ASCO adds Oncotype DX to marker guideline

ALEXANDRIA, Virginia—ASCO has added the Oncotype DX gene expression assay to its updated guideline for the use of tumor markers in breast cancer (J Clin Oncol November 20, 2007). ASCO evaluated but did not recommend four other new markers for breast cancer: cyclin E, proteomic analysis, bone marrow micrometastases, and circulating tumor cells. Previously recommended tests include CA 15-3, CA 27.29, CEA, ER/PR, and HER2.

The Oncotype DX tumor marker test is recommended for patients with newly diagnosed node-negative breast cancer that is ER-positive and/or PR-positive. The test measures multiple genes at once to estimate the risk of breast cancer recurrence. Patients with a low recurrence score may be able to receive only hormone therapy and avoid chemotherapy. Other gene assays under investigation but not yet recommended include MammaPrint, the Rotterdam Signature, and the Breast Cancer Gene Expression Ratio.

Also newly recommended for estimating a node-negative patient's prognosis are urokinase plasminogen activator (uPA) and plasminogen activator inhibitor (PAI-1). Patients with tumors that do not have uPA and PAI-1 have a good prognosis and may not need chemotherapy. However, the test is not currently commercially available in the US.