Levofloxacin safe and effective therapy for bladder cancer patients treated with BCG therapy: Study
Japan: The administration of prophylactic levofloxacin may reduce the severity of adverse outcomes in non-muscle-invasive bladder cancer (NMIBC) patients and contribute to better outcomes from bacillus Calmette-Guerin (BCG) intravesical therapy, says a recent study. The study was published online in European Urology Focus on 15 June 2022.
BCG is a standard treatment for high-risk non–muscle-invasive bladder cancer but there is a difficulty with the high rate of adverse events with a variety of grades. Kazuyuki Numakura, Department of Urology, Akita University Graduate School of Medicine, Akita, Japan, and colleagues, therefore, aimed to examine whether levofloxacin, given after each intravesical instillation of BCG, could improve its tolerance in patients with intermediate- to high-risk urothelial carcinoma of the bladder without compromising its efficacy in a randomized, prospective, multicenter study.
The study included 106 Japanese patients (85 men and 21 women; age: median, 69.5 yr) with primary or recurrent NMIBC. They were randomized after transurethral resection to induce treatment with intravesical BCG plus levofloxacin (group 1) or BCG alone (group 2). Patients who underwent intravesical instillation of BCG were randomized with or without levofloxacin administration.
The National Cancer Institute-Common Toxicity Criteria version 3.0 assessed adverse events. To estimate, survival outcomes, cumulative incidence functions and Kaplan-Meier methods were applied.
Based on the study, the authors found the following:
- There was no significant difference in baseline characteristics between the groups.
- The completion rate of group 1 (85.5%) was not significantly lower than that of group 2 (76.5%).
- There was no significant difference in the completion rate of patients with pollakisuria, painful micturition, gross hematuria, fever elevation, and others between the groups.
- The incidence of adverse events in patients with high-grade pollakisuria (7.3% vs 25.4%) and fever (0% vs 9.1%) was significantly lower in group 1.
- The 5-yr progression-free and cancer-specific survival rates were significantly better in group 1.
The authors conclude, "levofloxacin administration seems to be a safe and effective therapy for non–muscle-invasive bladder cancer patients treated with bacillus Calmette-Guerin intravesical therapy."
Reference:
The study titled, "Effect of Levofloxacin on the Efficacy and Adverse Events in Intravesical Bacillus Calmette-Guerin Treatment for Bladder Cancer: Results of a Randomized, Prospective, Multicenter Study," was published in the journal European Urology Focus.
DOI: https://doi.org/10.1016/j.euf.2022.06.002
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