The Effect Of Ofloxacin On Bacillus Calmette-Guerin Induced Toxicity In Patients With Superficial Bladder Cancer: Results

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 20 May 2007 - 0:00 PDT

email to a friend   printer friendly   opinions  

UroToday.com- BCG immunotherapy is the current 'gold standard' for treatment of non-muscle invasive bladder cancer. It is the only therapy which has been shown to decrease both recurrence as well as progression however, for maximal benefit it is important that patients receive 'maintenance' therapy up to 3 years. Nonetheless, practitioners often find that patients are unable to tolerate such therapy due to significant side effects thus limiting the number of doses each patient receives.

There are numerous proposed methods in which the side effect profile of BCG instillation can be reduced including, careful attention to instillation technique and reduction in dose after sensitization of patients. In an interesting and promising study, Colombel and colleagues studied the effect of quinolone antibiotic administration on improving the tolerance of intravesical BCG instillations following prophylactic ingestion of ofloxacin. This is a secondary objective of evaluating the effect on therapeutic efficacy of BCG instillations, since prior reports have suggested in vitro efficacy of such antibiotics against bladder cancer cells. The study randomized patients into 2 groups, one group (n= 57) received ofloxacin 6 h after 1st micturition and 10-12 h after 1st ingestion after each BCG (6+3) instillation and was compared to group two a placebo group (n=58).

The authors found that ofloxacin significantly decreased the incidence of class II or higher moderate and severe adverse events by 18.5%, as well as class III events by 21.5% (p=0.019). Compliance with BCG treatment was also improve with 80.7% of patients in the ofloxacin group who were able to receive all 9 instillations compared with 65.5% in placebo group (p = 0.092). At 12 months recurrence and progression rates both groups were similar at 12.7% and 17.2%, and 5.5% and 1.7%, respectively. It should be noted however, that that study was not powered to demonstrate equivalence of efficacy.

This is the first study to show that adjuvant antibiotic prophylaxis is a valid strategy to prevent BCG-related side effects and improve patient compliance with no evident loss of efficacy. This strategy, combined with dose reduction of BCG should allow most patients to receive the 'full prescribed course' of BCG thus improving their odds of response to therapy.

Colombel M, Saint F, Chopin D, Malavaud B, Nicolas L, Rischmann P.

J Urology 176(3) : 935-939, September 2006
doi:10.1016/j.juro.2006.04.104

Reported by UroToday.com Contributing Editor Ashish M. Kamat, MD

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to: www.urotoday.com

Copyright © 2006 - UroToday

• Additional
• References
• Citations