BERLIN, GERMANY (UroToday.com) - Mitchell C. Benson, MD, Professor and Chair of Urology at Columbia University Medical Center reported on his institutional experience with intravesical docetaxel as a salvage therapy for patients with high grade disease who had failed at least one course on intravesical BCG.

In the initial Phase I study of 18 patients authored by Dr. James M. McKiernan, their group demonstrated that a single 6 week course of docetaxel was safe and demonstrated efficacy in this clinical setting. The initial complete response rate was 56%, but the durable response rate was 22% with an additional 17% rendered NED by a second TURBT.

Owing to the low durable response rate, an additional 13 patients were given 75 mg of docetaxel in 100 ml normal saline once weekly for 6 weeks. If at their 3 month cystoscopy they were biopsy negative, they went on to receive monthly docetaxel for an additional 9 months, or one year of therapy in total.

Ten of 13 patients or 77%, had an initial complete response, and the durable response with a mean follow-up of 9 months was 9 of 13 patients or 69%.

Dr. Benson concluded that BCG refractory non-muscle invasive bladder cancer represents a therapeutic challenge. Although radical surgery is and should be considered the standard of care, it may be over-treatment for some patients and it presents quality-of-life issues. Additionally, some patients are not good surgical candidates or may refuse surgery. For these patients, intravesical docetaxel appears to be an effective option - seemingly more so than either valrubicin or gemcitabine, though only a randomized comparison can definitively establish their relative efficacies.

Presented by Mitchell C. Benson, MD, at the Annual Meeting of the AUA - New York Section - September 6 - 13, 2008 - Berlin, Germany

Written by UroToday.com Contributing Editor Mitchell C. Benson, MD

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