Does the use of Oncotype DX tumor gene expression profiling to guide treatment decisions improve outcomes in patients with breast cancer?

The expression of specific genes within breast tumor cells has been found to be associated with the chance of disease recurrence. Several gene expression profiles (GEP) are clinically available that provide variations on “recurrence risk scores” intended to help doctors and their patients in treatment decision-making. Determination of breast cancer GEP recurrence risk scores has been proposed as a means to identify those women most likely to benefit from chemotherapy.

EGAPP Recommendation Statement: The EGAPP Working Group found insufficient evidence to recommend for or against the use of Oncotype DX testing to guide chemotherapy treatment decisions in women with hormone receptor-positive, lymph node-negative, or lymph node-positive early breast cancer who are receiving endocrine therapy. This recommendation statement updates a 2009 EGAPP statement on the use of gene expression profiling tests in breast cancer. Evidence of clinical validity for Oncotype DX was confirmed as adequate. With regard to clinical utility, although there was evidence from prospective retrospective studies that the Oncotype DX test predicts benefit from chemotherapy, and there was adequate evidence that the use of Oncotype DX gene expression profiling in clinical practice changes treatment decisions regarding chemotherapy, no direct evidence was found that the use of Oncotype DX testing leads to improved clinical outcomes.

EGAPP Recommendation (December 2015)

Evidence Report (December 2014)

Why EGAPP Selected this Topic for Review:

Key Criteria: Prevalence and severity of breast cancer; relevance to healthcare providers and patients for decision-making.

Other Considerations: EGAPP methods challenged by limited literature and assessment of the grey literature; potential impact on women with breast cancer.