Prophylactic Levofloxacin lowers adverse events in bladder cancer patients treated with BCG therapy

Japan: A new study published in European Urology Focus shows that in individuals with non-muscle-invasive bladder cancer (NMIBC), prophylactic levofloxacin medication may lower the severity of adverse events and contribute to improved results after bacillus Calmette-Guerin (BCG) intravesical therapy.

Although bacillus Calmette-Guerin is a conventional treatment for high-risk non-muscle-invasive bladder cancer, there is still a significant occurrence of side effects of varying severity. Kazuyuki Numakura and colleagues investigated whether levofloxacin, administered after each intravesical instillation of BCG, may enhance tolerance without affecting effectiveness in patients with intermediate- to high-risk urothelial cancer of the bladder.

For this study, overall, 106 Japanese patients (85 men and 21 women; median age: 69.5 years) with primary or recurrent NMIBC were randomized to receive intravesical BCG with levofloxacin (group 1) or BCG alone (group 2). The intervention approach was explored, in which patients who had intravesical BCG instillation were randomized to receive levofloxacin or not. The National Cancer Institute-Common Toxicity Criteria version 3.0 were used to evaluate adverse events. To evaluate survival outcomes, cumulative incidence functions, and Kaplan-Meier techniques were used.

The key findings of this study were as follows:

1. The baseline features of the groups did not differ significantly. Group 1's completion rate (85.5%) was not substantially lower than Group 2's (76.5%).

2. There was no significant difference between groups in the completion rate of patients with pollakisuria, painful micturition, gross hematuria, temperature rise, and other symptoms.

3. In group 1, the incidence of adverse events was considerably lower in patients with high-grade pollakisuria (7.3% vs 25.4%) and fever (0% vs 9.1%).

4. Group 1 had considerably higher 5-year progression-free and cancer-specific survival rates.

In conclusion, Levofloxacin appears to be a safe and effective therapy for patients with non-muscle-invasive bladder cancer who are receiving bacillus Calmette-Guerin intravesical therapy.

Reference:

Numakura, K., Kobayashi, M., Ishida, T., Okane, K., Suzuki, K., Shimoda, N., Suzuki, T., Kumazawa, T., Sasaki, R., Fukuda, H., Kashima, S., Yamamoto, … Habuchi, T. (2022). 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. In European Urology Focus. https://doi.org/10.1016/j.euf.2022.06.002