Abstract
Two separate uses of intravesical therapy with thio-tepa were tested: 1) the ablative effect on noninvasive carcinoma of the bladder (that is treatment) and 2) the prophylactic effect in the prevention of new or recurrent tumors (that is prophylaxis).Of the 95 patients treated with thio-tepa for the ablation of incompletely resected carcinoma of the bladder (stages O and A) 45 (47 per cent) were free of disease after 2 treatment courses. The success rate was not affected by the dose (30 or 60mg.) or by pathologic assessment of stage and grade. The number of tumors was associated with response to treatment. Patients with 4 or more tumors did not do as well as patients with less than 4 (success rates of 36 and 62 per cent, respectively, which is significant statistically, p equals 0.02).The prophylaxis study included 93 patients: 23 on 30mg. dose, 23 on 60mg. and 47 controls. The interval free of disease was longer for patients receiving thio-tepa prophylaxis compared to the controls (statistically significant difference). The results with the 30 and 60mg. regimens were similar.The interval free of disease in the prophylaxis group appeared to be influenced by the presence or absence of cancer cells in the cytology specimens obtained before randomization. Although the difference was not statistically significant for these patients the time to disease recurrence was longer for the patients with negative cytology reports compared to patients with positive (cancer cells present) cytology reports.Patients who had been treated successfully with thio-tepa for incompletely resected tumor did well on the prophylaxis regimen (100 per cent were free of disease at 12 months). Of particular interest is the relatively favorable interval free of disease for patients who were treated successfully with thio-tepa for ablation of incompletely resected tumor but did not receive thio-tepa prophylaxis (that is randomized to the control group). In this group 60 per cent of the patients were free of disease at 12 months.
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