CONCLUSIONS: To the authors' knowledge, the 5-gene rule (OncoDefender-CRC) is the first molecular prognostic that has been validated in both stage I CRC and stage II colon cancer. It outperforms standard clinicopathologic prognostic criteria and obviates the need to retrieve 12 lymph nodes for accurate prognostication. It identifies those patients most likely to develop recurrent disease within 3 years after curative surgery and, thus, those most likely to benefit from adjuvant treatment.
Patients identified by OncoDefender-CRC as having high recurrence risk are likely to benefit from more aggressive treatment options from the start. Independent studies have demonstrated a significant improvement in overall survival rates for high-risk Stage I and Stage II colorectal cancer patients receiving adjuvant therapy within 60 days following surgical resection of their tumor. No other currently available molecular diagnostic test approaches the performance capabilities of OncoDefender-CRC in this regard.