To assess the biological characteristics of transitional-cell carcinoma of the bladder (TCC), Stage T-1, which may be helpful in evaluating the appropriate treatment at this stage of disease, urine from 78 newly presenting patients who were candidates for transurethral resection (TUR) of tumors was analyzed cytologically and the number of tumors in each patient counted. In addition, the following biological characteristics of the resected tumors were examined: grade, cellular atypia, nuclear area, mitotic index, diploid fraction, S-phase fraction (percent), DNA index, and aneuploid fraction (number). The biological features were compared with the clinical status of patients. In 46 patients, the tumors were Stage pT(a) Grade 1-3; 19 were Stage pT(1) Grade 2-3, and 13 were Stage pT(2,3). The T-1 category of TCC appeared far more aggressive than T-a TCC after examining the various biological features, and when considering mitotic index and urine cytology, it was found to be more aggressive even in comparison with the T-2,T-3 category. The maximum mitotic index in the T-2,T-3 category was 19.2; in the T-1 category, 53% of the tumors had a higher mitotic index. The minimal mitotic index found in the T-1 category in our study was 4.07. There was no correlation between the number of tumors and the stage of the disease. Among the 15 patients at stage T-1 who were available for follow-up, in 8 patients, a mitotic index above 19.2 was found, and they were considered at high risk for progression. In this subgroup of patients, the time to first recurrence was significantly shorter than in the subgroup of T1 patients with a mitotic index below 19.2 (6.13 +/- 1.3 v 11.5 +/- 1.93 months). In the high-risk subgroup, two patients died of metastatic disease, whereas only one patient from the low-risk subgroup died, and that was of causes not related to carcinoma of the bladder. Biologically, TCC at Stage T-1 is far more aggressive than T-a TCC and cannot be classified as a superficial tumor. Tumors at Stage pT(1) with a mitotic index above 19.2 constitute a very malignant subgroup of T-1 tumors and may appropriately be treated by radical cystectomy after the first recurrence.