title: Intravesical 4'-epi-doxorubicin (epirubicin) versus bacillus Calmette-Guérin. A controlled prospective study on the prophylaxis of superficial bladder cancer.
abstract: BACKGROUND
  The selection of the most appropriate antineoplastic agent and optimal treatment schedule for the prophylaxis of superficial bladder cancer against tumor recurrences is the subject of continual investigations.
  
  
  METHODS
  A controlled prospective trial involving 161 patients evaluated and compared the efficacy of intravesical epirubicin and bacillus Calmette-Guérin (BCG) administration as prophylaxis against recurrences after complete transurethral resection of superficial bladder cancer. The treatment schedule, consisting of one 6- or 8-week course of instillations (50 mg epirubicin or 150 mg BCG per instillation) followed by single maintenance doses to the responders at follow-up examinations, was modified for those of the initial responders who were at high risk for recurrence and who received an additional separate 4-week course of treatment 6 months after the start of therapy.
  
  
  RESULTS
  Sixty percent of the patients treated with epirubicin, 68% of the patients treated with BCG, and 41% of the control subjects, who underwent resection only, remained free of recurrences for a mean follow-up of 32.9 months. The only significant difference was found between patients treated with BCG and control subjects, in favor of the former. Conversely, recurrence rate per 100 patient-months and mean interval to recurrence showed both drugs to be superior to resection alone regarding several tumor characteristics. However, a significant benefit in favor of BCG when compared with epirubicin was shown in those patients who had Stage T1 and Grade 3 tumors at presentation.
  
  
  CONCLUSIONS
  Intravesical epirubicin and BCG were superior to transurethral resection alone in the prophylaxis of superficial bladder cancer, but with respect to superficially invasive and high-grade tumors, BCG demonstrated a remarkable advantage.
authors.affiliation: Department of Urology, University Hospital of Rio (Patras), Greece.
authors.forename: M D
authors.initials: MD
authors.lastname: Melekos
authors.forename: H S
authors.initials: HS
authors.lastname: Chionis
authors.forename: G S
authors.initials: GS
authors.lastname: Paranychianakis
authors.forename: H H
authors.initials: HH
authors.lastname: Dauaher
mesh_terms: D000283:Administration, Intravesical; D000368:Aged; D001500:BCG Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000517:prevention & control / Q000601:surgery; D002295:Carcinoma, Transitional Cell / Q000517:prevention & control* / Q000601:surgery; D003131:Combined Modality Therapy; D003556:Cystitis / Q000139:chemically induced / Q000209:etiology; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D009367:Neoplasm Staging; D011446:Prospective Studies; D012074:Remission Induction; D001749:Urinary Bladder Neoplasms / Q000517:prevention & control* / Q000601:surgery
chemical_list: D001500:BCG Vaccine; D015251:Epirubicin