A prospective European Organization for Research and Treatment of Cancer Genitourinary Group randomized trial comparing transurethral resection followed by a single intravesical instillation of epirubicin or water in single stage Ta, T1 papillary carcinoma of the bladder.
A total of 431 eligible patients with solitary, primary or recurrent stages Ta and T1 transitional cell carcinoma of the bladder was included in a randomized multicenter trial to compare a single intravesical instillation of 80 mg. epirubicin with water given immediately after resection, with respect to the disease-free interval and recurrence rate. The interval to initial recurrence was significantly better in favor of the epirubicin group. After a mean followup of 2 years it became evident that the recurrence rate after a single epirubicin instillation was decreased by nearly half with the same trend being found in all subgroups examined. Toxicity was mainly restricted to bladder irritation in plus or minus 10% of the cases. Pathology review brought considerable changes in T category from stages T1 to Ta (53%). Changes in grade were less pronounced but nevertheless important.
Oosterlinck
W
W
Department of Urology, University Hospital, Gent, Belgium.
Kurth
K H
KH
Schröder
F
F
Bultinck
J
J
Hammond
B
B
Sylvester
R
R
D000283:Administration, Intravesical; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000453:epidemiology / Q000601:surgery; D003131:Combined Modality Therapy; D015251:Epirubicin / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D011446:Prospective Studies; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000601:surgery; D014867:Water
D014867:Water; D015251:Epirubicin