Multicenter study on the use of gemcitabine to prevent recurrence of multiple-recurring superficial bladder tumors following intravesical antiblastic agents and/or BCG: Evaluation of tolerance

Francesco Morabito, Riccardo Rossi, Manuela Efrem Graziano, Ugo Ferrando, Vanessa Lancini, Emidio Cretarola, Giario Conti, Anna Chiara Luporini, Giovanni Muto, Emanuele Castelli, Leonardo D'Urso, Pasquale Razionale, Giuseppe Lissoni, Maurizio Simone, Francesco Francesca, Monica Sommariva, Marilena Casu, Rodolfo Hurle

Research output: Contribution to journalArticle

Abstract

Objectives: The treatment of choice for superficial bladder TCC is endoscopic resection, followed or not by intravesical immuno/chemotherapy. Some patients are not responders to common intravesical therapy and are more exposed to disease progression. In this case the suitable treatment is radical cystectomy. Because gemcitabine is effective against advanced bladder cancer, we have initiated a study to evaluate the efficacy of its intravesical use to prevent relapse and disease progression, and tolerance and safety of this drug in patients with multi-treated bladders. In this preliminary study, we cite only data on tolerance. Materials and Methods: 64 patients were selected, and 61 were evaluable (age range 39-84 years), with multiple-recurrent bladder TCC. All patients were previously treated with intravesical chemotherapy and/or immunotherapy. The protocol provided for intravesical instillation of gemcitabine (2000 mg) once per week for 8 weeks. We collected data regarding problems noted by the patients (both local and systemic). Results: 53 patients out of 61 (86.9%) completed the cycle. Side effects appeared in 14 patients, 8 of these had to suspend the treatment. Severe side effects were systemic in 4 patients (1 systemic edema, 1 malaise and dysgeusia, 1 hyperthermia and severe strangury, 1 elevated transaminases and asthenia), and local in 4 patients (1 severe urinary urgency, 1 hematuria, 1 urinary incontinence, and 1 case of pelvic pain). In 6 patients we observed pelvic pain, hematuria, strangury and UTI of medium magnitude that did not require treatment interruption. Conclusions: We believe that the severe side effects requiring treatment interruption are attributable primarily to increased sensitivity in patients with multi-treated bladders. In our experience, the side effects responsible for suspension occurred at the start of treatment in 7 cases out of 8. Our study demonstrates the safety of intravesical gemcitabine in patients with recurrent and multi-treated superficial TCC of the bladder.

Original languageEnglish
Pages (from-to)1-4
Number of pages4
JournalArchivio Italiano di Urologia e Andrologia
Volume78
Issue number1
Publication statusPublished - Mar 2006

Keywords

  • Bladder cancer
  • Gemcitabine
  • Intravesical chemotheraphy/immunotherapy
  • Side effects
  • Tolerance

ASJC Scopus subject areas

  • Nephrology
  • Urology

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    Morabito, F., Rossi, R., Graziano, M. E., Ferrando, U., Lancini, V., Cretarola, E., Conti, G., Luporini, A. C., Muto, G., Castelli, E., D'Urso, L., Razionale, P., Lissoni, G., Simone, M., Francesca, F., Sommariva, M., Casu, M., & Hurle, R. (2006). Multicenter study on the use of gemcitabine to prevent recurrence of multiple-recurring superficial bladder tumors following intravesical antiblastic agents and/or BCG: Evaluation of tolerance. Archivio Italiano di Urologia e Andrologia, 78(1), 1-4.