1769 UPDATED RESULTS OF THE COMBINED PHASE I/II TRIAL OF INTRAVESICAL NANOPARTICLE ALBUMIN-BOUND PACLITAXEL IN THE TREATMENT OF BCG REFRACTORY NON-MUSCLE INVASIVE TRANSITIONAL CELL CARCINOMA (2012)

You have accessJournal of UrologyBladder Cancer: Superficial II1 Apr 20121769 UPDATED RESULTS OF THE COMBINED PHASE I/II TRIAL OF INTRAVESICAL NANOPARTICLE ALBUMIN-BOUND PACLITAXEL IN THE TREATMENT OF BCG REFRACTORY NON-MUSCLE INVASIVE TRANSITIONAL CELL CARCINOMA James M. McKiernan, Dara D. Holder, Max Kates, Gina M. Badalato, Lamont J. Barlow, Arindam RoyChoudhury, Daniel Petrylak, and Mitchell C. Benson James M. McKiernanJames M. McKiernan New York, NY More articles by this author , Dara D. HolderDara D. Holder New York, NY More articles by this author , Max KatesMax Kates New York, NY More articles by this author , Gina M. BadalatoGina M. Badalato New York, NY More articles by this author , Lamont J. BarlowLamont J. Barlow New York, NY More articles by this author , Arindam RoyChoudhuryArindam RoyChoudhury New York, NY More articles by this author , Daniel PetrylakDaniel Petrylak New York, NY More articles by this author , and Mitchell C. BensonMitchell C. Benson New York, NY More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.1786AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Up to 50% of patients treated with intravesical agents for non-muscle invasive bladder cancer (NMIBC) will recur. Response rates to current second-line intravesical therapies average less than 20%. For these high risk patients, novel agents are necessary. Nanoparticle albumin-bound (nab-) paclitaxel has been shown to have increased solubility and lower toxicity compared to docetaxel in systemic therapy trials.It is therefore an appropriate candidate for further investigation as an intravesical agent. Results of the Phase I trial demonstrated minimal toxicity and systemic absorption during dose escalation. We now report the results of the ongoing Phase II trial. METHODS In January 2010, accrual began for the IRB approved phase II trial investigating the use of (nab-) paclitaxel for BCG refractory NMIBC. Inclusion criteria included patients with recurrent high grade (HG) Ta, T1, and Tis transitional cell carcinoma who failed at least one prior regimen of BCG. In accordance with the dosing determinations from Phase I data, 500mg of nab-paclitaxel was administered in six weekly intravesical instillations . The primary endpoint was response rate. Efficacy was evaluated by cystoscopy, biopsy, cytology, and imaging. If there was no evidence of disease, patients could elect to undergo maintenance treatment at 3, 6, 12, 18, 24 and 36 mos. Safety and toxicity profiles were monitored throughout. RESULTS As of November 1st 2011, nineteen of the targeted 29 patients had been enrolled. Three patients were withdrawn from the study: one due to non-study related pneumonia and sepsis; one withdrew consent; and one had a grade II urinary tract infection (UTI). Three patients (16%) had no evidence of disease at their initial post-treatment cystoscopy and became eligible for maintenance therapy. To date, these patients were free of disease at 5, 18 and 21 months following enrollment. Of the 16 patients who did not respond, no patient had progression of their disease. Local grade 1 toxicities were observed in 10/19 (52%) of patients, with UTIs being the most common. There was only 1 grade II complication, a Pseudomonas aeruginosa UTI. CONCLUSIONS Intravesical nab-paclitaxel has minimal toxicity and a 16% response rate in patients with non-muscle invasive disease and previous BCG failure. Completion of accrual is expected in April 2012. Long-term follow-up and quality of life will be reported at that time. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e714 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information James M. McKiernan New York, NY More articles by this author Dara D. Holder New York, NY More articles by this author Max Kates New York, NY More articles by this author Gina M. Badalato New York, NY More articles by this author Lamont J. Barlow New York, NY More articles by this author Arindam RoyChoudhury New York, NY More articles by this author Daniel Petrylak New York, NY More articles by this author Mitchell C. Benson New York, NY More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...