Short-schedule intravesical gemcitabine with ablative intent in recurrent Ta-T1, G1-G2, low- or intermediate-risk, transitional cell carcinoma of the bladder.

Primary Objective: to assess ablative efficacy and tolerability of short-schedule intravesical gemcitabine for intact, low- and intermediate-risk, recurrent superficial bladder tumours.

Secondary Objective: to assess effect on prophylaxis.

Methods: Patients with a diagnosis of recurrence and a history of previous superficial, low- or intermediate-risk bladder tumours were selected for the study. They received 2000 mg gemcitabine in 50 ml, that is 40 mg/ml, intravesically, weekly for 4 wk, followed by resection of any residual lesions. Complete responses consisted of absence of any macroscopic, histologically confirmed, residual lesion, and no response in the presence of residual lesions. The effect on prophylaxis was measured in months as disease-free interval to first recurrence, and as percentage of patients recurring within the first 12 mo. Toxicity was assessed as local and systemic.

Results: Of 34 recruited patients, 28 consecutive patients were evaluable, with complete responses observed in 13 of 28 (46.4%) and no response in 15 (53.6%). Median time to first recurrence was 9.1 mo (range: 2.9-26.5) for 19 of 28 (67.8%) patients experiencing recurrence during the first year. Local or systemic toxicity was observed in 9 of 34 (26.4%) patients, resulting in protocol interruption in 6 patients.

Conclusions: Intravesical gemcitabine alone showed ablative efficacy in nearly one half of the patients under study. Drug tolerability was good, both locally and systemically.