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.

Abstract

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.

• Authors: J A Witjes, A P vd Meijden, W P Witjes, W Doesburg, H E Schaafsma, F M Debruyne
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 29A Issue 12 Pg. 1672-6 ( 1993) ISSN: 0959-8049 [Print] England
• PMID: 8398292 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• BCG Vaccine
• Mitomycin

Topics

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