title: Intravesical mycobacterial cell wall-DNA complex in the treatment of carcinoma in situ of the bladder after standard intravesical therapy has failed.
abstract: OBJECTIVE
  We assessed the clinical efficacy and safety of mycobacterial cell wall-DNA complex after intravesical administration in patients with carcinoma in situ in whom prior therapy with bacillus Calmette-Guerin failed or in those who were treatment naïve.
  
  
  METHODS
  Patients received 6 weekly instillations of 4 or 8 mg mycobacterial cell wall-DNA complex (formulated as an emulsion) followed by 3 weekly instillations at weeks 12 and 24. Efficacy and safety were evaluated throughout the treatment phase and at months 12 and 18.
  
  
  RESULTS
  A total of 55 patients (mean age 74 years, 74.6% male) received 4 mg (25) or 8 mg (30) mycobacterial cell wall-DNA complex emulsion. All patients were previously treated with bacillus Calmette-Guerin except for 8 who were treatment naïve and 2 who received chemotherapy. In the intent to treat population the complete response rate was 27.3% at weeks 12 and 26 in the 4 mg group while 46.4% of patients receiving 8 mg had a complete response at both points. Mycobacterial cell wall-DNA complex was well tolerated by both dose groups. Overall 90% of all adverse events were mild to moderate in severity.
  
  
  CONCLUSIONS
  Mycobacterial cell wall-DNA complex has shown antineoplastic activity in patients with bladder cancer with less toxicity than that associated with bacillus Calmette-Guerin administration. The tolerance and efficacy of mycobacterial cell wall-DNA complex might hold promise for the treatment of carcinoma in situ of the bladder.
authors.affiliation: Queen's University, Kingston, Ontario, Canada.
authors.forename: Alvaro
authors.initials: A
authors.lastname: Morales
authors.forename: Kiran
authors.initials: K
authors.lastname: Phadke
authors.forename: Gary
authors.initials: G
authors.lastname: Steinhoff
mesh_terms: D000283:Administration, Intravesical; D000368:Aged; D000369:Aged, 80 and over; D002278:Carcinoma in Situ / Q000628:therapy*; D002473:Cell Wall; D004269:DNA, Bacterial / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009161:Mycobacterium / Q000235:genetics; D017211:Treatment Failure; D001749:Urinary Bladder Neoplasms / Q000628:therapy*
chemical_list: D004269:DNA, Bacterial