Bropirimine, an Orally Active Anticancer Agent for Superficial Bladder Cancer

Abstract

Objective: To investigate efficacy and safety of bropirimine, a new orally active interferon inducer, in patients with superficial bladder cancer. Methods: Twenty patients with histologically confirmed recurrent superficial transitional cell carcinoma (T_a or T₁) were studied. At least one marker lesion remained in all patients after transurethral resection. Bropirimine (750 mg) was given orally three times at 2-hour intervals (daily dose 2,250 mg) on 3 consecutive days weekly for 12 weeks. Results: Of the 17 evaluable patients, 1 did not complete the treatment protocol. There were 5 responders, including 2 with a complete response (complete disappearance of the marker tumor) and 3 with a partial response (>50% reduction of the marker tumor). The objective response rate was 31.3% (5/16; 95% confidence interval 11.0–58.7%) for the 16 patients completing treatment and 29.4% (5/17; 95% confidence interval 10.3–56.0%) for the 17 evaluable patients. Adverse reactions occurred in 70.6% of the evaluable patients. Flu-like symptoms were most common, including malaise (23.5%), headache (23.5), and fever (11.8%), followed by gastrointestinal symptoms including less of appetite (23.5%). All of these reactions were tolerable. Conclusions: Bropirimine may be useful for the prophylaxis of recurrence following transurethral resection of superficial bladder cancer because it shows efficacy against marker tumors and has a good safety profile and oral activity.