title: Intravesical electromotive mitomycin C versus passive transport mitomycin C for high risk superficial bladder cancer: a prospective randomized study.
abstract: OBJECTIVE
  In laboratory studies electromotive mitomycin C (MMC) demonstrated markedly increased transport rates compared with passive transport. We performed a prospective study in patients with high risk superficial bladder cancer to assess the efficacy of intravesical electromotive vs passive MMC using bacillus Calmette-Guerin (BCG) as a comparative treatment.
  
  
  METHODS
  Following transurethral resection and multiple biopsies 108 patients with multifocal Tis, including 98 with T1 tumors, were randomized into 3 equal groups of 36 each who underwent 40 mg electromotive MMC instillation with 20 mA electric current for 30 minutes, 40 mg passive MMC with a dwell time of 60 minutes or 81 mg BCG with a dwell time of 120 minutes. Patients were scheduled for an initial 6 weekly treatments, a further 6 weekly treatments for nonresponders and a followup 10 monthly treatments for responders. Primary end points were the complete response rate at 3 and 6 months. MMC pharmacokinetics were assessed.
  
  
  RESULTS
  The complete response for electromotive vs passive MMC at 3 and 6 months was 53% versus 28% (p = 0.036) and 58% versus 31% (p = 0.012). For BCG the responses were 56% and 64%. Median time to recurrence was 35 vs 19.5 months (p = 0.013) and for BCG it was 26 months. Peak plasma MMC was significantly higher following electromotive MMC than after MMC (43 vs 8 ng/ml), consistent with bladder content absorption.
  
  
  CONCLUSIONS
  Intravesical electromotive administration increases bladder uptake of MMC, resulting in an improved response rate in cases of high risk superficial bladder cancer.
authors.affiliation: Departments of Urology and Clinical Biochemistry, Tor Vergata University, Via Torrice n. 4, 00189 Rome, Italy. sdistas@tin.it
authors.forename: Savino M
authors.initials: SM
authors.lastname: Di Stasi
authors.forename: Antonella
authors.initials: A
authors.lastname: Giannantoni
authors.forename: Robert L
authors.initials: RL
authors.lastname: Stephen
authors.forename: Giovanni
authors.initials: G
authors.lastname: Capelli
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Navarra
authors.forename: Renato
authors.initials: R
authors.lastname: Massoud
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Vespasiani
mesh_terms: D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000493:pharmacokinetics; D002278:Carcinoma in Situ / Q000188:drug therapy*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage* / Q000493:pharmacokinetics; D011446:Prospective Studies; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
chemical_list: D000903:Antibiotics, Antineoplastic; D016685:Mitomycin