On April 14th, Genomic Health announced that the QUASAR validation study of its colon cancer test met its primary endpoint of predicting the likelihood of cancer recurrence for stage II colon cancer patients following surgery. Also,
the colon cancer Recurrence Score® provided additional independent clinical value beyond standard measures of risk for this patient population.
Based on these positive results, we are currently initiating the necessary work in our Clinical Reference Laboratory and proceeding with commercialization plans, in order to make the Oncotype DX colon cancer Recurrence Score available to doctors and patients in early 2010.
We also reported that the study did not meet a secondary endpoint for predicting which patients experience a greater relative benefit of 5-FU/LV chemotherapy following surgery. Although the specific treatment genes did not achieve this clinical hurdle, this study represents a key milestone for the tens of thousands of stage II colon cancer patients who will benefit from a more accurate assessment of individual risk.
To develop this test, we used the same rigorous clinical development strategy and standardized quantitative assay technology that we used when designing the Oncotype DX breast cancer test. We partnered with the National Surgical Breast & Bowel Project (NSABP) and the Cleveland Clinic Foundation to evaluate the tumor samples for 761 candidate genes from more than 1,800 colon cancer patients, which led to the selection of the final genes for the Oncotype DX colon cancer test. These resulting genes were then studied independently in more than 1,200 stage II colon cancer tumor samples from the landmark QUASAR study (Lancet 370:2020, 2007).
Genomic Health’s goal has always been to improve the quality of treatment decisions for patients with cancer. We are pleased to confirm that, through our discussions with several medical advisors and leading clinicians, the prognostic information yielded from this test will be significant in guiding doctors and patients in making personalized treatment decisions.
In fact, the oncology medical community widely recognizes the need for better prognostic tools in stage II colon cancer (also known as Dukes' Stage B) that can more accurately predict the likelihood of disease recurrence. Currently, approximately 30-40,000 people each year in the United States are diagnosed with stage II colon cancer, and the decision about which stage II patients should undergo chemotherapy following their surgery relies on a limited set of clinical and pathologic markers. Unfortunately, these markers do not always adequately assess an individual patient’s risk of experiencing a future disease recurrence. As a result, determining the optimal treatment of stage II colon cancer patients is a significant challenge for many physicians in clinical practice.
Therefore, we believe that the positive findings of this large QUASAR validation study represent a significant step forward in better understanding the biology of colon cancer, a disease that is a leading cause of cancer-related death.
With these results, we believe we can introduce the promise of genomics into clinical practice for colon cancer as we did in breast cancer. For those who are interested in learning more, detailed results from the QUASAR study are scheduled to be presented during the upcoming American Society of Clinical Oncology meeting in Orlando, Florida.