Management of BCG non-responders with fixed dose intravesical gemcitabine in superficial transitional cell carcinoma of urinary bladder

Abstract

Aims and objectives: The incidence of bladder malignancy is increasing worldwide and the projected rise is 28% by 2010 for both sexes (WHO). Though intravesical adjuvant therapy with BCG is superior to any other immunotherapeutic/chemotherapeutic agent in reducing tumor recurrences and disease progression, its real efficacy remains controversial as one-third of the patients will soon become BCG failure. Hence there is a need for an alternative intravesical agent for treatment of BCG failure. Our aim was to study the efficacy, tolerability and safety of intravesical Gemcitabine in managing BCG-refractory superficial bladder malignancy.

Materials and methods: Thirty-five BCG failure patients, 26 males and nine females between 20-72 years of age were instilled with 2000 mg of Gemcitabine in 50 ml of normal saline intravesically two weeks post tumor resection, for six consecutive weeks. Mean follow-up was for 18 months with cystoscopies.

Results: Twenty-one patients (60%) showed no recurrences, 11 patients (31.4%) had superficial recurrences while three patients (8.6%) progressed to muscle invasiveness. Average time to first recurrence was 12 months and to disease progression was 16 months. Adverse event was low and mild. Therapy was well tolerated.

Conclusion: Gemcitabine fulfils all requirements as an alternative agent, in treating BCG failure patients with low adverse events, is well tolerated and highly effective in reducing tumor recurrences.

Keywords: BCG; gemcitabine; non-responders.