title: Intravesical gemcitabine therapy for superficial transitional cell carcinoma: results of a Phase II prospective multicenter study.
abstract: OBJECTIVE
  To determine the tolerability and efficacy after 1 year of weekly intravesical gemcitabine therapy in patients with intermediate-risk and high-risk superficial transitional cell carcinoma.
  
  
  METHODS
  A total of 116 patients with intermediate-risk and high-risk bladder cancer who had undergone transurethral resection were treated with one cycle (once a week for 6 weeks) of gemcitabine 2000 mg. Local and systemic tolerability and efficacy were evaluated.
  
  
  RESULTS
  In terms of the tolerability of gemcitabine, 14 patients (12.0%) reported urgency, 6 (5.1%) dizziness and slight fever (less than 38 degrees C), 1 (0.8%) severe abdominal pain, with ulcerative lesions of the bladder mucosa at cystoscopy, and 1 (0.8%) parosmia. The remaining 94 patients (81.3%) did not report any local side effects during the treatment period. In terms of efficacy, recurrence developed in 29 patients (25.4%) a mean of 7 months after transurethral resection; 85 patients (74.6%) were disease free after 12 months. The univariate analysis showed a greater level of efficacy in patients with a first occurrence (P = 0.0408), patients who had had no previous treatment (P = 0.0368), and patients with Stage pTa superficial transitional cell carcinoma (P = 0.0018). The multivariate analysis did not reveal any significant data. No significant differences were found between the intermediate-risk and high-risk patients in tolerability or efficacy. No recurrence developed in 18 (75%) of 24 intermediate-risk bacille Calmette-Guérin-refractory or 7 (43.7%) of 16 high-risk bacille Calmette-Guérin-refractory patients.
  
  
  CONCLUSIONS
  The results of our study have confirmed the good tolerability and 1 year efficacy of intravesical gemcitabine. The treatment schedule proposed resulted in high patient compliance, and the results can be compared with the results of studies using other intravesical treatments.
authors.affiliation: Department of Urology, University of Florence, Florence, Italy. bartoletti@unifi.it
authors.forename: Riccardo
authors.initials: R
authors.lastname: Bartoletti
authors.forename: Tommaso
authors.initials: T
authors.lastname: Cai
authors.forename: Mauro
authors.initials: M
authors.lastname: Gacci
authors.forename: Gianluca
authors.initials: G
authors.lastname: Giubilei
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Viggiani
authors.forename: Giorgio
authors.initials: G
authors.lastname: Santelli
authors.forename: Fabio
authors.initials: F
authors.lastname: Repetti
authors.forename: Stefano
authors.initials: S
authors.lastname: Nerozzi
authors.forename: Paolo
authors.initials: P
authors.lastname: Ghezzi
authors.forename: Michele
authors.initials: M
authors.lastname: Sisani
mesh_terms: D000283:Administration, Intravesical; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine