER-2/neu and CEP 17 signal ratio of greater than or equal to 2.0; normal specimens showed a ratio of less than 2.0. Results at or near the cut-off point (1.8-2.2) should be interpreted with caution. I understand this to mean that this is an equivocal HER test.

It is not known how to deal with equivocal FISH results. The ASCO/CAP guidelines and the PathVysion HER-2 DNA Probe Kit package insert recommend counting additional cells as a step toward resolving equivocal HER2 amplification status. However it does not always resolve the issue and exposing a patient to year of Herceptin in such a situation would be considered experimental.

As an unproven treatment, Herceptin in this situation should be considered not med. necessary when HER/2Neu test is equivocal.

Bast RC Jr, Ravdin P, Hayes DF, et al. 2000 update of recommendations for the use of tumor markers in breast and colorectal cancer: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol. 2001;19:1865-1878.

Carlson RW, Moench SJ, Hammond ME, et al. HER2 testing in breast cancer: NCCN Task Force report and recommendations. J Natl Compr Canc Netw. 2006;4(suppl 3):S1-S24.
Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007;25:118-145. 2013 Update: http://www.cancer.net/publications-and-resources/asco-care-and-treatment-recommendations-patients/her2-testing-breast-cancer

Serum Her Test – pro

M Levin, MD — Mon, 02 Jul 2012 15:34:29 +0000

The Serum HER-2/neu Test is a test that can track a woman’s HER-2/neu level once she is diagnosed with MBC regardless of whether the treatment is hormone therapy, chemotherapy or trastuzumab-based therapy because it is a serum biomarker for HER-2/neu positive tumors. Recent clinical studies have also shown that up to 40% of breast cancer patients who had HER-2/neu negative tumors at first diagnosis later became HER-2/neu positive.(iv) The Serum HER-2/neu Test allows physicians to identify patients whose original tissue biopsies were HER-2/neu negative, not tested, not available for testing, or were stored for a long period of time, but who subsequently become positive after their cancers have spread. It is a more recent test and it ahs not been validated vis-a-vvis tumor HER testing in rpedicting the effect of Herceptin.

A recent review concludes: “On the basis of our review of the literature, we conclude that there is currently insufficient evidence to support the use of serum HER-2 ECD in the routine management of individual patients with breast cancer. This conclusion is in agreement with the 2007 American Society of Clinical Oncology guidelines on the use of biomarkers in breast cancer. ” This test cannot serve as the basis for approving Herceptin in lieu or against HER/2neu results on teh tunor specimen.

Leary, Alexandra F., Hanna, Wedad M., van de Vijver, Marc J., Penault-Llorca, Frederique, Ruschoff, Josef, Osamura, Robert Y., Bilous, Michael, Dowsett, Mitch
Value and Limitations of Measuring HER-2 Extracellular Domain in the Serum of Breast Cancer Patients
J Clin Oncol 2009 27: 1694-1705