Safety and efficacy of intravesical bacillus Calmette-Guérin instillations in steroid-treated and immunocompromised patients

Abstract

14507 Background: We assess the safety and efficacy of intravesical bacillus Calmette-Guérin (BCG) for high-risk superficial bladder cancer in steroid-treated and immunocompromised patients. Methods: We retrospectively reviewed charts of 697 patients treated with BCG instillations from 1991 to 2004. In 24 patients (3.5%), either an underlying comorbidity directly affecting the immune system was diagnosed before BCG administration, or steroids were administered at least 6 weeks before and at the time of BCG instillations. The immunosuppressive effect of the steroids was assessed by percentage of lymphocytes. End-points were BCG response at 6 months (defined as normal cystoscopy, cytology, and biopsy when available) and treatment-related toxicity. Results: Four patients (17%) had an active lymphoma or chronic lymphocytic leukemia during administration of BCG, and 21 (88%) had a concurrent condition for which oral steroids (11 patients), inhaled steroids (14 patients), or both (4 patients) were administered. Patients treated with oral steroids had a lower percentage of lymphocytes (12.3%) compared to patients treated with inhaled steroids (17.5%) or 15 age-matched patients with high-risk superficial bladder cancer and no steroid treatment (18.6%). The overall BCG response rate at 6 months was 58%. Of the 24 patients, 10 had disease recurrence and 3 had disease progression at a median follow-up of 63.5 months (IQR 19.5, 89). One patient treated with oral steroids developed a self-limited febrile disease and worsening of myalgia 48 hours after his third BCG cycle. No other systemic adverse event following BCG therapy was recorded, and all patients completed their scheduled treatments. Conclusions: Intravesical BCG is a viable therapeutic option for 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 BCG response rate at 6 months and the side effects profile associated with BCG therapy in these patients are comparable to patients with no evidence of immunosuppression. Further studies are warranted to assess the safety and efficacy of BCG instillations in critically immunocompromised patients. No significant financial relationships to disclose.