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

Melissa A. Laudano, Lamont J. Barlow, Alana M. Murphy, Daniel P. Petrylak, Manisha Desai, Mitchell C. Benson, James M. McKiernan

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)134-137
Number of pages4
JournalUrology
Volume75
Issue number1
DOIs
StatePublished - Jan 1 2010
Externally publishedYes

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docetaxel
Urinary Bladder Neoplasms
Cystoscopy
Therapeutics
Cell Biology
Tomography
Intravesical Administration
Biopsy
Recurrence
Transitional Cell Carcinoma
Mycobacterium bovis
Treatment Failure
Disease-Free Survival

ASJC Scopus subject areas

  • Urology

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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. / Laudano, Melissa A.; Barlow, Lamont J.; Murphy, Alana M.; Petrylak, Daniel P.; Desai, Manisha; Benson, Mitchell C.; McKiernan, James M.

In: Urology, Vol. 75, No. 1, 01.01.2010, p. 134-137.

Research output: Contribution to journalArticle

Laudano, Melissa A. ; Barlow, Lamont J. ; Murphy, Alana M. ; Petrylak, Daniel P. ; Desai, Manisha ; Benson, Mitchell C. ; McKiernan, James M. / 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. In: Urology. 2010 ; Vol. 75, No. 1. pp. 134-137.
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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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