BlueCross BlueShield of Tennessee Medical Policy Manual

Ovarian Cancer Tumor Markers

DESCRIPTION

Tumor marker antigens can be detected in higher-than-normal amounts in the blood, urine, or body tissues of some individuals with certain types of cancer. A tumor marker may be produced by a tumor itself or by the body's response to the presence of cancer. A variety of substances, including enzymes, hormones, antigens, and proteins may be called tumor markers.

The use of tumor markers to diagnose cancer is limited at this time. Researchers are seeking markers that are specific to a particular type of cancer and detect the presence of cancer before symptoms appear.

Cancer antigen 125 (CA 125) is a high-molecular-weight protein antigen that is commonly elevated in individuals with known ovarian cancer. A rising CA 125 may be the initial sign of recurrent disease. Levels of CA 125 may also be elevated in nonmalignant conditions (e.g., pregnancy, endometriosis, pelvic inflammatory disease, benign ovarian masses).

POLICY

See also:  Serum Biomarker Human Epididymis Protein 4 (HE4)

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

There is a lack of high quality studies that support CA 125 measurement when used for screening for ovarian cancer, or the diagnosis of unknown pelvic or ovarian mass. 

SOURCES

American College of Obstetricians and Gynecologists. (2011, March). Committee opinion #477: the role of the obstetrician-gynecologist in the early detection of epithelial ovarian cancer. Retrieved February 12, 2016 from http://www.acog.org. 

Buys, S., Partridge, E., Black, A., Johnson, C., Camerato, L., Isaacs, C. et al. (2011). Effect of screening on ovarian cancer mortality. The prostate, lung, colorectal and ovarian (PLCO) cancer screening randomized controlled trial. Journal of American Medical Association, 305 (22), 2295-2303. (Level 1 evidence)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for tumor antigen by immunoassay - CA 125 (190.28). Retrieved February 12, 2016 from https://www.cms.gov.

Giuliani, M., Gui, B., Valentini, A., Giovanni, S., Miccò, M., Rodolfino, E. (2017, June) Early detection of recurrence or progression disease in patients with ovarian cancer after primary debulking surgery: a diagnostic challenge still unresolved. Correlation between CT findings and CA 125 levels. Minerva Ginecologic. June . doi: 10.23736/S0026-4784.17.04062-X. Abstract retrieved July 7, 2017 from PubMed database.

National Comprehensive Cancer Network. (2015, February). NCCN clinical practice guidelines in oncology (NCCN Guidelines ®). Ovarian cancer including fallopian tube cancer and primary peritoneal cancer. Retrieved July 7, 2017 from http://www.nccn.org.

National Institute for Health and Clinical Excellence. (2011, April). Ovarian cancer: the recognition and initial management of ovarian cancer. Retrieved May 30, 2012 from http://www.nice.org.uk/guidance/cg122.

Nguyen, A., Miller, E., Wichman, C., Berim, I., & Agrawal, D. (2015). Diagnostic value of tumor antigens in malignant pleural effusion: a meta-analysis. Translational Research: The Journal of Laboratory and Clinical Medicine, 166 (5), 432-439. Abstract retrieved February 12, 2016 from PubMed database.

Society of Gynecologic Oncologists. (2011, June). Posttreatment surveillance and diagnosis of recurrence with gynecologic malignancies: Society of Gynecologic Oncologists recommendations. Retrieved February 15, 2016 from http://www.ajog.org.

Sölètormos, G., Duffy, M., Hassan, S., Verheijen, R., Tholander, B., Bast, R., et al. (2016). Clinical use of cancer biomarkers in epithelial ovarian cancer. International Journal of Gynecological Cancer, 26 (1), 43-51. (Level 1 evidence)

U. S. Food and Drug Administration. (2009, April). Center for Devices and Radiological Health. P510(k) Premarket Notification Database. K080561. Retrieved June 1, 2012 from  http://www.accessdata.fda.gov.

U.S. Preventive Task Force. (2012). Screening for ovarian cancer: evidence update for the U.S. Preventive Services Task Force reaffirmation recommendation statement. Retrieved June 1, 2012 from http://www.uspreventiveservicestaskforce.org.

ORIGINAL EFFECTIVE DATE:  9/1998

MOST RECENT REVIEW DATE:  8/10/2017

ID_BT

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