New Option for Colorectal Cancer Patients
About Predictor C for UICC Stage II and UICC Stage III Colorectal Cancer Prognosis and Prediction
Predictor C is a prognostic tissue test for UICC stage II / III colorectal cancer using Affymetrix technology to evaluate the expression of 30 genes that are involved in the disease's progression. Currently in the final stage of development, this profile is able to discriminate between high-risk patients and low-risk patients for more personalized clinical management.
Addressing an Unmet Need in the Management of Colorectal Cancer
Colorectal cancer (CRC) is the third most common cancer worldwide following lung and breast. In the five major European countries and the USA, approximately 400.000 individuals are diagnosed with CRC every year. Of these, 280.000 patients are diagnosed with stage II and stage III CRC. Approximately 30 percent of the patients with stage II and roughly 50 percent of those with stage III experience disease progression within three to five years after surgery. If the cancer spreads to distant organs, the five years survival rate is only 8 percent.
Current Guidelines show significant regional variations and do not recommend the routine use of adjuvant chemotherapy for patients with stage II colorectal cancer but some of them consider adjuvant treatment in the setting of high recurrence risk. Even though adjuvant treatment is recommended for all stage III CRC patients, just more than half of the patients receive adjuvant therapy. Presently, there are no validated clinical parameters or biomarkers in use to identify patients with a high-risk of disease progression. If this risk could be determined, a substantial number of patients with stage II / III disease would benefit from adjuvant chemotherapy in addition to surgery.
Predictor C Overview
During the last years many independent studies have shown that genomic profiling holds promise in predicting the long-term outcome of any one individual based on the gene expression profile of their cancer at diagnosis. Inherent to this approach is the hypothesis that every cancer contains informative gene expression signatures that, at the time of diagnosis, can portend the biologic behavior over time. The power of using microarray gene analysis for predicting the prognosis of stage II and III colorectal cancer patients has been demonstrated in several clinical studies, indicating the potential use of prognostic profiles for clinical management of colorectal cancer patients.
Signature Diagnostics AG has developed a multigene expression profile to predict progression of disease progression in UICC stage II and stage III colorectal cancer patients based on Affymetrix technology that will be helping physicians to make more personalized therapeutic recommendations for each individual.
Positive results from an international, prospective, multi-center performance evaluation study show the diagnostic ability of Predictor C to distinguish between high-risk and low-risk disease progression. Predictor C has been successfully validated using an independent set of frozen tumor tissue from 164 UICC stage II and III colorectal cancer patients. Within the five-year observation period, 72 patients experienced disease progression while no progression was seen in 92 patients. The performance evaluation study demonstrated a sensitivity (S+) of 64 percent; a specificity (S-) of 63 percent, a positive predictive value (PPV) of 58 percent and a negative predicted value (NPV) of 69 percent.
In particular, the PPV of 58 percent underpins Predictor C's clinical utility and justifies adjuvant treatment for high-risk patients. Predictor C identifies 51 percent of all stage II / III patients having a high-risk of disease progression.
Predictor C will offer Benefits for Patients and Health Care Professionals
Predictor C will have a significant impact on treatment of stage II and III colorectal cancer patients. This multi-gene test enables physicians to predict colorectal cancer progression and thereby provide their patients with a more specific treatment following surgery. The ability of this test to predict colorectal cancer progression fulfills a large unmet clinical need.
Predictor C is appropriate for persons who are newly diagnosed with stage II or stage III colorectal cancer and is performed on tumor tissue removed during the primary tumor surgery. Because of this, the Predictor C test does not require any additional surgery or procedures in order for a patient to get the test.
Predictor C will be commercially available in late Q4/2010 to early Q1/2011.