Reducing Toxicity in Bladder Cancer Therapy

NEW YORK OCT 19, 2006 (Reuters Health) - Prophylaxis with ofloxacin decreases the toxicity of bacillus Calmette-Guerin (BCG) treatment of transitional cell carcinoma of the bladder, according to French researchers.

In the September issue of The Journal of Urology, Dr. Marc Colombel of Hopital Edouard Herriot, Lyon, and colleagues note that immunotherapy with BCG is highly effective in helping prevent recurrence of certain bladder tumors.

However, although major BCG-related complications are seen in fewer than 5% of patients, as many as 80% may suffer from mild and moderate adverse events. These are largely due to BCG-induced inflammation.

To investigate whether the tuberculostatic properties of ofloxacin might be helpful under these circumstances, the researchers studied 115 patients with primary or recurrent superficial bladder cancer and no previous BCG treatment. They were randomized to 9 BCG instillations along with ofloxacin 200 mg or placebo.

In the active treatment group, there was a significant 18.5% reduction in the incidence of moderate or more severe adverse events between instillations 4 and 6. There was also a significant reduction in the proportion of severe adverse events between instillations 1 and 9.

Although the difference was not significant, the reduction in adverse events also appeared to improve compliance. In total, 80.7% of the ofloxacin group received all 9 instillations compared to 65.5% of placebo patients.

At 12 months, cancer recurrence was 12.7% in the ofloxacin group versus 17.2% in placebo patients. The corresponding rates for progression were 5.5% and 1.7%.

The researchers call for longer follow-up, but conclude that the approach reduced adverse events, particularly severe ones, and may have reduced the patient drop-out rate.

SOURCE:

• J Urol 2006;176:935-939.