Intravesical gemcitabine in recurrent superficial bladder carcinoma: preliminary results on ablative efficacy and tolerability.

Background: The ablative potential and toxicity of gemcitabine, administered intravesically in low stage and grade superficial transitional cell carcinoma (TCC), were evaluated.
Patients and Methods: Patients with a history of recurrent Ta-T1, GI-G2 bladder TCC were considered eligible for the study. Gemcitabine was administered intravesically at 40 mg/mL concentration (2000 mg in 50 ml saline) in one weekly instillation for 4 consecutive weeks. Fifteen days after the last instillation, patients were submitted to transurethral resection (TUR).
Results: Twenty-six patients were evaluable for toxicity, and 20 were evaluable for response, 6 patients being excluded due to toxicity. A complete response was achieved by 10 out of 20 patients (50%), whereas no response was documented in the remainder. Toxicity leading to treatment interruption was grade 3 in 1 patient and grade 2 in 5 patients.
Conclusion: Intravesical gemcitabine administered at 40 mg/mL showed the capability of ablating small volume, superficial TCC in 50% of the population under study, with acceptable tolerability.