BlueCross BlueShield of Tennessee Medical Policy Manual

Serum Tumor Markers for Gastrointestinal Cancer

DESCRIPTION

Serum tumor markers are substances produced by cells in response to cancer or certain noncancerous conditions. Most tumor markers are made by normal cells as well as cancer cells; however, they are produced at much higher levels in cancerous conditions.  These substances can be found in blood, urine, stool, tumor tissue, or other tissues or bodily fluids. 

Carcinoembryonic antigen (CEA) is a glycoprotein found in high levels in those individuals with colorectal cancers (CRC). CEA is used to monitor response to treatment and to detect disease recurrence.  CA 19-9 monitors recurrence or metastases in pancreatic cancer. 

POLICY

See also: Serum Tumor Markers for Breast Malignancies

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Current data are insufficient to recommend CA 19-9 for screening, diagnosis, staging, surveillance or monitoring treatment of individuals with colorectal cancer.  CA 19-9’s low positive predictive value makes it a poor biomarker for pancreatic cancer screening. CEA is not recommended as a screening test for colorectal cancer.

SOURCES  

American Society of Clinical Oncology. (2006). ASCO 2006 update of recommendations for the use of tumor markers in gastrointestinal cancer. Retrieved August 9, 2016 from http://jco.ascopubs.org/content/24/33/5313.long.

American Society of Colon and Rectal Surgeons. (2012). Practice parameters for the management of colon cancer. Retrieved August 9, 2016 from the National Guideline Clearinghouse (NGC: 009295).

Ballehaninna, U.K., & Chamberlain, R.S. (2012). The clinical utility of serum CA 19-9 in the diagnosis, prognosis and management of pancreatic adenocarcinoma: an evidence based appraisal. Journal of Gastrointestinal Oncology, 2012,3 (2), 105-119. DOI:10.3978/j.issn.2078-6891.2011.021. (Level 2 evidence)

Bauer, T., El-Rayes, B., Li, X., Hammad, N., Philip, P., Shields, A., et al. (2013). Carbohydrate antigen 19-9 is a prognostic and predictive biomarker in patients with advanced pancreatic cancer who receive gemcitabine-containing chemotherapy: a pooled analysis of 6 prospective trials. Cancer, 119 (2), 285-292. (Level 2 evidence)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for carcinoembryonic antigen (190.26). Retrieved September 29, 2015 from https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=118&ncdver=1&DocID=190.26&from2=search.asp&bc=gAAAABAAAAAAAA%3d%3d&.

Centers for Medicare & Medicaid Services. CMS.gov. NCD for tumor antigen by immunoassay – CA 19-9 (190.30). Retrieved September 29, 2015 from https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=142&ncdver=1&DocID=190.30&from2=search.asp&bc=gAAAABAAAAAAAA%3d%3d&.

Huang, Z., & Liu, F. (2014). Diagnostic value of serum carbohydrate antigen 19-9 in pancreatic cancer: a meta-analysis. Tomour Biology, 35 (8), 7459-7465. Abstract retrieved August 26, 2016 from PubMed database.

Humphris, J., Chang, D., Johns, A., Scarlett, C., Pajic, M., Jones, M. (2012). The prognostic and predictive value of serum CA19.9 in pancreatic cancer. Annals of Oncology, 23, 1713-1722. (Level 2 evidence)

National Comprehensive Cancer Network. (2016). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Pancreatic adenocarcinoma. Version 1.2016. Retrieved August 9, 2016 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2016). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Gastric cancer. Version 3.2016. Retrieved August 18, 2016 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2016). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Colon cancer. Version 2.2016. Retrieved August 9, 2016 from the National Comprehensive Cancer Network.

National Institute for Health and Care Excellence. (2011). Colorectal cancer: diagnosis and management. Retrieved August 9, 2016 from www.nice.org.uk/guidance/cg131.

Osayi, S., Bloomston, M., Schmidt, C., Ellison, E., & Muscarella, P. (2014). Biomarkers as predictors of recurrence following curative resection for pancreatic ductal adenocarcinoma: a review. Biomed Research International, 2014:468959. Doi: 10.1155/2014/468959. Epub 2014 Jun 24.  (Level 2 evidence)

Primrose, J., Perera, R., Gray, A., Rose, P., Fuller, A., Corkhill, A., et al. (2014). Effect of 3 to 5 years of scheduled CEA and CT follow-up to detect recurrence of colorectal cancer: the FACS randomized clinical trial. Journal of American Medical Association, 311 (3), 263-270. (Level 2 evidence)

Sorensen, C., Karisson, W., Pommergaard, H., Burcharth, J., & Rosenberg, J. (2016). The diagnostic accuracy of carcinoembryonic antigen to detect colorectal cancer recurrence – a systematic review. International Journal of Surgery, 25, 134-144. Abstract retrieved August 9, 2016 from PubMed database.

Verberne, C., Zhan, Z., van den Heuvel, E., Grossmann, I., Doornbos, P., Havenga, K., et al. (2015). Intensified follow-up in colorectal cancer patients using frequent carcino-embryonic antigen (CEA) measurements and CEA-triggered imaging: results of the randomized “CEAwatch” trial. EJSO, 41, 1181-1196.  (Level 2 evidence)

ORIGINAL EFFECTIVE DATE:  11/1987

MOST RECENT REVIEW DATE:  2/12/2017

ID_BT

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