A RANDOMIZED PROSPECTIVE-STUDY COMPARING INTRAVESICAL INSTILLATIONS OF MITOMYCIN-C, BCG-TICE, AND BCG-RIVM IN PTA-PT1 TUMORS AND PRIMARY-CARCINOMA IN-SITU OF THE URINARY-BLADDER
Ja. Witjes et al., A RANDOMIZED PROSPECTIVE-STUDY COMPARING INTRAVESICAL INSTILLATIONS OF MITOMYCIN-C, BCG-TICE, AND BCG-RIVM IN PTA-PT1 TUMORS AND PRIMARY-CARCINOMA IN-SITU OF THE URINARY-BLADDER, European journal of cancer, 29A(12), 1993, pp. 1672-1676
We compared intravesical instillations with mitomycin-C (MMC), Bacillu
s Calmette-Guerin (BCG) Tice, and BCG-RIVM in patients with pTa-pT1 pa
pillary 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 follo
w-up of 32 months (range 12-56). Drug-induced and bacterial cystitis w
ere the most frequent side-effects. The number and severity of side-ef
fects (chi2 test) were comparable in both BCG groups, but were signifi
cantly less in the MMC group for drug-induced cystitis (P = 0.009), ot
her local side-effects (P = 0.004) and systemic side-effects (P < 0.00
1). The disease-free percentage (log-rank test) showed no significant
difference for the three arms for papillary tumours (P = 0.08), nor th
e CIS (P = 0.20), although for CIS numbers are small. Additional insti
llations did not influence toxicity or efficacy.