What do major guidelines say about the Oncotype DX® assay?

Both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) have included the Oncotype DX assay in their guidelines as an option to predict whether certain patients will benefit from chemotherapy.

ASCO

The Oncotype DX assay is recommended for use in newly diagnosed ER+, N- breast cancer patients to predict risk of recurrence. The assay can also be used to identify patients who may be successfully treated with tamoxifen and may not require adjuvant chemotherapy. “It has been suggested that tamoxifen-treated patients with an excellent estimated prognosis may be spared adjuvant chemotherapy.”

Harris L, Fritsche H, Mennel R, et al. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol. 2007;25(33):5287-312.

To access these guidelines, click here.

NCCN

“The option of using a gene-based assay of tumor tissue (Oncotype DX, Genomic Health) to help guide chemotherapy treatment decisions is now included within the systemic adjuvant treatment decision pathway for patients with node-negative or pN1mi (micrometastasis: 0.2 mm - 2.0 mm), hormone-receptor-positive, HER2-negative tumors that are 0.6 to 1.0 cm and moderately/poorly differentiated or with unfavorable features or > 1 cm.”

NCCN Clinical Practice Guidelines in Oncology™ Breast Cancer, (Version 2.2008) http://www.nccn.org (Accessed 1/9/08).