title: Bropirimine immunotherapy of upper urinary tract carcinoma in situ.
abstract: OBJECTIVE
  Bropirimine has been shown to be effective in treating approximately 50% of patients with carcinoma in situ (CIS) of the bladder in recent clinical trials. Patients with upper tract CIS were treated with bropirimine to determine whether this oral drug might be effective in that setting.
  
  
  METHODS
  Twenty-four patients with negative radiographic findings and positive cytologic evidence for upper tract CIS in one or both ureters received bropirimine (3.0 g/day orally) for 3 consecutive days each week for up to 1 year. Ureteral collection of urine or barbotage for cytologic analysis was performed quarterly thereafter.
  
  
  RESULTS
  Ten (48%) of 21 evaluable patients had a negative ureteral cytologic analysis after 12 weeks (5 patients) or 24 weeks (5 patients). Of these 10 patients, 8 continue to have negative cytology for a period of 3 to 30 months (median, more than 9 months). In 2 patients, negative cytology reverted to positive at 6 and 9 months, respectively, during therapy. Twelve (50%) of the 24 patients reported no toxicity. Three patients stopped treatment at 2, 3, and 3 weeks due to pruritic rash, nausea and vomiting, and severe bone pain, respectively. Therapy was stopped in 1 additional patient between 4 and 5 months because of transient liver enzyme elevations, yet this patient has had a continuous negative cytologic analysis for more than 9 months.
  
  
  CONCLUSIONS
  Orally administered bropirimine may be effective therapy for CIS of the ureter or renal pelvis, with acceptable toxicity in most patients. Further efforts to better define this activity as well as the possible need for maintenance or intermittent long-term therapy are warranted.
authors.affiliation: Department of Urology, University of Texas Health Science Center, San Antonio 78284-7845, USA.
authors.forename: M F
authors.initials: MF
authors.lastname: Sarosdy
authors.forename: L L
authors.initials: LL
authors.lastname: Pisters
authors.forename: P R
authors.initials: PR
authors.lastname: Carroll
authors.forename: M C
authors.initials: MC
authors.lastname: Benson
authors.forename: T D
authors.initials: TD
authors.lastname: Moon
authors.forename: D L
authors.initials: DL
authors.lastname: Lamm
authors.forename: M A
authors.initials: MA
authors.lastname: Hudson
authors.forename: S P
authors.initials: SP
authors.lastname: Lerner
authors.forename: M O
authors.initials: MO
authors.lastname: Koch
authors.forename: P F
authors.initials: PF
authors.lastname: Schellhammer
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D002278:Carcinoma in Situ / Q000628:therapy*; D003596:Cytosine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014516:Ureteral Neoplasms / Q000628:therapy*
chemical_list: D000276:Adjuvants, Immunologic; D003596:Cytosine; C033560:bropirimine