Serum Tumor Markers for Breast Malignancies
Serum tumor markers are substances 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 CEA, CA 15-3 and CA 27.29 have been investigated for monitoring advanced disease and to assist in determining whether to continue with a particular type of therapy, terminate its use, or switch to an alternative therapy.
Measurement of serum tumor markers for breast malignancies is considered medically necessary if medical appropriateness criteria are met.
Expanded serum tumor marker panels involving additional markers (i.e., beyond those considered medically appropriate) are considered investigational.
Measurement of any other serum tumor markers as a technique to diagnose, determine prognosis, select therapy or monitor for recurrence of breast malignancy is considered investigational.
Measurement of serum tumor markers for breast malignancy is considered medically appropriate if ALL of the following are met:
Serum tumor markers include ONE or MORE of the following:
Used to monitor treatment in individuals with advanced breast cancer (i.e., metastatic disease)
Used as an adjunctive assessment (i.e., in combination with radiology and clinical examination)
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Data are insufficient to recommend use of CEA, CA 15-3 and CA 27.29 alone for monitoring response to treatment.
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 December 22, 2017 from www.ascopubs.org.
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 December 22, 2017 from www.ascopubs.org.
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.
Centers for Medicare & Medicaid Services. CMS.gov. National Coverage Determination (NCD) for Carcinoembryonic antigen (190.26). Retrieved November 12, 2018 from https://www.cms.gov.
Centers for Medicare & Medicaid Services. CMS.gov. National Coverage Determination (NCD) for tumor antigen by immunoassay - CA 125 (190.28). Retrieved November 12, 2018 from https://www.cms.gov.
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)
Kos, T., Aksoy, S., Sendur, M.A., Arik, Z., Civelek, B., Kandemir, N., et al. (2013). Variations in tumor marker levels in metastatic breast cancer patients according to tumor subtypes. Journal of B.U.ON, 18 (3), 608-613. Abstract retrieved December 22, 2017 from PubMed database.
National Academy of Clinical Biochemistry. (2009). Use of tumor markers in testicular, prostate, colorectal, breast and ovarian cancers. Retrieved December 22, 2017 from https://www.aacc.org/science-and-practice/practice-guidelines/major-tumor-markers.
National Comprehensive Cancer Network. (2018, October). NCCN clinical practice guidelines in oncology (NCCN Guidelines®, Breast cancer - V 3.2018. Retrieved November 23, 2018 from the National Comprehensive Cancer Network.
Wang, W., Xu, X., Tian, B., Wang, Y., Du, L., Sun, T., et al. (2017). The diagnostic value of serum tumor markers CEA, CA19-9, CA125, CA15-3, AND TPS in metastatic breast cancer. Clinica Chimica Acta, 470, 51-55. Abstract retrieved December 22, 2017 from PubMed database.
ORIGINAL EFFECTIVE DATE: 9/1998
MOST RECENT REVIEW DATE: 2/14/2019
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