A randomized study of short-versus long-term intravesical epirubicin instillation for superficial bladder cancer. Nagoya University Urological Oncology Group.
OBJECTIVE
A prospective randomized study was undertaken to determine whether prophylactic maintenance instillation of epirubicin following induction treatment is beneficial in patients with superficial bladder cancer.


METHODS
One hundred and forty-eight patients with resectable superficial bladder cancer (Ta-1, single, multiple, primary or recurrent with, however, no recurrence during the last year) were enrolled in this study. In both arms, epirubicin (40 mg/ml in normal saline) was administered six times within 4 weeks after a transurethral resection of the bladder tumor(s). In arm A, the patients received 11 additional monthly instillations of epirubicin.


RESULTS
Of the 148 patients, 138 (93.2%) were eligible and followed for an average of 29.6 months. 93 (67.4%) had a solitary tumor. No significant difference in the recurrence-free curve was observed between the two arms (p = 0.62). The recurrence rate per year was 0.16 in arm A and 0.17 in arm B. Toxicity included vesical irritability in 10 (7.2%) and hematuria in 1 patient. No significant difference in the frequency or degree of toxicity was observed between the two arms.


CONCLUSIONS
These data suggest that maintenance instillation of epirubicin does not reduce superficial bladder cancer recurrence.
Okamura
K
K
Department of Urology, Nagoya University School of Medicine, Japan.
Kinukawa
T
T
Tsumura
Y
Y
Otani
T
T
Itoh
H
H
Kobayashi
H
H
Matsuura
O
O
Kobayashi
M
M
Fukatsu
T
T
Ohshima
S
S
D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D011446:Prospective Studies; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
D000903:Antibiotics, Antineoplastic; D015251:Epirubicin