Information for Managed Care Professionals
The Oncotype DX® Breast Cancer Assay provides personalized information based on tumor biology that can inform treatment decisions that are cost effective for members.
Early Stage Invasive Breast Cancer
The Oncotype DX® Breast Cancer Assay is clinically validated to predict the risk of recurrence for those women with early stage (I, II, IIIa) invasive breast cancer that are estrogen-receptor positive (ER+), human epidermal growth factor receptor negative (Her2-), lymph node negative or positive, and predict who may or may not significantly benefit from adjuvant chemotherapy. The assay validation is supported by Level Ib evidence based on the assay development criteria described in the Journal of the National Cancer Institute (JNCI) in 20091. A recently published meta-analysis of 912 patients from seven independent studies demonstrates the clinical utility2. In addition, the Oncotype DX Breast Cancer Assay is incorporated in the clinical guidelines of the American Society of Clinical Oncology® (ASCO®),l St. Gallens, and the National Comprehensive Cancer Network® (NCCN®)3. The health economic implications for improving the quality and outcome of early stage breast cancer decision may impact commercial health plans, the Centers for Medicare Services (CMS), and the oncology community as a whole.
Now Validated in Ductal Carcinoma in Situ (DCIS)
The Oncotype DX Breast Cancer Assay for DCIS Patients is now validated for use. The DCIS Score™ algorithm calculation was validated from a large, independent, multi-center trial (ECOG 5194) by Solin et al. To better inform treatment decisions in DCIS, the assay can:
- Predict baseline risk of local recurrence of DCIS or invasive carcinoma after surgical excision of DCIS tumor;
- Predict baseline risk of local invasive recurrence after surgical excision of DCIS tumor;
- Help to identify which patients have a lower risk of recurrence, and therefore may decide to forego more aggressive treatment, knowing the risk/benefit and short/long term toxicities and costs of such treatment.
It is the first validated commercial genomic assay that provides additional information beyond traditional clinicopathologic measures for quantitatively predicting recurrence risk in DCIS patients. The results of this study were first presented at the San Antonio Breast Conference in 2011.
In this portion of the Oncotype DX website, abbreviated sections are provided from the recently developed Genomic Health Oncotype DX Assay Genomic Dossier for managed care, health technology assessment and government affairs professionals. A complete section is available by clicking an attached PDF.