Serum Tumor Markers for Gastrointestinal Cancer
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.
Serum tumor markers for the treatment of gastrointestinal cancer are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Serum tumor markers for the treatment of other gastrointestinal cancers are considered investigational.
The use of serum tumor markers is considered medically appropriate if ANY ONE of the following are met:
CA 19-9 is indicated when ALL the following are met:
In the management of pancreatic adenocarcinoma
Postoperatively to assess for recurrence or metastatic disease
Prior to initiation of adjuvant therapy
Carcinoembryonic antigen (CEA) testing is indicated for ALL of the following:
In the management of colorectal cancer as indicated by ANY ONE of the following:
Preoperatively to assist in staging and surgical planning
Postoperative follow-up interval of ANY ONE of the following:
First two years post resection, every three to six months
Three to five years post resection, every six months
Follow-up CEA testing not to exceed five years post resection
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
Current data are insufficient to recommend additional biomarkers, such as CA 72 and CA 125 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.
American Society of Clinical Oncology. (2006). Update of recommendations for the use of tumor markers in gastrointestinal cancer. Retrieved August 9, 2016 from www.jco.ascopubs.org.
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. National Coverage Determination (NCD) for carcinoembryonic antigen (190.26). Retrieved September 29, 2015 from https://www.cms.gov.
Centers for Medicare & Medicaid Services. CMS.gov. National Coverage Determination (NCD) for tumor antigen by immunoassay – CA 19-9 (190.30). Retrieved September 29, 2015 from https://www.cms.gov.
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. (2017, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Colon cancer. Version 2.2017. Retrieved October 18, 2017 from www.nccn.org.
National Comprehensive Cancer Network. (2017, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Rectal cancer. Version 3.2017. Retrieved October 18, 2017 from www.nccn.org.
National Comprehensive Cancer Network. (2017, October). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Gastric cancer. Version 5.2017. Retrieved October 18, 2017 from www.nccn.org.
National Comprehensive Cancer Network. (2017, September). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Pancreatic adenocarcinoma. Version 3.2017. Retrieved October 18, 2017 from www.nccn.org.
National Institute for Health and Care Excellence. (2011). Colorectal cancer: diagnosis and management. Retrieved October 18, 2017 from www.nice.org.uk.
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.
Sun, Z.and Zhang, N. (2015) Clinical evaluation of CEA, CA19-9, CA72-4 and CA125 in gastric cancer patients with neoadjuvant chemotherapy. World Journal of Surgical Oncology, 12 (1), 397. (Level 4 evidence)
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: 12/14/2017
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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