For patients with advanced bladder cancer who are medically unfit for standard treatment, a new intravesical (inside the bladder) chemotherapy delivery system called TAR-200 is safe and shows initial evidence of effectiveness, reports a study in the May issue of The Journal of Urology, an Official Journal of the American Urological Association (AUA). The journal is published in the Lippincott portfolio by Wolters Kluwer.
In the new phase one study, TAR-200 was used in 35 patients with MIBC: 24 men and 11 women, median age 84 years. The patients were deemed medically ineligible for standard surgery (radical cystectomy) and chemotherapy or opted not to receive this treatment. All patients underwent minimally invasive surgery (transurethral resection of bladder tumor, or TURBT) to remove visible tumor.
The patients then underwent a simple procedure to place the TAR-200 device, which released gemcitabine over 21 days. At that time, another procedure was performed to remove and replace the device, for a total of four treatments over 84 days.
TAR-200 treatment was safe and well-tolerated, assessments suggested. About one-fourth of patients had problems related to device placement or treatment procedures. About 40% had some kind of treatment-related adverse event, most commonly related to problems with urination. These relatively minor problems were "as expected" in a group of frail elderly patients with MIBC, according to the authors. Just two patients were considered "not tolerant" of TAR-200, requiring device removal.
Overall, 11 of 35 patients had a complete tumor response to TAR-200, with no evidence of bladder cancer at follow-up. Three more patients had a partial response, for an overall response rate of 40%. Median overall survival was about 27 months. That compared to a 12 overall survival rate in previous studies of MIBC patients not receiving curative-intent treatment.
Among 14 patients with lasting responses to TAR-200 treatment, 70.5% remained free from progressive bladder cancer at 12 months after treatment.
