A randomised prospective study comparing intravesical instillations of mitomycin-C, BCG-Tice, and BCG-RIVM in pTa-pT1 tumours and primary carcinoma in situ of the urinary bladder. Dutch South-East Cooperative Urological Group

Eur J Cancer. 1993;29A(12):1672-6. doi: 10.1016/0959-8049(93)90102-l.


We compared intravesical instillations with mitomycin-C (MMC), Bacillus Calmette-Guerin (BCG) Tice, and BCG-RIVM in patients with pTa-pT1 papillary carcinoma and primary carcinoma in situ (CIS) of the bladder. Nine instillations with MMC were given or 6 weekly instillations with BCG. Early recurrences were treated with additional instillations. For toxicity and efficacy 437 patients were evaluated with a median follow-up of 32 months (range 12-56). Drug-induced and bacterial cystitis were the most frequent side-effects. The number and severity of side-effects (chi 2 test) were comparable in both BCG groups, but were significantly less in the MMC group for drug-induced cystitis (P = 0.009), other local side-effects (P = 0.004) and systemic side-effects (P < 0.001). The disease-free percentage (log-rank test) showed no significant difference for the three arms for papillary tumours (P = 0.08), nor the CIS (P = 0.20), although for CIS numbers are small. Additional instillations did not influence toxicity or efficacy.

Publication types

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

MeSH terms

  • Administration, Intravesical
  • Aged
  • BCG Vaccine / therapeutic use*
  • Carcinoma in Situ / pathology
  • Carcinoma in Situ / therapy*
  • Carcinoma, Transitional Cell / pathology
  • Carcinoma, Transitional Cell / therapy*
  • Cystitis / complications
  • Female
  • Humans
  • Male
  • Mitomycin / therapeutic use*
  • Neoplasm Staging
  • Prospective Studies
  • Urinary Bladder Neoplasms / therapy*


  • BCG Vaccine
  • Mitomycin