Intravesical gemcitabine in superficial bladder tumors. Results of a phase I-II study

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the good tolerability of intravesical gemcitabine have been recently published. The evaluationof the activity on a papillary marker lesion is the best tool to measure the efficacy of a drugby intravesical route against superficial transitional cell carcinoma of the bladder (TCCB).The scientific background and the ethical acceptability of this approach have been validatedby the European Organization for Research and Treatment of Cancer Urological Group. Theaim of the present study was to evaluate the ablative efficacy of weekly intravesicalinstillations of gemcitabine against a histologically proven papillary marker lesion.MATERIAL & METHODS: Twenty-seven patients, affected by recurrent multiplesuperficial TCCB (Ta-Tl, Gl-G2), were treated with intravesical gemcitabine after atransurethral resection (TUR) during which 1 to 3 papillary marker lesions (5-15 mm indiameter) were left unresected. High grade (G3) hanours and Tis were excluded. Twenty-onepatients (77.7%) had been treated in the past with adjuvant intravesical chemotherapy (BCGin 2 cases). Seventeen (63%) patients had multiple (2.3) marker lesions, all less than 10mm.Starting 14 days after TUR, 6 instillations of gemcitabine were given at weekly intervals.Gemcitabine, diluted in 50 cc of saline solution and maintained in the bladder for two hours,was given at the dose of 500 mg, 1000 mg and 2000 mg in groups of 9 patients each. Thepatients, 14-21 days after the last instillation, were submitted to cytology, cystoscopy andTUR or cold cup biopsy of every suspicious lesion and at the sites of the marker lesions.Complete response (CR) was defined as negative cytology, cystoscopy and biopsy. Partialresponse (PR) was defined as a reduction in number of multiple lesions. Local and systemictoxicity was investigated at weekly intervals. Routine laboratory tests were carried every 4weeks. Patients achieving a complete response received monthly maintenance up to one yearand were followed every 3 months by cytology and cystoscopy.RESULTS: One patient treated at the dose of 500mg is not evaluable for response since hewas lost at follow-up after the 6” instillation. Out of the remaining 26 patients, 6 (23%)achieved a complete response. Particularly, 1 (12.5%), 2 (22.2%) and 3 (33.3%) CRs wereobtained at the dose of 500, 1000 and 2000 mg, respectively. A PR was obtained in 2 (22%)more patients (500 and 1000 mg). No progression in either G or T-category was detected.Bladder Tis was diagnosed in 2 complete responders at 8 and 3 months respectively. Theremaining 4 patients are disease free up to 17 months. Local tolerability was excellent andnever required treatment interruption. No systemic side effects were detected.CONCLUSIONS: Our experience, although preliminary, shows the excellent tolerability andthe potential efficacy of gemcitabine when administered intravesically against TCCB. A CRrate up to 33% has been obtained.
Lingua originaleEnglish
Numero di pagine1
Stato di pubblicazionePublished - 2004


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