BROPIRIMINE IMMUNOTHERAPY OF UPPER URINARY-TRACT CARCINOMA IN-SITU

Objectives. Bropirimine has been shown to be effective in treating app roximately 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 effecti ve in that setting. Methods. Twenty-four patients with negative radiog raphic findings and positive cytologic evidence for upper tract CIS in one or both ureters received bropirimine (3.0 g/day orally) for 3 con secutive days each week for up to 1 year. Ureteral collection of urine or barbotage for cytologic analysis was performed quarterly thereafte r. Results. Ten (48%) of 21 evaluable patients had a negative ureteral cytologic analysis after 12 weeks (5 patients) or 24 weeks (5 patient s). Of these 10 patients, 8 continue to have negative cytology for a p eriod of 3 to 30 months (median, more than 9 months). In 2 patients, n egative 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, 2, and 3 weeks due to pruritic rash, nausea and vomiting, and severe bone pain, respectively. Therap y was stopped in 1 additional patient between 4 and 5 months because o f transient liver enzyme elevations, yet this patient has had a contin uous negative cytologic analysis for more than 9 months. Conclusions. Orally administered bropirimine may be an 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 possib le need for maintenance or intermittent long-term therapy are warrante d.