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Introduction: Cytokeratin fragment 21.1 (CYFRA 21.1) assay detects a serum fragment of cytokeratin 19 (CK19) and is employed in the diagnosis and management of lung cancer, particularly of squamous cell histotype. Breast carcinoma has been demonstrated to express CK19 fragments in the primary and metastatic lesions and CK19 mRNA is detectable in peripheral blood from patients affected by breast cancer. Aim of the work: The aim of the present study was to evaluate the clinical significance of serum CYFRA21-1 in patients with breast cancer by analyzing the correlation between serum CYFRA21-1 titers, clinicopathological factors and prognosis in comparison with serum CA15.3 and CEA tested in the same samples. Subjects and methods: This study included 60 breast cancer patients and 25 healthy females as control group. Three blood samples were drawn from each patient, before surgery, two weeks after surgery and after 6 cycles of chemotherapy. One blood sample was drawn from each subject of control group. Serum was separated and kept frozen till used for estimation of CYFRA21-1 by enzyme linked immunosorbent assay (ELISA) and serum CA15.3 and CEA by immunoradiometric assay (IRMA). Results: Serum CYFRA21-1 was highly elevated in breast cancer patients than in controls and was significantly associated with tumor size, clinical stage and axillary lymph node involvement. Serum CYFRA21-1 was superior to CA15.3 and CEA as a diagnostic marker for breast cancer using ROC curve analysis. Higher levels of serum CYFRA21-1 and CA15.3 were significantly associated with poor prognosis in primary breast cancer patients. Conclusions: The measurement of serum CYFRA 21-1 in breast cancer patients may be useful for detecting disease relapse and for assessing surgical and chemotherapeutic efficacy. Further prospective studies using greater number of patients are required to confirm our findings.

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