Intravesical immunotherapy for superficial bladder cancer.

Objective: To compare and evaluate the efficacy and tolerance of intravesical instillation of Bacillus Calmette-Guerin (BCG) and interferon alpha-2b immunotherapy for superficial transitional cell carcinoma (TCC) of the urinary bladder.

Methods: Thirty-five patients with superficial TCC of the urinary bladder, primary and recurrent tumors, stage Ta, T1, and grade 1 and 2, were prospectively enrolled for intravesical immunotherapy at the Armed Forces Hospital, Riyadh, Kingdom of Saudi Arabia between January 1992 and December 2000. The treatment regimes used were either 120 mg of BCG weekly for 6 weeks followed by a 2nd 6 week course given only on first tumor recurrence, or 50 million i.u. of interferon alpha-2b weekly for 3 months, bi-weekly for the next 3 months and monthly for 6 months. Twenty-two patients received BCG and 13 received interferon alpha-2b. Adequate blood counts, renal and hepatic function profiles, and informed consent were required. Cystoscopy was repeated every 3 months for the first 2 years, then 6 monthly for another 2 years and then yearly.

Results: The follow-up period ranged from 9-96 months (median 31.33 months). Twenty patients attended the follow-up and were evaluable in the BCG group and 13 in the interferon alpha-2b group. In the BCG versus interferon alpha-2b group, the rates of complete response were 80% and 41.6%, partial response were 5% and 33.3%, and progression were 15% and 8.3%. Mild side effects occurred in 5 patients and all of them completed their treatments. There was only one cancer related death in each group after 6 and 7 years of starting the treatment.

Conclusion: Bacillus Calmette-Guerin was confirmed as a more effective intravesical immunotherapy for superficial TCC of the urinary bladder as compared to interferon alpha-2b. Both agents' treatments are well tolerated.