PURPOSE: We assessed the safety and efficacy of intravesical bacillus 
Calmette-Guerin instillations in steroid treated and immunocompromised patients.
MATERIALS AND METHODS: We retrospectively reviewed the charts of 697 patients 
treated with bacillus Calmette-Guerin instillations at our institution from 1991 
to 2004. In 24 patients (3.5%) an underlying comorbidity directly affecting the 
immune system was diagnosed before bacillus Calmette-Guerin administration or 
steroids were administered at least 6 weeks before and at the time of bacillus 
Calmette-Guerin instillations. The immunosuppressive effect of steroids was 
assessed by the percent of lymphocytes. End points were the bacillus 
Calmette-Guerin response at 6 months, defined as normal cystoscopy, cytology and 
biopsy when available, and treatment related toxicity.
RESULTS: Four patients (17%) had active lymphoma or chronic lymphocytic leukemia 
during bacillus Calmette-Guerin administration and 21 (88%) had a concurrent 
condition for which oral steroids (11), inhaled steroids (14) or oral and 
inhaled steroids (4) were administered. Patients treated with oral steroids had 
a lower percent of lymphocytes than patients treated with inhaled steroids and 
15 age matched patients with high risk superficial bladder cancer and no steroid 
treatment (12.3% vs 17.5% and 18.6%, respectively). The overall bacillus 
Calmette-Guerin response rate at 6 months was 58%. Ten of the 24 patients had 
disease recurrence and 3 had disease progression at a median followup of 63.5 
months (IQR 19.5, 89). One patient treated with oral steroids had self-limited 
febrile disease and worsening of myalgia 48 hours after his third bacillus 
Calmette-Guerin cycle. No other systemic adverse event following bacillus 
Calmette-Guerin therapy was recorded and all patients completed scheduled 
treatments.
CONCLUSIONS: Intravesical bacillus Calmette-Guerin is a viable therapeutic 
option in patients with high risk superficial bladder cancer and concomitant 
lymphoma or chronic lymphocytic leukemia, treatment with low dose oral steroids 
or treatment with inhaled steroids. The bacillus Calmette-Guerin response rate 
at 6 months and the side effects profile associated with bacillus 
Calmette-Guerin therapy in these patients were comparable to those in patients 
with no evidence of immunosuppression. Further studies are warranted to assess 
the safety and efficacy of bacillus Calmette-Guerin instillations in critically 
immunocompromised patients.