African Journal of Urology

Log in or Register to get access to full text downloads.

Remember me or Register

Intravesical Gemcitabine for Treatment of Superficial Bladder Cancer not Responding to Bacillus Calmette-Guérin Vaccine

MA Elkoushy


Objectives: Intravesical Bacillus Calmette-Guérin (BCG) vaccine is the mainstay of treatment and prophylaxis in superficial bladder cancer (SBC) as it reduces tumor recurrence and disease progression. About one-third of patients do not respond to BCG. The aim of this study was to determine the efficacy of intravesical gemcitabine in patients with BCG-refractory SBC.
Methods: Twenty three patients with SBC; TaG3, T1G2-G3 or carcinoma in situ (CIS), refractory (after at least 2 courses of intravesical BCG) or intolerant to intravesical BCG therapy were included. Two weeks after complete tumor resection, patients received intravesical gemcitabine twice weekly at a dose of 2.000 mg/100 ml normal saline for 6 consecutive weeks. Two months after the last dose, recurrence-free patients underwent cystoscopy, urinary cytology and 6 random bladder biopsies. Thereafter, patients were evaluated by the same measures every 3 months, as long as there was no recurrence. Patients with complete response (negative cytology and random biopsies) at the first follow-up cystoscopy received a similar maintenance dose once weekly for another 6 weeks. Results: Twenty one patients completed the study: 15 males and 6 females with a mean age of 48.1 (38-72) years. The follow-up was 15 months (range 2-19 months). Thirteen (61.9%) patients were recurrence-free after a mean of 17 months. Superficial recurrences were detected in 6 (28.6%) patients and progression by stage in 2 patients (9.5%). During follow-up, 8 patients had tumor recurrences and 2 had progression to a higher stage. The median recurrence-free time was 14.7 months (5-19 months). The drug was well tolerated and side-effects were mild in all patients, except two: one had easily controlled hematuria and the other had leucopenia.
Conclusion: In properly selected patients, gemcitabine seems to be a promising option in the management of high-risk BCG-refractory SBC, especially in those who refuse or are unfit for cystectomy. Long-term efficacy and the role of maintenance therapy have to be properly studied.

Key Words: Superficial bladder cancer, BCG, gemcitabine, intravesical
AJOL African Journals Online