Multi-gene Expression Assay for Predicting Recurrence in Colon Cancer
Does Not Apply to Commercial Genetic Testing Program effective 6/1/2018
Multi-gene expression assays are proposed for use as prognostic markers in stage II or stage III colon cancer to identify individuals who are at high risk for recurrent disease and those who could be candidates for adjuvant chemotherapy. The majority of individuals with stage II colon cancer (75%-80%) are cured by surgery alone, and the absolute benefit of chemotherapy for the overall population is small. Individuals most likely to benefit from chemotherapy are difficult to identify by standard clinical and pathologic risk factors. Genomic tests are proposed to facilitate the identification of those individuals. For individuals with stage III colon cancer, the current standard treatment includes six months of adjuvant chemotherapy after primary surgical treatment.
Currently there are several multi-gene expression assays being marketed for clinical use in the United States.
|ColoPrint® (Agendia)||18-gene Colon Cancer Recurrence Assay|
|GeneFx™ (Helomics)||634 probe set (482 gene) signature|
|OncoDefender-CRC™ (Everist Genomics)||5-gene test|
|Oncotype DX® Colon Cancer Assay (Genomic Health)||12-gene expression test|
Multi-gene expression assays for determining the prognosis of stage II and stage III colon cancer following surgery are considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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Current evidence is insufficient to permit conclusions on how gene expression classification compares with other approaches for identifying recurrence in individuals with stage II or III colon cancer. Studies showing management changes as a consequence of testing do not demonstrate whether such changes improve outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.
BlueCross BlueShield Association. Evidence Positioning System. (7:2018). Multigene expression assay for predicting recurrence in colon cancer (2.04.61). Retrieved March 25, 2019 from http://www.evidencepositioningsystem.com. (22 articles and/or guidelines reviewed)
Brenner, B., Geva, R., Rothney, M., Beny, A., Dror, Y., Steiner, M., et al. (2016). Impact of the 12-gene colon cancer assay on clinical decision making for adjuvant therapy in stage II colon cancer patients. Value Health, 19 (1), 82-87. Abstract retrieved July 12, 2017 from PubMed database.
Kopetz, S., Tabernero, J., Rosenberg, R., Jiang, Z., Moreno, V., Bachleitner-Hofmann, T. (2015). Genomic classifier Coloprint predicts recurrence in stage II colorectal cancer patients more accurately than clinical factors. The Oncologist, 20 (2), 127-133. (Level 4 evidence)
National Comprehensive Cancer Network. (2019, March). NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Colon cancer v.1.2019. Retrieved March 25, 2019 from the National Comprehensive Cancer Network.
Palmetto Government Benefit Administrators. (2018). MolDx. Oncotype DX colon cancer assay coding and billing guidelines (M0002, v15). Retrieved June 13, 2018 from PubMed database.
Reimers, M., Kuppen, P., Lee, M., Lopatin, M., Tezcan, H., Putter, H. et al. (2014). Validation of the 12-gene colon cancer recurrence score as a predictor of recurrence risk in stage II and III rectal cancer patients. Journal of the National Cancer Institute, 106 (11). DOI:10.1093/jnci/dju269. (Level 3 evidence)
Srivastava, G., Renfro, L., Behrens, R., Lopatin, M., Chao, C., Soori, G., et al. (2014). Prospective multicenter study of the impact of Oncotype DX colon cancer assay results on treatment recommendations in stage II colon cancer patients. The Oncologist, 19, 492-497. (Level 4 evidence)
Yothers, G., O’Connell, M., Lee, M., Lopatin, M., Clark-Langone, K., Millward, C., et al. (2013). Validation of the 12-gene colon cancer recurrence score in NSABP C-07 as a predictor of recurrence in patients with Stage II and III colon cancer treated with Fluorouracil and Leucovorin (FU/LV) and FU/LV plus Oxaliplatin. Journal of Clinical Oncology, 31 (36), 4512-4519. (Level 3 evidence)
ORIGINAL EFFECTIVE DATE: 10/9/2010
MOST RECENT REVIEW DATE: 5/9/2019
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