Pilot study of the tolerability and toxicity of intravesical valrubicin immediately after transurethral resection of superficial bladder cancer

Objectives. To assess in a pilot study the safety, tolerability, and techni cal feasibility of administering intravesical valrubicin immediately after transurethral resection of bladder tumors (TURBT) in patients with superfic ial bladder cancer and to evaluate the optimal dose of valrubicin and its s ystemic absorption. Methods. Twenty-two patients with recurrent or newly diagnosed Stage Ta or T1 transitional cell tumors received a single dose of 400 mg, 600 mg, or 80 0 mg of intravesical valrubicin immediately after TURBT, Four patients thou ght to be at high risk of recurrence were followed up with five additional doses of 800 mg valrubicin, given weekly. Results. The use of valrubicin after TURBT was generally well tolerated, Li ttle evidence was found to suggest a direct relationship among the dose of valrubicin, the time between the end of TURBT and drug instillation, and th e occurrence of most bladder symptoms. The most commonly reported adverse e vents included dysuria (77%), hematuria (59%), and urgency/frequency (23%), Pharmacokinetic analyses revealed that the mean systemic exposure to valru bicin and its metabolites depended on the extent of the TURBT and the damag e to the bladder wall. Conclusions. The results of this study indicated that administration of val rubicin immediately after TURBT is feasible. UROLOGY 56: 232-235, 2000. (C) 2000, Elsevier Science Inc.