Complications of Bacillus Calmette-Guerin immunotherapy in superficial bladder cancer

Abstract

— Intravesical immunotherapy with BCG has become a standard treatment of superficial recurrent transitional cell carcinoma and in-situ bladder carcinoma. Studies on the mechanism of action have demonstrated the role of T lymphocytes. Moreover clinical and experimental results suggest a role by cytochines and delayed type hypersensitivity. BCG, while effective in the treatment of bladder cancer, has a defined morbidity that can be ascribed to the fact that it consists of viable bacterial cells. We evaluated the complications and side effects of this therapy in 71 patients who had received intravesical BCG (Pasteur strain BCG was instilled weekly for 6 weeks, fortnightly for three months and monthly for 12 months at a dose of 75 mg). Our findings showed the following complications: cystitis (63.3%), hematuria (28.1%), fever (7%), two cases of pruritus (2.8%), one case of hepatitis with persistent fever. Granulomatous prostatitis was noted in four cases (5.6%), a higher incidence than reported in literature, but it is a localized and self-limiting process that does not require specific therapy. In conclusion, the treatment with intravesical BCG has a significant morbidity, but the rate of complications is low and most need no treatment.