4593 Background: The purpose of the trial designed for multiple superficial tumors of the bladder is to study the ablative or reductive activity of intravesical Gemcitabine on a papillary marker lesion Leaving a marker may be an interesting strategy: the effectiveness of the intravesical treatment can be assessed in a short period of time and furthermore the response the marker may turn out to be an important prognostic factor when correlated with the further recurrence rate. Gemcitabine can be considerate an ideal endovesical chemotherapy agent due to is high molecular weight, with no systemic absorption. Gemcitabine has been studied as a single agent in advanced or metastatic bladder cancer whit 24–28% of responses Methods: All patients with multiple primary and recurrent resectable histologically Ta T1 papillary TCC of the bladder will be considered for the trial all the visible lesions must be resected, except for one marker lesion The patient will then receive weekly instillations of Gemcitabine 2000mg in 50ml of sterile water during 8 weeks staring within 7–15 days after TUR. Control cystoscopy will be performed 12 weeks after TUR. If the marker lesion is still present or other growths are seen, they will be resected and biopsies of normal bladder mucosa performed. If no lesion is seen, a biopsy at the site of the marker will be taken. Results: We have 42 patients, 28 complete responses (66,6%) 14 non responders (33,3%). From 42 multiple patients, 24 are recurrent and 9 primary; 21 - Ta G1, 8 - TaG2, 4 - TaG3, 1 - T1G1, 28- T1 G2. In the non responders group there were no augmentation on TNM classification. Side effects in 6 patients, 2 had one case of hematuria and 4 had mild to strong dysuria Conclusions: We conclude that gencitabine is an active drug in bladder cancer and it wil be needed a randomized phase III protocol to have more data No significant financial relationships to disclose.
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