Intravesical sequential chemo - immunotherapy in superficial transitional cell bladder cancer

ABSTRACT

Thirty-five patients of [Ta/Tl] bladder tumors that initially treated with transurethral resection were randomized into three groups. Group A included patients received intravesical 2 g of gemcitabine in 100 ml saline once weekly for six consecutive weeks. Group B received 150 mg of BCG diluted in 50 ml saline once weekly for six consecutive weeks. Group C received sequential combination of weekly intravesical 2 g of gemcitabine in 100 ml saline for six consecutive weeks, then six weekly intravesical 75 mg of BCG diluted in 50 ml saline. After median follow up of 17 months, recurrence of progression was assessed as terminal events of the study. High risk cases that may have either multiple bladder lesions or more than grade I or associated with CIS were present in 72.7% and 66.7% in arm A, B and C, respectively. The most common local side effects were dysuria, hematuria, frequency and cystitis either bacterial or chemical. Systemic toxicities included neutropenia, thrombocytopenia, fever and malaise. Patients treated with intravesical chemo-immunotherapy had higher incidence of systemic toxicities. 36.4%, 66.7% and 75% were disease-free cases; however recurrence was present in 45.5%, 25% and 16.7% of cases in groups A, B and C, respectively