[Detection of tumor cells in bone marrow: a deciding aid for adjuvant therapy in node negative patients with breast cancer. Concept for a multicenter study and results of the pilot phase]

In node-negative breast cancer some 30% of patients will suffer a tumor relapse, despite primary curative therapeutic intervention. An adjuvant therapy is therefore in discussion, especially in presence of risk factors. Immunocytochemical staining of cytokeratin-positive cells in bone marrow aspirates with monoclonal antibodies offers a chance to detect tumorcell dissemination at an early stage of single tumor cells. In 103 consecutive patients 50% showed a positive bone marrow aspirate, in node negative patients still 34%. Based on the literature and tumor biology this method may be valid in selecting node-negative breast cancer patients for adjuvant therapy. In a prospective multi-center trial the prognostic value will be evaluated in regard to other prognostic factors. Additionally the benefit of an adjuvant therapy will be studied in a randomized prospective trial.