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document
BCG ( RIVM ) versus mitomycin intravesical therapy in superficial bladder cancer . First results of randomized prospective trial . 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 .
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Intervention_Pharmacological
BCG ( RIVM )
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Intervention_Pharmacological
mitomycin intravesical therapy
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Outcome_Adverse-effects
incidence of side effects
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Outcome_Physical
recurrence rate of tumors
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Outcome_Physical
Drug-induced , or chemical cystitis
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Outcome_Physical
bacterial cystitis
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Outcome_Physical
recurrent tumors
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Participant_Condition
bladder cancer