Objectives: To explore new treatment strategies in high-risk superficial bladder cancer patients, such as recurrent carcinoma in situ (CIS) or pT1 transitional cell carcinoma after intravesical bacillus Calmette-Guérin (BCG).
Methods: Mechanism of action, pharmacology and the results of clinical phase I and II trials with the oral biological response modifier bropirimine are reviewed.
Results: In a phase II trial in which CIS patients were treated, 17 complete responses were seen in 29 patients (59%) at the 3,000-mg dose level. Moreover, this trial indicated that bropirimine is a promising alternative in BCG recurrent or BCG intolerant patients: in 13 BCG failures, 6 complete responses were seen. Side effects are mild to moderate, mainly flu-like symptoms.
Conclusion: These results suggest that bropirimine is effective at 3,000 mg/day, and that patients with prior BCG therapy may be salvaged by bropirimine treatment.