Evaluation of urinary bladder cancer antigen as a marker for diagnosis of transitional cell carcinoma of the urinary bladder

The purpose of the present study was to assess a new quantitative urinary t umor marker for transitional cell carcinoma of the urinary bladder (TCC), m easuring fragments of cytokeratin 8 and 18 in the urine (UBCB(TM)). Urine s amples of 355 individuals (77 healthy volunteers, III patients with benign urologic disorders, 167 patients with histologically proven bladder cancer) were examined for the presence of UBC antigen. Samples of all patients wer e obtained prior to therapy. Compared to healthy volunteers or patients wit h benign urologic disease, patients with TCC had significantly higher media n urinary levels of UBC antigen (0 vs. 4.18 vs. 7.46 mu g/g creatinine; p<0 .001, and p<0.01, respectively). UBC antigen levels were positively correla ted with tumor grade and stage. Patients with invasive TCC had significantl y higher levels of UBC antigen than patients with superficial TCC (p<0.001) . Elevated levers of UBC antigen were also found in patients with benign ur ologic disorders (median: 4.18 mu g/g creatinine vs. 7.46 mu g/g creatinine in cancer patients). Using a cutoff of 14.06 mu g/g creatinine (correspond ing to 95% specificity in the group of healthy individuals), sensitivity of UBC antigen ranged between 21.6% (pTa) and 75% (pT4). Overall specificity was 76.6%. Based on our data we conclude that the UBC antigen test in its c urrent format is not clinically useful for detection of bladder cancer.