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RESEARCH PRODUCT

Results of a Phase I-II Pilot Study with Intravescical Gemcitabine in Superficial Bladder Cancer (Ta-T1)

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To study the ablative activity of intravescical gemcitabine against superficial transitional cell carcinoma of the bladder at different doses and concentrations. Methods Twenty-seven patients were treated with intravescical gemcitabine after transurethral resection, during which one to three papillary marker lesions were left unresected. Starting 14 days after transurethral resection, six gemcitabine instillations were given at weekly intervals. Gemcitabine, diluted in 50 mL of saline solution and maintained for 2 hr, was given at a dose of 500, 1000 and 2000 mg in groups of nine patients each. A complete response (CR) was defined as negative cutologycystoscopy and biopsy findings. Results Of the 27 patients, one was lost to follow-up, and of the remaining 26 patients, six (23%) achieved a CR. A CR was achieved in one patient (12.5%), in two patients (22.2%) and in three patients (33.3%) at dose of 500, 1000 and 2000 mg, respectively. A partial response was obtained in two additional patients (22%) at a dose of 500 and 1000 mg. Bladder Tis was diagnosed in two patients with a CR at 8 and 3 months, respectively. Systemic and local tolerability was excellent, and the interruption of treatment was not required. Conclusions Our experience has shown the good tolerability and the potential efficacy of intravescical gemcitabine against recurrent transitional cell carcinoma of the bladder. Gemcitabine could be proposed, if our results are confirmed by larger studies, as a second-line therapy in patients who cannot tolerate more aggressive intravescical therapy.