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DESCRIPTIONA 12-gene expression test (Oncotype DX® colon cancer test; Genomic Health, Inc., Redwood City, CA) has been developed to predict the likelihood of disease recurrence for patients with stage II colon cancer following surgery.
Of patients with stage II colon cancer, 75-80% are cured by surgery alone, and the absolute benefit of chemotherapy for the patient population is small. Those patients who are most likely to benefit from chemotherapy are difficult to identify by standard clinical and pathological risk factors. The 12-gene expression test is intended to be used as an aid in indentifying those stage II patients most likely to experience recurrence after surgery and therefore those most likely to benefit from additional treatment.
Colorectal cancer is classified stage II when it has spread outside the colon and/or rectum to nearby tissue, but is not detectable in the lymph nodes and has not metastasized to distant sites (also called Dukes B). The primary treatment is surgical resection of the primary cancer and colonic anastomosis. After surgery the prognosis is very good, with survival rates of 75% to 80% at 5 years. Meta-analysis of several trials of adjuvant therapy vs. surgery alone in stage II patients found statistically significant, although small, absolute benefit of chemotherapy for disease-free survival but not for overall survival. Therefore, adjuvant chemotherapy with 5-fluorouracil (5-FU) or capecitabine is recommended only as an option for resected patients with high-risk stage II disease (i.e. those. with poor prognostic features). However, the clinical and pathological features used to identify high-risk disease are not well-established and the patients for whom the benefits of adjuvant chemotherapy would most likely outweigh the harms cannot be identified with certainty. The current system relies on a variety of factors, including tumor substage 2B (T4A tumors that invade the muscularis propria and extend into pericolorectal tissues) or 2C (T4B tumors that invade or are adherent to other organs or structures), obstruction or bowel perforation at initial diagnosis, an inadequately low number of sampled lymph nodes at surgery (≤12), histologic features of aggressiveness, a high preoperative carcinoembryonic antigen level, and indeterminate or positive resection margins.
Of interest, a recent review has noted that microsatellite instability (MSI) and mismatch repair (MMR) deficiency in colon cancer may represent confounding factors to be considered in treatment. These factors may identify a small proportion (15%-20%) of the population with improved DFS who may derive no benefit or may exhibit deleterious effects from adjuvant fluorouracil/leucovorin-based treatments. Patient MSI and MMR status may be critically important in how to study, interpret, and use a particular GEP test.
The 12-gene expression test was launched by Genomic Health as the Oncotype DX® colon cancer test in January 2010. The test has not been submitted to or cleared for marketing by the U.S. Food and Drug Administration (FDA). The test is offered as a laboratory-developed assay service conducted in the CLIA-licensed Genomic Health clinical laboratory.
The Oncotype DX® breast cancer test is addressed in the Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer medical policy.
POLICYThe 12-gene expression test (Oncotype DX® colon cancer test) is considered investigational, including use for predicting the likelihood of disease recurrence for patients with stage II colon cancer following surgery.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/22/2010: Approved by Medical Policy Advisory Committee
06/21/2011: Policy reviewed; no changes.
11/10/2011: Policy reviewed; no changes.
09/25/2012: Policy reviewed; no changes.
11/15/2013: Policy reviewed; no changes.
11/04/2014: Policy reviewed; description updated. Policy statement unchanged.
08/04/2015: Code Reference section updated for ICD-10.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.04.61
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.