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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

2014; Lippincott Williams & Wilkins; Volume: 192; Issue: 6 Linguagem: Inglês

10.1016/j.juro.2014.06.084

1527-3792

James M. McKiernan, Dara Holder, Rashed Ghandour, LaMont Barlow, Jennifer Ahn, Max Kates, Gina M. Badalato, Arindam RoyChoudhury, G. Joel DeCastro, Mitchell C. Benson,

Infectious Disease Case Reports and Treatments

No AccessJournal of UrologyAdult Urology1 Dec 2014Phase 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, and Mitchell C. Benson James M. McKiernanJames M. McKiernan Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York , Dara D. HolderDara D. Holder Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York , Rashed A. GhandourRashed A. Ghandour Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York , LaMont J. BarlowLaMont J. Barlow Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York , Jennifer J. AhnJennifer J. Ahn Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York , Max KatesMax Kates Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York , Gina M. BadalatoGina M. Badalato Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York , Arindam RoychoudhuryArindam Roychoudhury Department of Biostatistics, Mailman School of Public Health, Columbia University Medical Center, New York, New York , G. Joel DecastroG. Joel Decastro Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York , and Mitchell C. BensonMitchell C. Benson Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York View All Author Informationhttps://doi.org/10.1016/j.juro.2014.06.084AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail 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. References 1 National Cancer Institute: SEER Stat Fact Sheets: Bladder Cancer, Statistics at a Glance, November 2013. Available at http://seer.cancer.gov/statfacts/html/urinb.html. Google Scholar 2 : Non-muscle-invasive bladder cancer (Ta, T1, and CIS). In: . Edited by . Philadelphia: Saunders2012: 2335. Google Scholar 3 : Long-term results and complications of intracavitary bacillus Calmette-Guerin therapy for bladder cancer. J Urol1984; 132: 457. 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Google Scholar © 2014 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited BySteinberg R, Thomas L, Brooks N, Mott S, Vitale A, Crump T, Rao M, Daniels M, Wang J, Nagaraju S, DeWolf W, Lamm D, Kates M, Hyndman M, Kamat A, Bivalacqua T, Nepple K and O'Donnell M (2019) Multi-Institution Evaluation of Sequential Gemcitabine and Docetaxel as Rescue Therapy for Nonmuscle Invasive Bladder CancerJournal of Urology, VOL. 203, NO. 5, (902-909), Online publication date: 1-May-2020.DeCastro G, Sui W, Pak J, Lee S, Holder D, Kates M, Virk R, Drake C, Anderson C, James B, Abate-Shen C and McKiernan J (2020) A Phase I Trial of Intravesical Cabazitaxel, Gemcitabine and Cisplatin for the Treatment of Nonmuscle Invasive bacillus Calmette-Guérin Unresponsive or Recurrent/Relapsing Urothelial Carcinoma of the BladderJournal of Urology, VOL. 204, NO. 2, (247-253), Online publication date: 1-Aug-2020.Chang S (2019) Re: Preclinical Evaluation of Intravesical Cisplatin Nanoparticles for Non-Muscle-Invasive Bladder CancerJournal of Urology, VOL. 201, NO. 5, (857-858), Online publication date: 1-May-2019.Chang S (2019) Re: Long-Term Survival Outcomes with Intravesical Nanoparticle Albumin-Bound Paclitaxel for Recurrent Non-Muscle-Invasive Bladder Cancer after Previous bacillus Calmette-Guérin TherapyJournal of Urology, VOL. 201, NO. 4, (665-665), Online publication date: 1-Apr-2019.Atala A (2016) Re: Reporter Nanoparticle that Monitors its Anticancer Efficacy in Real TimeJournal of Urology, VOL. 196, NO. 4, (1313-1314), Online publication date: 1-Oct-2016.Steers W (2014) This Month in Adult UrologyJournal of Urology, VOL. 192, NO. 6, (1589-1590), Online publication date: 1-Dec-2014.Nazmifar M, Williams C, Naser-Tavakolian A, Heard J, Rosser C, Theodorescu D and Ahdoot M Clinical and Preclinical Therapies for Bladder Cancer Following BCG FailureJournal of Urology, Volume 192Issue 6December 2014Page: 1633-1638 Advertisement Copyright & Permissions© 2014 by American Urological Association Education and Research, Inc.Keywordsnanotechnologypaclitaxelintravesical administrationurinary bladder neoplasmstherapiesinvestigationalAcknowledgmentsJiibril Palmer and Matthew Danzig provided assistance.MetricsAuthor Information James M. McKiernan Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York More articles by this author Dara D. Holder Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York More articles by this author Rashed A. Ghandour Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York More articles by this author LaMont J. Barlow Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York More articles by this author Jennifer J. Ahn Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York Financial interest and/or other relationship with Celgene. More articles by this author Max Kates Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York More articles by this author Gina M. Badalato Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York More articles by this author Arindam Roychoudhury Department of Biostatistics, Mailman School of Public Health, Columbia University Medical Center, New York, New York Financial interest and/or other relationship with Novartis. More articles by this author G. Joel Decastro Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York More articles by this author Mitchell C. Benson Department of Urology, Herbert Irving Cancer Center, Columbia University Medical Center, New York, New York More articles by this author Expand All Advertisement PDF DownloadLoading ...