Systematic review on hormone receptor testing in breast cancer.

Assessment of hormone receptors (estrogen and progesterone) helps to direct therapy for women with breast cancer. Immunohistochemistry is most commonly used to assess hormone receptor status and it is essential that these tests are performed accurately and reliably within and across laboratories. The overall purpose of this guideline is to improve the quality and accuracy of hormone receptor testing and its utility as a prognostic and predictive marker for invasive and in situ breast cancer. Medline, EMBASE, the Cochrane Database of Systematic Reviews, and abstracts from the San Antonio Breast Cancer Symposium were searched. An environmental scan of the internet and of international guideline developers and key organizations was performed. Preanalytic elements such as the collection, fixation, and storage of samples, and analytic elements such as selection of antibodies and scoring methods that seem to offer the best results for immunohistochemical assessment of hormone receptors are presented. Proficiency testing or quality assurance of immunohistochemistry is described.