Clinical Risk Stratification (CRS) for Colorectal Cancer Metastases

SUMMARY

• Metastases are the leading cause of death in solid state tumor patients and as such are commonly viewed as widespread and incurable. Despite this, an estimated 40-60% of patients only develop limited metastases that are amenable to surgical resection and chemotherapy. Therefore, a molecular basis for metastasis classification would have high clinical utility in better informing patient treatment plans and predicting outcomes.
• The inventors used algorithmic analysis of miRNA and mRNA networks in 93 colorectal cancer patients with liver metastases to classify metastatic disease into three distinct molecular sub-types. The sub-types were predictive of patient prognosis and further differed in histology, somatic mutations, and immune phenotype.
• The product is a test to stratify patients based on the pre-existing clinical risk scores (CRS) in combination with novel molecular determinants. The integrated CRS can be used to better inform treatment and outcomes in patients with colorectal cancer liver metastases.
• The molecular metastases classification was validated on a cohort of 96 colorectal cancer patients, independent from the cohort in which it was derived and was able to stratify patients in a statistically significant fashion (p<0.0001).