title: Safety and efficacy of intravesical bacillus Calmette-Guerin instillations in steroid treated and immunocompromised patients.
abstract: OBJECTIVE
  We assessed the safety and efficacy of intravesical bacillus Calmette-Guerin instillations in steroid treated and immunocompromised patients.
  
  
  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.
authors.affiliation: Department of Urology, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA.
authors.forename: Ofer
authors.initials: O
authors.lastname: Yossepowitch
authors.forename: Scott E
authors.initials: SE
authors.lastname: Eggener
authors.forename: Bernard H
authors.initials: BH
authors.lastname: Bochner
authors.forename: S Machele
authors.initials: SM
authors.lastname: Donat
authors.forename: Harry W
authors.initials: HW
authors.lastname: Herr
authors.forename: Guido
authors.initials: G
authors.lastname: Dalbagni
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000008:administration & dosage* / Q000009:adverse effects; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000276:immunology*; D005260:Female; D006801:Humans; D016867:Immunocompromised Host; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013256:Steroids / Q000627:therapeutic use*; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000276:immunology*
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine; D013256:Steroids