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Randomized phase III trial on gemcitabine versus mytomicin in recurrent superficial bladder cancer: Evaluation of efficacy and tolerance
Journal of Clinical Oncology, 10/26/09

Addeo R et al. – This study demonstrates that GEM has better efficacy and lower toxicity than MMC; therefore, GEM appears as a logical candidate for intrabladder therapy in patients with refractory transitional cancer.

Methods

Patients with history of previously treated, recurrent Ta-T1, G1-G3 bladder transitional cell carcinoma enrolled
Patients received a 6-week course of GEM infusions or 4-week course of MMC
For initial responders who remained free of recurrences, maintenance therapy consisted of 10 monthly treatments during the first y

Results

120 patients enrolled and randomly assigned to either MMC or GEM treatment arm
At end of study, 109 patients (55 in MMC and 54 in GEM) assessable
Median duration of follow-up 36 months for either arm
In GEM arm, 39 (72%) of 54 patients remained free of recurrence versus 33 (61%) of 55 in MMC arm
Among patients with recurrences, 10 in MMC arm and six in the GEM arm also had a progressive disease by stage
Incidence of chemical cystitis in MMC arm statistically higher than in GEM arm

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