Initial evaluation of CYFRA 21-1 diagnostic performances as a urinary marker in bladder transitional cell carcinoma

Purpose: CYFRA 21-1, an immunoradiometric assay developed for the detection of a soluble cytokeratin 19 fragment, is evaluated for its diagnostic performance in urine of patients with transitional cell carcinoma. Materials and Methods: CYFRA 21-1 was investigated in serum and urine of 128 patients, including 48 with bladder transitional cell carcinoma (group 1), 44 with other urological pathological conditions (group 2) and 36 free of urothelial disease (group 3). Urinary cytopathology was also performed. Results: Mean urinary CYFRA was 123.5 +/- 53, 11.9 +/- 4.8 and 2.3 +/- 0.2 ng./ml. for groups 1 to 3, respectively, and was significantly different. From the receiver operating characteristics curve, the optimal combination of 96% sensitivity and 74% specificity was determined for a threshold value of 4 ng./ml. while overall cytopathology sensitivity was 43%. Conclusions: Urinary CYFRA 21-1 may be a useful marker for diagnosing transitional cell carcinoma.