BlueCross BlueShield of Tennessee Medical Policy Manual

Serum Tumor Markers for Gastrointestinal Cancer

DESCRIPTION

Serum tumor markers are substances that are shed by certain tumors into circulation where they can be detected and measured. Carcinoembryonic antigen (CEA) is a glycoprotein found in high levels in those individuals with colorectal cancers (CRC) and has been investigated as a tumor marker for CRC. Other gastrointestinal tumor markers that have been studied are those related to mucinous glycoproteins. The mucinous glycoproteins of the gastrointestinal tract include CA 19-9, CA 242, and CA 72-4, The marker may be expressed by the tumor itself or the body in response to the presence of a tumor. 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.

Serum tumor markers have been investigated in a wide variety of malignancies to detected disease recurrence and/or progression of the disease. This policy focuses on tumor markers for gastrointestinal malignancies, including, colon, rectal, gastric and pancreatic cancers.

POLICY

See also:  Serum Tumor Markers for Breast Malignancies

MEDICAL APPROPRIATENESS 

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Published scientific evidence in the form of well-designed studies in peer-reviewed journals regarding the utilization of tumor markers for the treatment and management of gastrointestinal cancers is lacking. There is insufficient evidence to permit conclusions regarding improvement in net health outcomes.

SOURCES 

BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2011). Serum tumor markers for breast and gastrointestinal. (2.03.02). Retrieved February 25, 2014 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]. (2013, November). Carcinoembryonic antigen (CEA) (NCD 190.26, p. 2-143 thru 2-146). OptumInsight, Inc.

Complete Guide to Medicare Coverage Issues [Computer software]. (2013, November). Tumor antigen by immunoassay CA 19-9 (NCD 190.30, p 2-152 thru 2-154). OptumInsight, Inc.

Ivankovics, I., Fernandes, L., Saad, S., & Matos, D. (2008). Peripheral and mesenteric serum levels of CEA and cytokeratins, staging and histopathological variables in colorectal adenocarcinoma. World Journal of Gastroenterology, 14 (43), 6699 - 6703. (Level 2 Evidence)

Kim, J., Kim, N., Sohn, S., Kim, Y., Kim, K.., Hur, H., et al. (2009) Prognostic value of postoperative CEA clearance in rectal cancer patients with high preoperative CEA levels. Annals of Surgical Oncology, 16 (10), 2771 - 2778. (Level 2 Evidence)

Locker, G. Y., Hamilton, S., Harris, J., Jessup, J. M., Kemeny, N., Macdonald, J. S., et al. (2006). ASCO 2006 update of recommendations for the use of tumor markers in gastrointestinal cancer. Journal of Clinical Oncology, 24 (33), 5313-5327.

National Cancer Institute. (2013). Colon cancer treatment (PDQ®).Retrieved February 25, 2014 from http://www.cancer.gov/cancertopics/pdq/treatment/colon/HealthProfessional.

National Comprehensive Cancer Network. (2014, March). NCCN clinical practice guidelines in oncology™.Colon cancer (V.3.2014). Retrieved February 25, 2014 from http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf.

National Comprehensive Cancer Network. (2014, January). NCCN clinical practice guidelines in oncology™.  Pancreatic adenocarcinoma (V.1.2014). Retrieved February 25, 2014 from  http://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf.

U. S. Food and Drug Administration. (2008. July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K072901. Retrieved July 27, 2011 from: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072901.pdf.

ORIGINAL EFFECTIVE DATE: 11/1987

MOST RECENT REVIEW DATE:  5/22/2014

ID_BA

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.

This document has been classified as public information.