Intravesical chemotherapy with epirubicin: A dose response study

Purpose: We determined the difference in response to high and standard dose s of intravesical epirubicin for treatment of superficial bladder cancer. Materials and Methods: A total of 122 patients were entered into a randomiz ed trial to compare the response of a marker tumor at 3 months, time to fir st recurrence and recurrence rates for 2 years after intravesical chemother apy for superficial (pTa/pT1) bladder cancer. Patients were randomized to r eceive treatment for 1 hour with 1 (standard dose) or 2 mg./ml. (high dose) epirubicin (50 or 100 mg./50 mi. solution). Results: There was no difference in the marker tumor response rate in 24 of 52 patients treated with the standard dose compared with 21 of 50 treated with the higher dose of epirubicin (p = 0.67). Similarly, the higher dose w as not superior in regard to time to first recurrence, with a hazard ratio of 1.46 (p = 0.14, 95% confidence intervals 0.88 to 2.42). Considering the upper end of the confidence interval, we can reliably exclude an absolute d ifference of greater than 4% at 1 year for time to first recurrence in favo r of higher dose chemotherapy. Conclusions: Epirubicin at double the standard dose for intravesical chemot herapy of superficial bladder cancer is not superior in regard to marker tu mor response, time to first recurrence or recurrence rate.