title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: S C Urologia 3 D O Ospedale Molinette, Torino, Italy. dafamor@virgilio.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Morabito
authors.forename: Riccardo
authors.initials: R
authors.lastname: Rossi
authors.forename: Manuela Efrem
authors.initials: ME
authors.lastname: Graziano
authors.forename: Ugo
authors.initials: U
authors.lastname: Ferrando
authors.forename: Vanessa
authors.initials: V
authors.lastname: Lancini
authors.forename: Emidio
authors.initials: E
authors.lastname: Cretarola
authors.forename: Giario
authors.initials: G
authors.lastname: Conti
authors.forename: Anna Chiara
authors.initials: AC
authors.lastname: Luporini
authors.forename: Giovanni
authors.initials: G
authors.lastname: Muto
authors.forename: Emanuele
authors.initials: E
authors.lastname: Castelli
authors.forename: Leonardo
authors.initials: L
authors.lastname: D'Urso
authors.forename: Pasquale
authors.initials: P
authors.lastname: Razionale
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lissoni
authors.forename: Maurizio
authors.initials: M
authors.lastname: Simone
authors.forename: Francesco
authors.initials: F
authors.lastname: Francesca
authors.forename: Monica
authors.initials: M
authors.lastname: Sommariva
authors.forename: Marilena
authors.initials: M
authors.lastname: Casu
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Hurle
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000517:prevention & control*; D000093542:Gemcitabine
chemical_list: D000276:Adjuvants, Immunologic; D000970:Antineoplastic Agents; D001500:BCG Vaccine; D003841:Deoxycytidine; D000093542:Gemcitabine