[A randomized controlled study to compare bladder instillation therapy of anticancer agents and combination therapy with OK-432 injection in prevention of post-TUR recurrence of bladder cancer]

Hinyokika Kiyo. 1988 Nov;34(11):2053-7.
[Article in Japanese]


To evaluate the effects of bladder instillation chemotherapy of anticancer agents with OK-432 intradermal injection (group A) in preventing postoperative recurrence of bladder carcinoma, a randomized controlled study with intravesical instillation chemotherapy of anticancer agents (group B) as the reference standard was performed. As the anticancer agents, pepleomycin (PEP) was usually used at a concentration of 30 mg/30 ml physiological saline. OK-432 injection dose was gradually increased from 0.5 KE to 5.0 KE and maintenance dose was decided by local skin reactions. There were no differences in the patient's background factors between group A (22 cases) and group B (17 cases). The no-recurrence rate of bladder carcinoma was similar in the two groups, but the no-recurrence rate for the virgin tumor or the stage T0 cases was higher in group B. On the other hand, the values for the recurrent cases or the stage T1,2 cases was higher in group A. The SU-PS skin reaction as an immunological response was significantly higher in group A. There were no severe side effects derived from anticancer bladder instillation or OK-432 injection.

Publication types

  • Clinical Trial
  • Comparative Study
  • English Abstract
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Intravesical
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Biological Products / administration & dosage*
  • Bleomycin / administration & dosage
  • Bleomycin / therapeutic use*
  • Female
  • Humans
  • Injections, Intradermal
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Neoplasm Recurrence, Local / pathology
  • Neoplasm Recurrence, Local / prevention & control*
  • Neoplasm Staging
  • Peplomycin
  • Picibanil / administration & dosage*
  • Postoperative Complications / prevention & control*
  • Random Allocation
  • Urinary Bladder Neoplasms / pathology
  • Urinary Bladder Neoplasms / prevention & control*
  • Urinary Bladder Neoplasms / surgery


  • Biological Products
  • Bleomycin
  • Picibanil
  • Peplomycin