Clinical relevance of CYFRA 21-1, TPA-IRMA and TPA-LIA-mat in urinary bladder cancer.

The sera of 154 cancer patients were analyzed at primary diagnosis before any therapy to find out the clinical importance of CYFRA 21-1 (detecting cytokeratin 19-fragments) compared with the polyclonal TPA-IRMA and the monoclonal TPA-LIA-mat-assay (both measuring fragments of cytokeratin 8, 18 and 19). The reference group consisted of 100 healthy persons as well as 78 patients with exclusively benign urological diseases. We defined the cut-off values based on 95% specificity versus benign urological disorders. For CYFRA 21-1 the cut-off value was found to be 2.5 ng/ml, for TPA-IRMA 165 U/L, and for TPA-LIA-mat 136 U/L. Taking into account all stages CYFRA 21-1 showed a sensitivity of 31% versus 20% and 16% for TPA-IRMA and TPA-LIA-mat, respectively. Considering only the muscle invasive carcinomas 52% sensitivity for CYFRA 21-1 vs. 39% and 33% for TPA-IRMA and TPA-LIA-mat could be found. All three markers correlate with the stage of disease, CYFRA 21-1 to the highest degree (stage O: 16%, stage IV: 71%). CYFRA 21-1 shows the best sensitivity-specificity-profile and seems to be a recommendable marker for the follow-up of urinary bladder cancers except for the Ta-tumors which only rarely develop into muscle invasive cancers.