Objective: To determine whether the new fluoroquinolone prulifloxacin might improve tolerance to Bacillus Calmette-Guérin (BCG) intravesical therapy in patients with bladder cancer.
Patients and methods: A series of 72 patients with intermediate- or high-risk nonmuscle-invasive bladder cancer were enrolled in this prospective, randomized, open-label, controlled clinical trial performed at a single tertiary care institution. After complete transurethral resection, patients were randomized to receive induction treatment with BCG and three capsules of prulifloxacin 600 mg or no prophylactic treatment (control group). Adverse events (AEs) were self-recorded by the patients after each instillation and classified by the investigator according to a classification grid considering account duration and intensity. Cystoscopy findings at 3 and 6 months were also recorded.
Results: There was no significant difference in baseline symptoms between the groups. Overall, there was a significant decrease in the percentage of patients with at least one AE between instillations in prulifloxacin-treated group. The proportion of patients with moderate to severe AEs after the fourth instillation was significantly less in the prulifloxacin-treated group. There was a significant effect of prulifloxacin on the need for anti-tuberculosis treatment. More patients in the control group stopped or delayed the full induction course of BCG instillations (34% vs 19%, P=0.04). Recurrence rates were not affected by prulifloxacin treatment.
Conclusion: Prulifloxacin reduces the incidence of moderate to severe AEs from BCG intravesical therapy in patients with nonmuscle-invasive bladder cancer, improving compliance to the induction BCG course. These preliminary findings warrant further clinical research.