Future Clinical Potential

Consensus is now obtained regarding quality control issues and criteria for acceptable technical assay performance in order to permit multicenter clinical studies (11). With these developments, the final step toward implementation into the clinical setting will be taken. In addition to standardization of technical issues, more detailed marker implement-tation into current risk classification systems, such as the Tumor-Node-Metastasis (TNM) Classification System, is needed.

BM and blood can be obtained repeatedly in the postoperative course of treatment. Therapeutic efficacy of adjuvant systemic therapy can be assessed currently only retrospectively in large-scale clinical trials following a long observation period. The potential of a surrogate marker assay that permits immediate assessment of therapy-induced effects is therefore evident. For example, it could be possible to identify patients who need additional adjuvant therapy, e.g., bisphosphonate treatment which might be able to eliminate tumor cells in bone marrow persisting after adjuvant treatment. Prospective clinical studies must evaluate whether eradication of DTC in BM and blood after systemic therapy translates into a longer disease-free period and overall survival. An additional important goal is the possibility of identifying tumor specific targets to improve therapy regimens. Studies have shown that it is possible to identify therapeutic targets on DTC and some evidence suggests that single DTC show different properties than cells of the primary tumor (35, 36, 54). This is of importance, e.g., in the context of new therapeutic approaches, like antibody treatment directed against HER-2/neu which has been demonstrated to reduce relapse rates in the adjuvant setting.

In addition, the research in the field of tumor cell dissemination should lead to an increased understanding of the metastatic cascade. This could allow the development of new therapeutic approaches suppressing the development of metastatic disease when applied in the early stage of micrometastases before the development of manifest metastatic disease.

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