Circulating Tumor DNA (Liquid Biopsy) and Circulating Tumor Cells
Detection and quantification of circulating tumor DNA (ctDNA) also referred to as ‘liquid biopsy’, and circulating tumor cells (CTCs) in peripheral blood, has been proposed as a noninvasive alternative to tissue biopsy. The presence of CTCs (e.g., CellSearch® CTC) and ctDNA (e.g., Oncotype SEQ™, Guardant360®) has been documented in multiple tumor types, such as breast, prostate, lung, and colorectal carcinomas.
Both normal and tumor cells release DNA fragments into the blood. Studies have shown variable results for clinical sensitivity and it is not known to what degree genetic variances detected by ctDNA are representative of the primary tumor.For individuals who have cancer or are at high risk of developing cancer who receive identification and quantification of CTCs, cutoff levels that should be used to signal a change in patient management are unknown.
Detection and quantification of circulating tumor cells and circulating tumor DNA (liquid biopsy) in the management of individuals with any type of cancer or for assessing the risk of cancer is considered investigational.
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The uncertainties concerning clinical validity and preclude conclusions about whether genetic variance analysis by ctDNA can replace analysis in tissue samples. The evidence is insufficient to determine the effects of the technology on health outcomes, therefore using liquid biopsy or the analysis of circulating tumor cells as a method to predict or manage any type of cancer remains investigational at this time.
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BlueCross BlueShield Association. Medical Policy Reference Manual (10:2016) Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management (Liquid Biopsy) Retrieved June 20, 2017 from BlueWeb. (43 articles and/or guidelines reviewed)
Cahaba Government Benefit Administrators, LLC. (2015, October) Local Coverage Determination (LCD: for Pathology and laboratory: circulating tumor cells (CTC) assays (L34273). Retrieved February 17, 2017 from https://www.cms.gov
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Matsusaka, S., Chin, K., Ogura, M., Suenaga, M., Shinozaki, E., Mishima, Y., et al. (2010). Circulating tumor cells as a surrogate marker for determining response to chemotherapy in patients with advanced gastric cancer. Cancer Science, 101 (4), 1067-1071. (Level 3 evidence - Industry sponsored)
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Qiu, M., Wang, J., Xu, Y., Ding, X., Li, M., Jiang, F., et. al., (2015, January) Circulating tumor DNA is effective for the detection of EGFR mutation in non-small cell lung cancer: a meta-analysis. Cancer Epidemiology, Biomarkers & Prevention; 24(1):206-12. Abstract retrieved June 20, 2017 from PubMed database.
Rack, B., Schindlbeck, C., Jückstock, J., Andergassen, U., Hepp, P., Zwingers, T., et al. (2014, May). Circulating tumor cells predict survival in early average-to-high risk breast cancer patients. Oxford Journal, 106 (5), 1-11. (Level 3 evidence)
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Tanaka, F., Yoneda, K., Kondo, N., Hashimoto, M., Takuwa, T., Matsumoto, S., et al. (2009). Circulating tumor cell as a diagnostic marker in primary lung cancer. Clinical Cancer Research, 15 (22), 6980-6986. (Level 3 evidence - Independent study)
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Wang, S., Du, H., & Li, G. (2017). Significant prognostic value of circulating tumor cells in esophageal cancer patients: A meta-analysis. Oncotarget, Advance Publications, 2017, 1-12. (Level 3 evidence - Independent study)
Wu, Z. X., Liu, Z., Jiang, H. L., Pan, H. M., & Han, W. D. (2016). Circulating tumor cells predict survival benefit from chemotherapy in patients with lung cancer. Oncotarget, 7 (41), 67586-67596. Abstract retrieved February 17, 2017 from PubMed database.
Zheng, Y., Zhang, C., Wu, J., Cheng, G., Yang, H., Hua, L., et al. (2016). Prognostic value of circulating tumor cells in castration resistant prostate cancer: A meta-analysis. Urology Journal, 13 (6), 2881-2888. Abstract retrieved February 17, 2017 from PubMed Database.
ORIGINAL EFFECTIVE DATE: 5/12/2005
MOST RECENT REVIEW DATE: 10/1/2017
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