Phase II trial of intravesical nanoparticle albumin bound paclitaxel for the treatment of nonmuscle invasive urothelial carcinoma of the bladder after bacillus calmette-guérin treatment failure

James M. McKiernan, Dara D. Holder, Rashed A. Ghandour, Lamont J. Barlow, Jennifer J. Ahn, Max Kates, Gina M. Badalato, Arindam Roychoudhury, G. Joel Decastro, Mitchell C. Benson

Research output: Contribution to journalArticle

Abstract

Purpose Response rates to current second line intravesical therapies for recurrent nonmuscle invasive bladder cancer range between 10% and 30%. Nanoparticle albumin bound (nab-)paclitaxel has increased solubility and lower toxicity compared to other taxanes. Results of the phase I intravesical trial of this compound demonstrated minimal toxicity during dose escalation. We now report the results of a phase II trial to assess efficacy.

Materials and Methods This study was an investigator initiated, single center, single arm, phase II trial investigating the use of nab-paclitaxel in patients with recurrent Tis, T1 and Ta urothelial carcinoma in whom at least 1 prior regimen of intravesical bacillus Calmette-Guérin failed. Patients received 500 mg/100 ml nab-paclitaxel administered in 6 weekly intravesical instillations. Efficacy was evaluated with cystoscopy, biopsy, cytology and imaging. If complete response was achieved, patients were treated with full dose monthly maintenance treatments for 6 months.

Results A total of 28 patients were enrolled in the study. Of these patients 10 (35.7%) exhibited a complete response after initial treatment. At 1 year all of these responses remained durable after maintenance therapy. At a mean followup of 21 months (range 5 to 47) 19 of 28 (67.8%) patients retained their bladders without progression or distant metastases. A single patient had progression to muscle invasive disease at radical cystectomy. Treatment related adverse events were noted in 9 of 28 (32.1%) patients and were limited to grade 1 or 2.

Conclusions Intravesical nab-paclitaxel has minimal toxicity and a 35.7% response rate in patients with nonmuscle invasive bladder cancer and previous bacillus Calmette-Guérin failure. Complete response remained durable at 1 year followup in this heavily pretreated patient population.

Original languageEnglish (US)
Pages (from-to)1633-1638
Number of pages6
JournalJournal of Urology
Volume192
Issue number6
DOIs
StatePublished - Dec 1 2014
Externally publishedYes

Keywords

  • intravesical administration
  • investigational
  • nanotechnology
  • paclitaxel
  • therapies
  • urinary bladder neoplasms

ASJC Scopus subject areas

  • Urology

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