Low utility of CYFRA 21-1 serum levels for diagnosis and follow-up in bladder cancer patients.

We evaluated serum levels of soluble fragments of cytokeratin 19 (CYFRA 21-1) by immunoassay (ES-700; Roche Diagnostics, Mannheim, Germany) to assess its usefulness in the diagnosis and follow-up of bladder cancer. The study included 39 patients with a diagnosis of transitional cell carcinoma (group 1) and 190 patients (group 2) with no evidence of tumor. In group 2, 180 patients had a history of bladder cancer, and 10 had benign prostatic hyperplasia. Significant differences in CYFRA 21-1 concentrations between groups 1 and 2 (P<0.01) were noted. However, CYFRA 21-1 levels did not significantly differ between the patients with benign prostatic hyperplasia and those with bladder cancer (P=0.274). CYFRA 21-1 values were higher in invasive bladder cancer compared to that detected in superficial stages (P=0.011). Setting the optimal cutoff value at 2.5 ng/mL resulted in a sensitivity of 43.6% and a specificity of 82.1%. No statistical differences were found when we compared disease-free time among the 66 patients with recurrences (30.7 months with levels <2.5 ng/mL vs. 41.2 months with levels >2.5 ng/mL; P=0.248). The risk of recurrence in patients with levels lower than 2.5 ng/mL (0.79) was no different (P=0.097) from that found in patients with higher levels (1.69). CYFRA 21-1 serum levels do not provide enough sensitivity to justify its application in routine protocols for the detection and follow-up of bladder cancer.