BCG (RIVM) versus mitomycin intravesical therapy in superficial bladder cancer. First results of randomized prospective trial

Urology. 1988 Mar;31(3 Suppl):20-5.


This study presents the preliminary results of a randomized prospective two-arm study in which bacillus Calmette-Guérin (BCG) RIVM, a Dutch BCG preparation, is compared with mitomycin C (MMC) in patients with primary or recurrent superficial bladder tumors, including carcinoma in situ (CIS). Therapeutic regimens were as follows: after complete transurethral resection of all visible tumors, BCG RIVM (1 x 10(9) bacilli in 50 mL saline) was instilled once a week for six consecutive weeks, and mitomycin C (30 mg in 50 mL saline) was administered once a week for one month (weeks 1 to 4) and thereafter once a month for a total of six months. Reported are the incidence of side effects in 165 patients and the recurrence rate of tumors in 308 patients after a follow-up period of twelve months. Drug-induced, or chemical cystitis was observed in 13 (16.7%) of 78 BCG-treated patients and in 12 (13.8%) of 87 MMC-treated patients. In the same groups bacterial cystitis occurred in 17 (21.8%) patients and in 16 (18.4%) patients, respectively. In the BCG-treated group (N = 148), 44 (29.8%) had recurrent tumors, while in the MMC-treated group (N = 160), 40 (25.0%) had a recurrence. The recurrence rate for BCG-treated patients was 0.33; the recurrence rate for MMC-treated patients was 0.29 (P = 0.560, not significant). These preliminary data demonstrated no statistically significant difference between the two arms with regard to toxicity and recurrence of tumors.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Intravesical
  • BCG Vaccine / adverse effects
  • BCG Vaccine / therapeutic use*
  • Carcinoma in Situ / drug therapy*
  • Carcinoma, Transitional Cell / drug therapy*
  • Clinical Trials as Topic
  • Cystitis / etiology
  • Drug Administration Schedule
  • Humans
  • Mitomycins / adverse effects
  • Mitomycins / therapeutic use*
  • Netherlands
  • Prospective Studies
  • Random Allocation
  • Urinary Bladder Neoplasms / drug therapy*


  • BCG Vaccine
  • Mitomycins