Gemcitabine in intravesical treatment of Ta-T1 transitional cell carcinoma of bladder: Phase I-II study on marker lesions.

OBJECTIVES: To study the ablative activity of intravesical gemcitabine against superficial transitional cell carcinoma of the bladder at different doses and concentrations.

METHODS: A total of 27 patients were treated with intravesical gemcitabine after transurethral resection during which one to three papillary marker lesions were left unresected. Starting 14 days after transurethral resection, six instillations of gemcitabine were given at weekly intervals. Gemcitabine, diluted in 50 mL of saline solution and maintained for 2 hours, was given at the dose of 500 mg, 1000 mg, and 2000 mg in groups of 9 patients each. A complete response (CR) was defined as negative cytology, cystoscopy, and biopsy findings. Patients achieving a CR received monthly maintenance for up to 1 year and underwent cytology and cystoscopy at 3-month intervals.

RESULTS: Of the 27 patients, 1 was lost to follow-up, and of the remaining 26 patients, 6 (23%) achieved a CR. A CR was achieved in 1 patient (12.5%), 2 patients (22.2%), and 3 patients (33.3%) at a dose of 500, 1000, and 2000 mg, respectively. A partial response was obtained in 2 additional patients (22%) at a dose of 500 and 1000 mg. Bladder Tis was diagnosed in 2 patients with a CR at 3 and 8 months after treatment. The remaining 4 patients were disease free at a follow-up of up to 22 months. Systemic and local tolerability was excellent, and no treatment interruption was required.

CONCLUSIONS: Our experience has shown the good tolerability and potential efficacy of intravesical gemcitabine against recurrent transitional cell carcinoma of the bladder. Gemcitabine might be proposed, if our results are confirmed by larger studies, as a second-line therapy in patients who cannot tolerate more aggressive intravesical therapy.