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      Long-term Clinical Outcomes of a Phase I Trial of Intravesical Docetaxel in the Management of Non–muscle-invasive Bladder Cancer Refractory to Standard Intravesical Therapy

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          Abstract

          OBJECTIVES

          To report the long-term clinical outcomes and durability of response after treatment with induction intravesical docetaxel. Most novel agents used to treat bacillus Calmette-Guerin refractory high-grade non–muscle-invasive (NMI) bladder cancer are evaluated only after short follow-up periods. Our previously published phase I trial demonstrated that docetaxel is a safe agent for intravesical therapy with minimal toxicity and no detectable systemic absorption. We sought to determine long-term clinical outcomes after treatment with intravesical docetaxel.

          METHODS

          Eighteen patients with recurrent Ta (n = 7), T1 (n = 5), and Tis (n = 6) transitional cell carcinoma who experienced treatment failure with at least 1 prior intravesical therapy completed the phase I trial. Docetaxel was administered as 6 weekly intravesical instillations using a dose-escalation model terminated at 0.75 mg/mL. Efficacy was evaluated by interval cystoscopy with biopsies when indicated, cytology, and computed tomography imaging. Follow-up consisted of quarterly cystoscopy, cytology, computed tomography, and biopsy when indicated.

          RESULTS

          With a median follow-up of 48.3 months, 4 patients (22%) have demonstrated a complete durable response and currently remain disease-free without further treatment. Three patients (17%) had a partial response, defined as a single NMI recurrence with no further therapy for bladder cancer. Eleven patients (61%) failed treatment, and required another intervention. One patient developed stage progression. No delayed toxicities were noted. The median disease-free survival time was 13.3 months.

          CONCLUSIONS

          After 4 years of follow-up without maintenance therapy, intravesical docetaxel has demonstrated the ability to prevent recurrence in a select number of patients with refractory NMI bladder cancer and warrants further investigation.

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          Author and article information

          Journal
          0366151
          7907
          Urology
          Urology
          Urology
          0090-4295
          1527-9995
          13 May 2017
          13 November 2009
          January 2010
          13 July 2017
          : 75
          : 1
          : 134-137
          Affiliations
          Departments of Urology, and Medical Oncology, Columbia University Medical Center, New York, New York; and Department of Biostatistics, Mailman School of Public Health – Columbia University, New York, New York
          Author notes
          Reprint requests: Melissa A. Laudano, 161 Fort Washington Ave, HIP 11th Floor, New York, NY 10032. Melissa.laudano@ 123456gmail.com
          Article
          PMC5508734 PMC5508734 5508734 nihpa637363
          10.1016/j.urology.2009.06.112
          5508734
          19913890
          Categories
          Article

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