Genomic Health Announces Positive Topline Results of Second Large, Independent Validation Study of Oncotype in DCIS Breast Cancer
GHDX) today announced positive preliminary results from a second large, independent clinical validation study of Oncotype DX in patients with a pre-invasive form of breast cancer, also known as DCIS (ductal carcinoma in situ).Â The study, conducted by the Ontario DCIS Study Group in Canada, met its primary endpoint by demonstrating that the Oncotype DX DCIS Scoreâ„¢ predicts the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast.
Representing the largest genomic study in DCIS to date, these results confirm and extend the conclusions of the previously published validation study performed by the ECOG-ACRIN Cancer Research Group.Â Additionally, for the first time, the Oncotype DX DCIS Score predicted the risk of local recurrence in a group of patients treated with radiation therapy in clinical practice. Genomic Health and the Ontario DCIS Study Group are submitting the results from this study for presentation at the 2014 San Antonio Breast Cancer Symposium in December.
"It is widely recognized that a large proportion of women with DCIS are treated with a limited ability to quantify risk associated with the patient's underlying tumor biology," said Eileen Rakovitch, M.D., radiation oncologist and principal investigator, Sunnybrook Health Sciences Centre, Canada.Â "Our landmark study, analyzing an unprecedented collection of DCIS tissue samples representative of a contemporary patient population, confirms that the Oncotype DX test can help individualize treatment decisions for this pre-invasive type of breast cancer.