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.

Role of Tumor Suppressor and Angiogenesis Markers in Prediction of Recurrence of Non Muscle Invasive Bladder Cancer

“…Informed consent from patients and Institutional ethics committee was obtained. All patients had intermediate and high risk and were treated with TURBT followed by BCG [4]. Resected tumour tissue was divided into two parts, one part for formalin fixed, paraffin embedded tissue and the other part was minced and a cell spot was prepared for immunoflourescent (IF) staining.…”

“…These cancers constitute more than 80% of bladder cancer and of these more than 70% patients recur within the first 2 years of diagnosis [2]. Hence it is imperative to treat these tumours with Transurethral resection of bladder tumour (TURBT) followed by adjuvant intravesical BCG in the intermediate and high risk groups [3,4]. Tumour suppressor genes (p53) have been identified as potential predictors for recurrence, but the estimated hazard rate seems variable [5,6].…”