TY - JOUR
T1 - Multicenter study on the use of gemcitabine to prevent recurrence of multiple-recurring superficial bladder tumors following intravesical antiblastic agents and/or BCG
T2 - Evaluation of tolerance
AU - Morabito, Francesco
AU - Rossi, Riccardo
AU - Graziano, Manuela Efrem
AU - Ferrando, Ugo
AU - Lancini, Vanessa
AU - Cretarola, Emidio
AU - Conti, Giario
AU - Luporini, Anna Chiara
AU - Muto, Giovanni
AU - Castelli, Emanuele
AU - D'Urso, Leonardo
AU - Razionale, Pasquale
AU - Lissoni, Giuseppe
AU - Simone, Maurizio
AU - Francesca, Francesco
AU - Sommariva, Monica
AU - Casu, Marilena
AU - Hurle, Rodolfo
PY - 2006/3
Y1 - 2006/3
N2 - 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.
AB - 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.
KW - Bladder cancer
KW - Gemcitabine
KW - Intravesical chemotheraphy/immunotherapy
KW - Side effects
KW - Tolerance
UR - http://www.scopus.com/inward/record.url?scp=33646709189&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33646709189&partnerID=8YFLogxK
M3 - Article
C2 - 16752879
AN - SCOPUS:33646709189
VL - 78
SP - 1
EP - 4
JO - Archivio Italiano di Urologia Nefrologia Andrologia
JF - Archivio Italiano di Urologia Nefrologia Andrologia
SN - 1120-8538
IS - 1
ER -