title: A review of clinical studies of bropirimine immunotherapy of carcinoma in situ of the bladder and upper urinary tract.
abstract: OBJECTIVE
  Bropirimine has been shown to have activity against carcinoma in situ (CIS) of the bladder in a previous phase-I trial. A review of three completed clinical trials as well as ongoing studies is presented to provide a current update.
  
  
  METHODS
  Details of the initial phase-I trial are reviewed, as are findings of a subsequent phase-II trial in bladder CIS and a multicenter study in upper tract CIS. All have used a dose of 3 g/day for 3 consecutive days each week, repeated weekly for up to 1 year. Cytology must be positive prior to treatment, and both biopsies and cytology must be negative after therapy for the patient to be considered a complete response.
  
  
  RESULTS
  In the phase-II trial in bladder CIS, 20 (61%) of 33 patients had a complete response. Responders included patients with prior bacillus Calmette-Guérin (BCG) therapy, uni- and multifocal CIS, and primary and secondary CIS. Responses were seen in 10 (48%) of 21 evaluable patients with upper tract CIS. Toxicities in both studies were manageable in most patients. Trials underway include bropirimine in BCG-failed CIS, a randomized comparison to BCG in previously untreated patients, and a trial of the two together.
  
  
  CONCLUSIONS
  Bropirimine does have activity against both bladder and upper tract CIS on the dose schedule used to date.
authors.affiliation: Division of Urology, University of Texas Health Science Center, San Antonio 78284-7845, USA.
authors.forename: M F
authors.initials: MF
authors.lastname: Sarosdy
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000473:pathology; D002986:Clinical Trials as Topic; D003596:Cytosine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007167:Immunotherapy; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D014516:Ureteral Neoplasms / Q000188:drug therapy* / Q000473:pathology; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000276:Adjuvants, Immunologic; D000970:Antineoplastic Agents; D003596:Cytosine; C033560:bropirimine