Diagnostic markers predictive of outcomes in colorectal cancer treatment and progression and methods of use thereof

摘要

Colorectal cancer patients with operable tumors must decide whether to receive adjuvant therapy after surgical resection in order to reduce their chances of recurrence. Current clinical guidelines are crudely based on the stage of the disease, as well as a few other clinicopathologic features. The instant invention integrates data from these clinicopathologic features with data on multiple biomarkers using advanced informatic methods to provide a far more accurate prediction of recurrence than the current guidelines. The instant invention consists of a panel of biomarker assays plus an algorithm into which the scored biomarker data, as well as standard clinicopathologic data, is entered. A tumor sample from an individual patient is submitted for test, and an individualized report is produced with a prognostic score that accurately reflects the patient's risk of recurrence. This helps guide the patient and his/her oncologist in their choice of whether to receive adjuvant treatment. Low-risk patients are spared the unnecessary toxicities associated with cytotoxic treatments, and high-risk patients are given the best chance for a cure, maximizing both life expectancy and quality of life.