A randomized study of short-versus long-term intravesical epirubicin instillation for superficial bladder cancer. Nagoya University Urological Oncology Group.

Abstract

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.

PATIENTS AND 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.

CONCLUSION:

These data suggest that maintenance instillation of epirubicin does not reduce superficial bladder cancer recurrence.

• Authors: K Okamura, T Kinukawa, Y Tsumura, T Otani, H Itoh, H Kobayashi, O Matsuura, M Kobayashi, T Fukatsu, S Ohshima
• Journal: European urology (Eur Urol) Vol. 33 Issue 3 Pg. 285-8; discussion 289 ( 1998) ISSN: 0302-2838 [Print] Switzerland
• PMID: 9555553 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Antibiotics, Antineoplastic
• Epirubicin

Topics

• Administration, Intravesical
• Adult
• Aged
• Aged, 80 and over
• Antibiotics, Antineoplastic (administration & dosage, adverse effects)
• Drug Administration Schedule
• Epirubicin (administration & dosage, adverse effects)
• Female
• Humans
• Male
• Middle Aged
• Neoplasm Recurrence, Local (prevention & control)
• Prospective Studies
• Urinary Bladder Neoplasms (drug therapy)