Intravesical gemcitabine in superficial bladder tumours preliminary results of a phase I-II study

Vincenzo Serretta, Marco Vella, Carlo Pavone, Antonio Lupo, Maria Lucia Tarantino, Michele Pavone

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INTRODUCTION & OBJECTIVES: Gemcttabme is a pro-drug requmng intracellularphosphorylation by deoxycytidine kinase to be activated. Preliminary experiences.suggesting the activtty and the good tolerability of the drug on superficial transitional cellcarcinoma of the bladder (TCCB) when administered by intravesical route, have beenrecently published. The mm of the present study was to evaluate the ablative efftcacy ofweekly intravesical instillations of gemcitabine against paptllary marker lesions left afterTUR of superficial TCCB. The scientific background and the ethical acceptability of thtsapproach have been balidated by the European Organization for Research and Treatment otCancer Urological Group.MATERIAL & METHODS: Twelve patients. affected by recurrent multiple superficialTCCB (Ta-Tl, Gl-G2), were treated with intravesical gematabine after a transurethralresection (TUR) during which 1 to 3 papillary marker lesions (5-15 mm in diameter) wereleft unresected. High-grade (G3) tumours and Tis were excluded. Nine patients have beenpreviously treated with mtravesical chemotherapy. Starting I4 days after TUR, 6instillations of gemcitabine were given at weekly intervals. Gemcitabine, diluted in 50 cc ofsaline solution and maintained in the bladder for two hours, was given at the dose of 500mg, 1000 my and 2000 mg in 4. 5, and 4 patients respectively. The patients, 14-21 days afterthe last instillation. were submitted to cytology. cystoscopq and TUR or cold cup biopsy ofevery suspicious lesion and at the sites ofthe marker tomours. Complete response (CR) wa\defined as negative cytology, cystoscopy and biopsy. Partial response (PR) was defined asa reduction in number of multiple lesions. Local and systemic toxicity was investigated atweekly intervals. Routine laboratory tests were carried out every 4 weeks. Patientsachieving a complete response received monthly maintenance and were followed every 3months by cytology and cystoscopy.RESULTS: Three patients are still under treatment and will bc soon evaluated. Of 9patients, 2 (22%) achieved a complete response. Particularly, CRs were detected in patientstreated with 500 and 2000 mg. A PR was obtained in 2 (22%) more patients. No progressionm either ti or T-category was detected. The two patients with CR are disease-freerespectively at 8 and 3 months. Local tolerabtlity was excellent. No systemic side effectswere detected. Updated data will be presented.CONCLUSIONS: Our experience. although preliminary. shows the excellent tolerabilityand the potential efftcacy of gemcitabine when administered intravealcally for therapy ofsuperficial TCCB. The CR rate is 22%. This is apparently lower than that obtained wtthconventional drugs such as BCti, epirubicin or mitomycin C. but no dxect comparison canbe made since only 4 patient? have been actually treated at the higher dose. PR even if takeninto account, ts of uncertam prognostic significance.
Original languageEnglish
Pages (from-to)192-192
Number of pages1
Publication statusPublished - 2003


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