Detection and Quantification of Circulating Tumor Cells in the Management of Individuals with Cancer
DESCRIPTION
Studies have suggested that the presence of circulating tumor cells in individuals with metastatic carcinoma is associated with short survival. Quantifying circulating tumor cells might be a useful technique to provide an immediate assessment of response to chemotherapy rather than relying on changes in imaging studies (i.e., computed tomography scans). Finally, the presence of circulating tumor cells has been investigated as an additional prognostic factor in women with breast cancer without metastases, which could be used to determine the need for additional adjuvant chemotherapy. The CellSearch™ System (Veridex) is an example of such a technology. The technique involves identification of the circulating tumor cells, which are tagged using antibody-coated magnetic beads that recognize cell surface antigens. The cells are then labeled with fluorescent dyes, which can then be quantified by a semiautomated fluorescent-based microscopy system.
Veridex LLC, a Johnson & Johnson company, markets the CellSearch™ System. It uses automated instruments manufactured by Immunicon Corp. for sample preparation (Cell Tracks® AutoPrep) and analysis (CellSpotterAnalyzer®), together with supplies, reagents, and epithelial cell control kits manufactured by Veridex. The technology has received U.S. Food and Drug Administration (FDA) marketing clearance through the 510(k) process for monitoring metastatic breast cancer (January 2004), for monitoring metastatic colorectal cancer (November 2007), and for monitoring metastatic prostate cancer (February 2008).
POLICY
Detection and quantification of circulating tumor cells in the management of cancer is considered investigational.
ADDITIONAL INFORMATION
In the absence of well-designed randomized controlled trials, no conclusions can be drawn about whether the detection and quantification of circulating tumor cells in the management of individuals with cancer has an effect on health outcomes.
SOURCES
Allard, W. J., Matera, J., Miller, M. C., Repollet, M., Connelly, M. C., Rao, C., et al. (2004). Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects of patients with nonmalignant diseases. Clinical Cancer Research, 10 (20), 6897-6904.
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2009). Detection of circulating tumor cells in the management of patients with cancer (2.04.37). Retrieved April 20, 2010 from BlueWeb.
Braun, S., & Marth, C. (2004). Circulating tumor cells in metastatic breast cancer - toward individualized treatment? The New England Journal of Medicine, 351 (8), 824-826.
Cristofamilli, M., Budd, G. T., Ellis, M. J., Stopeck, A., Matera, J., Miller, M. C., et al. (2004). Circulating tumor cells, disease progression, and survival in metastatic breast cancer. The New England Journal of Medicine, 351 (8), 781-791.
Cristofanilli, M., Hayes, D. F., Budd, G. T., Ellis, M. J., Stopeck, A., Reuben, J. M., et al. (2005). Circulating tumor cells: A novel prognostic factor for newly diagnosed metastatic breast cancer. Journal of Clinical Oncology, 22 (7), 1420-1430.
U. S. Food and Drug Administration. (2004, January). Center for Devices and Radiological Health. 510(k) summary. Retrieved November 16, 2004 from http://www.fda.gov/cdrh/MDA/DOCS/K031588.html.
ORIGINAL EFFECTIVE DATE: 5/12/2005
MOST RECENT REVIEW DATE: 5/13/2010
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