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PubMed1996

Chemoresection in Ta-T1 bladder cancer. Members of the EORTC Genito-Urinary Group.

OBJECTIVES: The authors present the results of two parallel phase II trials, instituted by the EORTC Genito-Urinary Group in 1986, whose aims were to assess the tolerability and ablative capacity of mitomycin C (study 30864) and epirubicin (study 30869) in patients with multiple primary or recurrent Ta-T1 bladder cancer. METHODS: A well-defined tumour (marker lesion) was left in the bladder after transurethral resection (TUR). All patients received 8 weekly instillations, after which cystoscopy with bladder biopsies +/- TUR was performed. Responses were rated as follows: (1) complete-no visible or microscopic bladder cancer; (2) no change-persistence of the marker lesion; (3) progression-increased marker lesion size, new tumour(s) or presence of muscle-invasive disease at any site. RESULTS: Ninety-six evaluable patients were treated with mitomycin and 36 with epirubicin. The overall bladder response in the former group was complete in 50%, no change in 30% and progression in 20% of patients, while the marker lesion response was complete in 57%, no change in 39% and progression in 4%. In the epirubicin group, 56% of the patients achieved a complete overall response, while there was no change in 22% and progression in 22%. The marker lesion response in this group was complete in 67%, no change in 31% and progression in 3%. Only 2 cases of progression were due to the presence of muscle-invasive disease. Both of these were in the mitomycin group; 1 was at the marker lesion site, and 1 was at a remote site. CONCLUSIONS: The present studies confirm the feasibility and safety of the marker lesion model for the objective evaluation of the antitumoural activity of intravesically administered drugs.

Administration, Intravesical↗
PubMed1997

Bladder tissue pharmacokinetics of intravesical taxol.

Our previous studies have suggested that the ineffectiveness of intravesical mitomycin C or doxorubicin therapy against muscle-invading bladder cancer is in part because of the inability of these drugs to penetrate the urothelium (the urothelial drug concentration is < 5% of the concentration in urine). The goal of the present study was to identify agents that are efficiently absorbed across the urothelium. To evaluate the potential use of taxol in intravesical therapy for bladder cancer, we examined the bladder tissue and systemic plasma pharmacokinetics of intravesical taxol in dogs. Animals (approximately 8 kg body weight) were given an instillation of taxol at 500 micrograms in 20 ml water. At 120 min postinstillation, the bladder was emptied and excised, and about 85% of the dose was recovered in the urine. The taxol concentration in the urothelium was about 50% of the concentration in the urine, the concentrations then declined logarithmically in the underlying capillary-perfused tissues. The average tissue concentration (-2 micrograms/g) was two to three times the reported plasma concentration of 0.75 microgram/ml in patients following intravenous infusion of the > 100-fold higher dose of 250 mg/m2. The steady-state plasma concentration was < 0.02% of the average tissue concentration, and was < 0.05% of the maximally tolerated plasma concentration in patients. The octanol:water partitioning coefficients of taxol, doxorubicin, and mitomycin were > 99, 0.52, and 0.41, which parallels the rank order of the partitioning across urothelium, i.e. taxol (approximately 50%) > > doxorubicin approximately mitomycin C (-3%). In summary, the partitioning of taxol across the urothelium was more favorable than the partitioning of mitomycin C and doxorubicin, and the systemic concentration of taxol resulting from intravesical treatment was insignificant in spite of the extensive absorption into the bladder. We conclude that intravesical delivery of taxol provides a significant bladder tissue targeting advantage, and that taxol represents a viable candidate drug for intravesical bladder cancer therapy.

Administration, Intravesical↗
PubMed1992

Complications of intravesical bacillus Calmette-Guerin: a case report.

Bacillus Calmette-Guerin (BCG) is the most effective agent currently available to treat superficial bladder cancer. However, this form of therapy is not without potential serious or fatal complications. In addition to the potentially toxic systemic side effects attributed to hematogenous absorption of the bacillus, direct upper tract seeding may occur in patients with vesicoureteral reflux. We report on a patient treated with intravesical BCG for bladder cancer in whom unilateral necrotizing granulomatous pyelonephritis developed. Although severe, this complication is rare and we conclude that reflux is not a contraindication for intravesical BCG therapy.

Administration, Intravesical↗
PubMed1996

[Mitomycin-C 30 mg for 12 months versus Mitomycin-C 40 mg for 6 months in the prevention of superficial bladder carcinoma G1-G2].

A total of 60 patients with transitional cell carcinoma of the bladder G1-G2, pTa pT1 previously subjected to TUR, were randomised to receive Mitomycin-C (MMC) 30 mg for 12 months (A group) or Mitomycin-C 40 mg for 6 months (B group). The objective of this trial was to compare the prophylactic activity of MMC using two different dosages and treatments. All patients were evaluated with cystoscopy. Follow-up was of 24 months. The incidence of recurrence in the A group was 40% with a recurrence rate of 3.3. In the B group the incidence of recurrence was 27.6% with a recurrence rate of 2.2. One case of progression was present in the A group. The side effects were more frequent in the A group (37% vs 13.3%) and they were mainly due to chemocystitis. These data suggest that MMC 40 mg for 6 months appears to be superior to MMC 30 mg for 12 months in the prophylaxis of superficial bladder carcinoma.

Administration, Intravesical↗