Low-dose bacille Calmette–Guerin for non-muscleinvasive bladder cancer: Results of a prospective study

Objective: To evaluate the efficacy and safety of low-dose (45 mg) intravesical bacille Calmette–Gue´rin (BCG) therapy in the treatment of patients with non-muscle-invasive bladder cancer (NMIBC), as intravesical BCG is the most acceptable adjuvant therapy for NMI transitional cell carcinoma of the bladder. However, in the standard regimen, undesirable effects are the main cause of treatment discontinuation. Patients and methods: The present study included 37 men with primary NIMBC. All patients underwent complete TURB and 2 weeks later, a 6-week course of 45 mg BCG diluted in 50 mL isotonic saline was instilled into the bladder and retained for 2 h. Patients were evaluated for BCG efficacy (recurrence with or without progression) and safety by documentation of minor and/or major side-effects. Results: There were no major or severe side-effects and no treatment discontinuations. Local adverse effects occurred in 20 patients, while systemic effects, in the form of fever, occurred in six patients (16.2%). There was recurrence in 14 patients (37.8%) after 18–34 months, with disease progression (muscle invasion) in four (10.8%) after 6–18 months. The recurrence index was 0.39/100 patients/month and the mean (range) tumour-free period was 30.97 (7–36) months. Conclusion: Low-dose BCG intravesical therapy is an effective adjuvant treatment in NMIBC. However, this needs to be validated in future studies and in comparison with other proposed doses and/or regimens.