BlueCross BlueShield of Tennessee Medical Policy Manual

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. Diagnosis of a suspected malignancy requires a tumor marker that is specific for a given tumor. For breast cancer the serum tumor markers CA 15-3 and CA 27.29 have been investigated. Clinical applications for serum tumor markers involve either a single measurement or serial measurements. Due to their very low sensitivity and specificity as well as to the fact that serum markers can be elevated in some benign conditions their usefulness in diagnosis and/or screening has not been demonstrated.

POLICY

 
  • BCM

  • CA 27.29

  • CAM-26

  • MCA

 
  • Beta hcG

  • CA 125

  • CAM-29

  • MSA

 
  • CA 15.3

  • CA 549

  • CEA

  • TPA

See also:  

IMPORTANT REMINDERS

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 the Ovarian Cancer Tumor Markers medical policy.

CEA (Carcinoembryonic antigen), a tumor marker for gastrointestinal malignancies, is addressed in the Serum Tumor Markers for Gastrointestinal Cancer medical policy.

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 

American Society of Clinical Oncology. (August, 2015). Use of biomarkers to guide decisions on systemic therapy for women with metastatic breast cancer: American Society of Clinical Oncology clinical practice guideline. Retrieved January 4, 2017 from the National Guideline Clearinghouse (NGC: 010780).

American Society of Clinical Oncology. (March, 2013). Breast cancer follow-up and management after primary treatment: American Society of Clinical Oncology clinical practice guideline update. Retrieved October 9, 2014 from http://www.guidelines.gov.  (NGC: 010353).

Bidard, F. C., Hajage, D., Bachelot, T., Delaloge, S., Brain, E., Campone, M., et al. (2012). Assessment of circulating tumor cells and serum markers for progression-free survival prediction in metastatic breast cancer: A prospective observational study. Breast Cancer Research, 14 (1), 1-10. (Level 2 evidence - Industry sponsored)

Centers for Medicare & Medicaid Services. CMS.gov. National Coverage Determination (NCD) for tumor antigen Immunoassay - CA 15-3/CA 27.29 (190.29). Retrieved January 27, 2016 from https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=134&.

Centers for Medicare & Medicaid Services. CMS.gov. National Coverage Determination (NCD) for tumor antigen Immunoassay - CA 125 (190.28). Retrieved January 27, 2016 from https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=130&.

Chung, L., & Baxter, R. C. (2012). Breast cancer biomarkers: proteomic discovery and translation to clinically relevant assays. Expert Reviews Proteomics, 9 (6), 599-614. (Level 5 evidence – Independent)

Dong, X., Yang, M., Sun, H., Lu, J., Zheng, Z., Li, Z., et al. (2013). Combined measurement of CA 15-3 with novel autoantibodies improves diagnostic accuracy for breast cancer. Onco Targets and Therapy, 6, 273-279. (Level 4 evidence - Independent)

Fu, Y., & Li, H. (2016). Assessing clinical significance of serum CA15-3 and carcinoembryonic antigen (CEA) levels in breast cancer patients: A meta-analysis. Medical Science Monitor, 2016, 22, 3154-3162. (Level 1 evidence - Independent)

Ghadge, M. S., Naik, P. P., Tiwari, B. P., Hegde, R. M., & Matale, T. J. (2012). A comparative study of bone scan findings and serum levels of tumor marker CA 15-3 in patients with breast carcinoma. Indian Journal of Clinical Biochemistry, 27 (1), 97-99. (Level 3 evidence)

Henderson, M. C., Hollingsworth, A. B., Gordon, K., Silver, M., Mulpuri, R., Letsios, E., et al. (2016). Integration of serum protein biomarker and tumor associated autoantibody expression data increases the ability of a blood-based proteomic assay to identify breast cancer. PLoS ONE, 1-9. (Level 2 evidence)

Liu, Y., Liao, Y., Xiang, L., Jiang, K., Li, S., Huangfu, M., et al. (2016). A panel of autoantibodies as potential early diagnostic serum biomarkers in patients with breast cancer. International Journal of Clinical Oncology, Epub ahead of print. Abstract retrieved January 5, 2017 from PubMed database.

Mirabelli, P., & Incoronato, M. (2013). Usefulness of traditional serum biomarkers for management of breast cancer patients. BioMed Research International, Volume 2013, Article ID 685641, 1-9. (Level 1 evidence)

Misek, D. E., & Kim, E. H. (2011). Protein biomarkers for the early detection of breast cancer. International Journal of Proteomic.  2011 (343582), 1-9. (Level 5 evidence - Independent)

National Academy of Clinical Biochemistry. (2009). Use of tumor markers in testicular, prostate, colorectal, breast and ovarian cancers. Retrieved April 30, 2013 from http://guideline.gov/content.aspx?id=15553&search=serum+tumor+markers.

National Comprehensive Cancer Network. (2016). NCCN clinical practice guidelines in oncology™, Breast cancer - V 1.2016. Retrieved January 27, 2016 from http://www.nccn.org. 

National Institute for Health and Clinical Excellence (NICE). (2009, February). Early and locally advanced breast cancer: diagnosis and treatment. Retrieved April 30, 2013 from http://www.nice.org.uk.  

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)

U. S. Food and Drug Administration. (2007, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071675. Retrieved April 30, 2013 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071675.pdf.

U. S. Food and Drug Administration. (2007, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071729. Retrieved October 10, 2014 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/k071729.pdf.  

Xu, X., Wan, J., Yuan, L., Ba, J., Feng, P., Long, W., et al. (2016). Serum levels of apolipoprotein E correlates with disease progression and poor prognosis in breast cancer. Tumour Biology, Epub ahead of print. Abstract retrieved January 4, 2017 from PubMed database.

ORIGINAL EFFECTIVE DATE:  9/1998

MOST RECENT REVIEW DATE:  2/9/2017

ID_BT

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