What do major guidelines say about the Oncotype DX® assay?
Oncotype DX is the only multigene breast cancer assay incorporated into 3 major clinical guidelines: those from the National Comprehensive Cancer Network® (NCCN®), the American Society of Clinical Oncology® (ASCO®), and the St Gallen Consensus guidelines. All 3 have included the Oncotype DX breast cancer assay in their guidelines as an option to predict whether certain patients will benefit from chemotherapy.
NCCN®
"On retrospective analysis of two trials (NSABP B-14 and B-20) performed in women with hormone receptor-positive, axillary lymph node-negative invasive breast cancer, this assay system was able to quantify risk of recurrence as a continuous variable (eg, Oncotype Dx recurrence score) and to predict responsiveness to both tamoxifen and CMF or methotrexate/5-fluorouracil/leucovorin chemotherapy."
NCCN Clinical Practice Guidelines in Oncology™: Breast Cancer (Version 2.2011) http://www.nccn.org (Accessed 9/29/2011).
ASCO®
The Oncotype DX assay may be used in newly diagnosed ER+, N- invasive 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;25:5287-5312.
To access these guidelines, click here.
St Gallen
The 12th St Gallen International Breast Cancer Conference (2011) Expert Panel distinguishes Oncotype DX as a multigene expression test that predicts chemotherapy benefit in patients with estrogen receptor-positive, HER2-negative invasive breast cancer. According to the current guidelines, although there are several tests that provide prognostic information, where uncertainty remains, only Oncotype DX is included as the multigene test that "may also be used where available to predict chemotherapy responsiveness" in estrogen receptor-positive breast cancer. The 51-member International St Gallen Expert Panel concluded that Oncotype DX results "may indicate a prognosis so good that the doctor and patient decide that chemotherapy is not required" in some patients.
NCCN is a registered trademark of the National Comprehensive Cancer Network; ASCO is a registered trademark of the American Society of Clinical Oncology. NCCN and ASCO do not endorse any therapy or product.