Abstract
4591 Background: Current intravesical treatments of Ta-T1 urinary bladder cancer have shown good efficacy, but improvement is needed. We evaluated the efficacy and toxicity of 3 different dose regimens of gemcitabine administered intravesically to patients with urinary bladder cancer. Methods: Patients with histologically proven stage Ta, grade 1/2 urinary bladder cancer and a marker lesion diameter of 0.5 to 1 cm after transurethral resection were enrolled; they received gemcitabine 2000 mg that was instilled and kept in the bladder for 1 hour. Patients were randomized to one of the following regimens: 1 dose (group A); 2 doses/week for 3 weeks (group B); or 1 dose/week for 6 weeks (group C). Response was assessed via cystoscopy 9 weeks after the end of treatment. Results: Between January 2002 and March 2004, 32 patients were enrolled; 2 were excluded due to protocol violations (groups B and C). Of the 30 randomized patients (11, group A; 10, group B; 9, group C), 1 patient was not evaluable for efficacy (group A). Nine patients (31%) reported a complete response (1, group A; 4, group B; 4, group C); an additional 9 patients (31%) had no response; and 11 (38%) had a tumor increase. All 30 patients were evaluable for toxicity. No NCI-CTC grade 3/4 toxicity was observed. Grade 1/2 nausea was reported in 5 patients (17%), and grade 1/2 fever in 2 patients (7%). One patient (3%) had grade 1 thrombocytopenia, which was reversible, and 1 of the patients with fever had grade 1 anemia, which was also reversible. Instillations were discontinued due to toxicity for only 1 patient (nausea, fever). Ten patients (33%) were unable to retain the drug for the full hour. Conclusions: As an intravesical instillation, gemcitabine showed activity and was well tolerated. The single-dose regimen does not appear to be effective. Also, twice-weekly doses do not appear to be more effective than once-weekly doses. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly
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