A review of clinical studies of bropirimine immunotherapy of carcinoma in situ of the bladder and upper urinary tract.
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.
Sarosdy
M F
MF
Division of Urology, University of Texas Health Science Center, San Antonio 78284-7845, USA.
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
D000276:Adjuvants, Immunologic; D000970:Antineoplastic Agents; D003596:Cytosine; C033560:bropirimine