title: A randomized trial of early intravesical instillation of epirubicin in superficial bladder cancer. The Nagoya University Urological Oncology Group.
abstract: A total of 135 patients with superficial bladder cancer diagnosed as totally resectable were entered into a randomized multicenter trial to investigate the efficacy of early intravesical epirubicin instillation after resection in comparison with transurethral resection (TUR) alone. Epirubicin (40 mg/40 ml saline) was given within 24 h of TUR and once during the 1st week, weekly for 4 weeks and then monthly for 11 months. In all, 122 patients (90.4%) were eligible and 119 (88.1%) were evaluable. The interval to initial recurrence was significantly longer (P = 0.02) in the epirubicin group (36 months; 95% confidence interval, 32-40 months) than in the group receiving TUR alone (28 months; 95% confidence interval, 24-32 months). The recurrence rate per year in the epirubicin group was less than that in the TUR-alone group (0.13 versus 0.29 annual recurrences). Disease progression was observed in only one patient in the epirubicin-instillation group. The main toxicity encountered was bladder irritation (13.8%). These results demonstrate that early intravesical epirubicin instillation is efficacious in preventing local recurrence.
authors.affiliation: Department of Urology, Nagoya University School of Medicine, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Okamura
authors.forename: T
authors.initials: T
authors.lastname: Murase
authors.forename: K
authors.initials: K
authors.lastname: Obata
authors.forename: S
authors.initials: S
authors.lastname: Ohshima
authors.forename: Y
authors.initials: Y
authors.lastname: Ono
authors.forename: T
authors.initials: T
authors.lastname: Sakata
authors.forename: Y
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: T
authors.initials: T
authors.lastname: Shimoji
authors.forename: K
authors.initials: K
authors.lastname: Miyake
mesh_terms: D000283:Administration, Intravesical; D000368:Aged; D000369:Aged, 80 and over; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003558:Cystoscopy; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000601:surgery
chemical_list: D015251:Epirubicin