Genetic Testing for Tamoxifen Treatment
DESCRIPTION
Tamoxifen is prescribed as a component of adjuvant endocrine therapy to prevent endocrine receptor-positive breast cancer recurrence, as treatment of metastatic breast cancer, and to prevent disease in high-risk populations and in women with ductal carcinoma in situ (DCIS).
The cytochrome P450 (CYP) metabolic enzyme CYP2D6 has a major role in tamoxifen metabolism. The CYP2D6 gene is polymorphic with a variant DNA gene sequences resulting in proteins with a reduced or absent enzyme function. This may be associated with lower plasma levels of active tamoxifen metabolites, which could have an impact on tamoxifen treatment efficacy.
POLICY
Genetic testing for tamoxifen treatment is considered investigational.
IMPORTANT REMINDER
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.
ADDITIONAL INFORMATION
In the absence of any well-designed randomized controlled trials, the evidence is insufficient to permit conclusions regarding the use of CYP2D6 genotyping for women at high risk for or with breast cancer.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011). Genetic testing for tamoxifen treatment (2.04.51). Retrieved December 12, 2011 from BlueWeb. (40 articles and/or guidelines reviewed)
Burstein, H. J., Prestrud, A. A., Seidenfeld, J., Anderson, H., Bucholz, T. A., Davidson, N. E., et al. (2010). American Society of Clinical Oncology clinical practice guideline: Update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer. Journal of Clinical Oncology, 28 (23), 3784-3796.
Goetz, M. P., Kamal, A., & Ames, M. M. (2008). Tamoxifen pharmacogenomics: the role of CYP2D6 as a predictor of drug response. Clinical Pharmacology and Therapeutics, 83 (1), 160-166.
Khedhaier, A., Hassen, E., Bouaouina, N., Gabbouj, S., Ahmed, S. B., & Chouchane, L. (2008). Implication of xenobiotic metabolizing enzyme gene (CYP2E1, CYP2C19, CYP2D6, mEH and NAT2) polymorphisms in breast carcinoma. BMC Cancer, 8 (109). (Level 3 Evidence - Industry sponsored)
Kivotani, K., Mushiroda, T., Imamura, C. K., Hosono, N., Tsunoda, T., Kubo, M. et al. (2010). Significant effect of polymorphisms in CYP2D6 and ABCC2 on clinical outcomes of adjuvant tamoxifen therapy for breast cancer patients. Journal of Clinical Oncology, 28 (8), 1287-1293.
Lash, T. L., Lien, E. A., Sorensen, H. T., & Hamilton-Dutoit, S. (2009). Genotype-guided tamoxifen therapy: Time to pause for reflection? The Lancet Oncology, 10 (8), 825-833.
National Comprehensive Cancer Network. (2011, March). NCCN Guidelines for the Treatment of Cancer (NCCN Guidelines®) Breast cancer - V.2.2011. Retrieved December 15, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
National Guideline Clearinghouse. (2010, January). Diagnosis of breast disease. Retrieved December 13, 2011 from http://www.guidelines.gov.
Schroth, W., Antoniadou, L., Fritz, P., Schwab, M., Muerdter, T., Zanger, U. M., et al. (2007). Breast cancer treatment outcome with adjuvant tamoxifen relative to patient CYP2D6 and CYP2C19 genotypes. Journal of Clinical Oncology, 25 (33), 5187-5193.
Technology Evaluation Center. (2011). CYP2D6 pharmacogenomics of tamoxifen treatment. (Vol. 26). Chicago: BlueCross BlueShield Association. (1 article and/or guidelines reviewed)
U. S. Food and Drug Administration. (2004, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K042259. Retrieved May 20, 2008 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16034.
ORIGINAL EFFECTIVE DATE: 9/14/2008
MOST RECENT REVIEW DATE: 1/12/2012
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