Current Issue UroToday Int J. 2009 Oct;2(5). doi:10.3834/uij.1944-5784.2009.10.13
Safety and Efficacy of Ofloxacin on Bacillus Calmette-Guerin Induced Toxicity in Patients with Superficial Bladder Cancer
INTRODUCTION: The purposes of the present prospective study were: (1) to investigate the role of a fluoroquinolone (ofloxacin) in reducing the side effects of bacillus Calmette-Guerin (BCG) therapy in patients with nonmuscle invasive bladder cancer; (2) to determine if ofloxacin had any influence on the antitumor efficacy of the BCG therapy.
METHODS: From December 2006 to December 2007, 100 consecutive patients were enrolled in the study. Patients were randomly assigned to group 1 (n = 50) to receive ofloxacin or group 2 (n = 50) to receive a placebo. The groups were similar in patient age, sex, tumor stage, and tumor grade. Patients were followed for 12 months. The efficiency of the BCG therapy was determined clinically using an adverse event scale index. The patients were also evaluated endoscopically.
RESULTS: During the study period, there were 267 adverse events occurring after more than 850 BCG instillations. A significant decrease of burning with micturition was noted in group 1 (n = 41) when compared with group 2 (n = 19) (P = .03). Ofloxacin did not significantly reduce the occurrence of any other mild, moderate, or severe adverse events. After a follow-up of 12 months, results showed that ofloxacin did not affect the efficacy of BCG therapy. There were no significant differences between the 2 groups in disease recurrence or progression rates.
CONCLUSION: Instituting antibiotic prophylaxis with ofloxacin after each BCG instillation appears to be an efficient and safe method of improving treatment tolerability for burning with micturition. Ofloxacin reduced this adverse event without serious consequences. By decreasing the burning symptoms, patients may be more inclined to continue the BCG treatment.
KEYWORDS: Bladder; Transitional cell carcinoma; BCG therapy; Adverse events;
CORRESPONDENCE: Yassine Nouira, 5 Rue Ibn Messaoud El Menzah 6 – 2091, Ariana, Tunisia (nouirayassine@gnet.tn).
CITATION: Urotoday Int J. 2009 Oct;2(5). doi:10.3834/uij.1944-5784.2009.10.13
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