BlueCross BlueShield of Tennessee Medical Policy Manual

Multi-gene Expression Assay for Predicting Recurrence in Colon Cancer

DESCRIPTION

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.

ColonPRS® (Signal Genetics) 163-gene expression test. Marketed for research use only.
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® (Genomic Health) 12-gene expression test

POLICY

See also: Expanded Molecular Panel Testing of Cancers to Identify Targeted Therapies

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

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.

SOURCES

Agency for Healthcare Research and Quality. (2012) Technical brief #13: gene expression profiling for predicting outcomes in stage II colon cancer. Retrieved June 9, 2016 from: www.ahrq.gov.

BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2016). Multigene expression assay for predicting recurrence in colon cancer (2.04.61). Retrieved July 12, 2017 from BlueWeb. (35 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.

Marisa, L., de Reynies, A., Duval, A., Selves, J., Gaub, M. P., Vescovo, L., et al. (2013). Gene expression classification of colon cancer into molecular subtypes: characterization, validation, and prognostic value. PLOS Medicine, 10 (5), 1-12.(Level 4 evidence)

National Comprehensive Cancer Network. (2017). Clinical practice guidelines in oncology (NCCN Guidelines®). Colon cancer v.2.2017. Retrieved July 12, 2017 from the National Comprehensive Cancer Network.

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:  8/10/2017

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