title: Can early single dose instillation of epirubicin improve bacillus Calmette-Guerin efficacy in patients with nonmuscle invasive high risk bladder cancer? Results from a prospective, randomized, double-blind controlled study.
abstract: OBJECTIVE
  We evaluated the impact of epirubicin perioperative instillation in improving subsequent bacillus Calmette-Guerin instillation efficacy in high risk patients with nonmuscle invasive bladder cancer.
  
  
  METHODS
  Between January 2005 and June 2007, 161 patients affected by high risk nonmuscle invasive bladder cancer were enrolled in this prospective, randomized, controlled, double-blind study. A total of 80 patients were assigned to group A (perioperative epirubicin 80 mg/50 ml normal saline) plus delayed bacillus Calmette-Guerin instillations (5 x 108 colony-forming units in 50 ml saline) and 81 to group B (delayed bacillus Calmette-Guerin alone). The main outcome measures were time to first recurrence and recurrence rate. All data obtained from a median followup of 15.3 months in group A and 14.8 months in group B, were analyzed.
  
  
  RESULTS
  At the end of followup 46 of 80 patients in group A (57.5%) had no evidence of disease, just like 41 of 81 in group B (50.6%). No statistical difference was observed between the 2 groups in terms of recurrence rate (p = 0.82) or time to first recurrence (p = 0.095). Kaplan-Meier analysis of recurrence showed no significant differences between group A and group B (p = 0.0952). On multivariate analysis the early single dose instillation of epirubicin was not indicated as an independent prognostic factor (HR 0.50, 95% CI 0.32-1.18).
  
  
  CONCLUSIONS
  The present study showed no statistically significant differences in terms of disease-free time and recurrence rate between high risk patients with nonmuscle invasive bladder cancer who had undergone perioperative epirubicin instillation plus delayed bacillus Calmette-Guerin and those who had undergone delayed bacillus Calmette-Guerin alone.
authors.affiliation: Department of Urology, University of Florence, Florence, Italy. ktommy@libero.it
authors.forename: Tommaso
authors.initials: T
authors.lastname: Cai
authors.forename: Gabriella
authors.initials: G
authors.lastname: Nesi
authors.forename: Galliano
authors.initials: G
authors.lastname: Tinacci
authors.forename: Enzo
authors.initials: E
authors.lastname: Zini
authors.forename: Nicola
authors.initials: N
authors.lastname: Mondaini
authors.forename: Vieri
authors.initials: V
authors.lastname: Boddi
authors.forename: Sandra
authors.initials: S
authors.lastname: Mazzoli
authors.forename: Riccardo
authors.initials: R
authors.lastname: Bartoletti
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000283:Administration, Intravesical; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D001500:BCG Vaccine / Q000627:therapeutic use*; D004311:Double-Blind Method; D004357:Drug Synergism; D015251:Epirubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D011446:Prospective Studies; D012307:Risk Factors; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000276:Adjuvants, Immunologic; D000903:Antibiotics, Antineoplastic; D001500:BCG Vaccine; D015251:Epirubicin