Serum Tumor Markers for Breast Malignancies
DESCRIPTION
Serum tumor markers are substances that are shed by certain tumors into circulation where they can be detected and measured. For breast cancer the serum tumor markers CA 15-3 and CA 27.29 associated with the MUC-1 gene have been investigated. Overexpression of the MUC 1 gene has been associated with certain cancers, in particular, breast, colon, lung, and pancreatic. Diagnosis of a suspected malignancy requires a tumor marker that is specific for a given tumor. Since most tumor markers are expressed both in normal, benign conditions as well as malignancies it is necessary to establish cut-off points to determine normal vs abnormal values. Two categories of clinical applications for serum tumor markers involve either a single measurement or serial measurements.
POLICY
Measurement of serum tumor markers, including but not limited to the following markers, as a technique to diagnose, determine prognosis, select therapy, or monitor for recurrence of breast cancer is considered investigational:
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See also:
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
CA 27.29 is a protein that is produced by the same gene (MUC-1) as CA 15-3. CA 27.29 is a newer test and may be less likely than CA 15-3 to read positive in non-cancerous situations. They are essentially equivalent and both use the same CPT code.
CA 125, a tumor marker for ovarian malignancies, is addressed in Ovarian Cancer Tumor Markers.
CEA (Carcinoembryonic antigen), a tumor marker for Gastrointestinal malignancies, is addressed in Serum Tumor Markers for Gastrointestinal Cancer.
No controlled studies were found in the published literature that validate the application of CA 27.29 and CA 15.3 tumor markers as a screening tool when symptoms are not present, or breast cancer tumor marker screening for diagnosis, monitoring or prognosis determination.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2011). Serum tumor markers for breast and gastrointestinal malignancies - Archived (2.03.02). Retrieved August 1, 2011 from BlueWeb. (20 articles and/or guidelines reviewed)
Burstein, H., Mangu, P., Somerfield, M., Schrag, D., Samson, D., holt, L., et al. (2011) American Society of Clinical oncology clinical practice guideline update on the use of chemotherapy sensitivity and resistance assays. Journal of Clinical Oncology, 2011 (36), 1 - 4.
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Tumor antigen by immunoassay CA 15-3/CA 27.29 (NCD 190.29, p. 2-19). Ingenix.
Duffy, M.J. (2006). Serum tumor markers in breast cancer: are they of clinical value? Clinical Chemistry, 52 (3), 345-351. (Level 5 Evidence )
National Comprehensive Cancer Network, (2011, February). NCCN clinical practice guidelines in oncology™. Breast cancer – V.2.2011. Retrieved July 25 ,2011 from http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
National Guideline Clearinghouse. (2007, October). American Society of Clinical Oncology 2007 update recommendations for the use of tumor markers in breast cancer. Retrieved April 17, 2008 from http://www.guidelines.gov.
National Guideline Clearinghouse. (2009). National Academy of Clinical Biochemistry laboratory practice guideline: Use of tumor markers in testicular, prostate, colorectal, breast and ovarian cancers. Retrieved July 25, 2011 from http://www.guidelines.gov.
National Institute for Health and Clinical Excellence. (2009, February). Early and locally advanced breast cancer: diagnosis and treatment. Retrieved August 1, 2011 from http://www.nice.org.uk/nicemedia/live/12132/43413/43413.pdf.
Rack, B., Schindlbeck, C., Jückstock, J., Genss, E.M., Hepp, P., Lorenz, R., et al. (2010). Prevalence of CA 27.29 in primary breast cancer patients before the start of systemic treatment. Anticancer Research, 30 (5), 1837-1841. (Level 1 Evidence – Independent study)
Saad, A., Kanate, A., Sehbai, A., Marano, G., Hobbs, G., & Abraham, J. (2008). Correlation among [18F]fluorodeoxyglucose positron emission tomography/computed tomography, cancer antigen 27.29, and circulating tumor cell testing in metastatic breast cancer. Clinical Breast Cancer, 8 (4), 357 -361. (Level 4 Evidence – Independent study)
U. S. Food and Drug Administration. (2007, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071675. Retrieved January 5, 2010 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=25126.
ORIGINAL EFFECTIVE DATE: 9/1998
MOST RECENT REVIEW DATE: 12/10/2011
ID_BA
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