Superficial bladder cancer: the response of a marker tumour to a single intravesical instillation of epirubicin.

OBJECTIVE: To determine the response of a marker tumour to a single instillation of intravesical epirubicin. PATIENTS AND METHODS: Eighty-one patients (54 men, 27 women) with a mean age of 69.3 years (range 36-92) with superficial bladder cancer were randomized to receive a single instillation of intravesical epirubicin. At the initial cystoscopy all but one papillary marker tumour was resected. Subsequently the patients were randomized to receive either intravesical epirubicin at a concentration of 1 mg/ml (n = 40) or 2 mg/ml (n = 41) in 50 ml of saline for 1 h. The response of the marker tumour was determined at 3 months (first check cystoscopy). The toxicity associated with both treatments was also recorded.
RESULTS: A complete response (no visible or microscopic bladder carcinoma) was observed in 46% (95% confidence interval (CI) 35-57%) of patients. No patient experienced systemic side-effects. Chemical cystitis and bladder irritability were the most frequent local side-effects, occurring in 15% (95% CI 8-24%) of the patients.
CONCLUSIONS: A single instillation of intravesical epirubicin has a demonstrable effect in superficial bladder cancer. The results compare favourably with more onerous regimes. Side-effects were minimal at 1 mg/ml and acceptable at 2 mg/ml.

RCT Entities:   Population Interventions Outcomes