title: BCG (RIVM) versus mitomycin intravesical therapy in superficial bladder cancer. First results of randomized prospective trial.
abstract: 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.
authors.affiliation: Department of Urology, University Hospital Nijmegen, The Netherlands.
authors.forename: F M
authors.initials: FM
authors.lastname: DeBruyne
authors.forename: A P
authors.initials: AP
authors.lastname: van der Meijden
authors.forename: A D
authors.initials: AD
authors.lastname: Geboers
authors.forename: M P
authors.initials: MP
authors.lastname: Franssen
authors.forename: M J
authors.initials: MJ
authors.lastname: van Leeuwen
authors.forename: P A
authors.initials: PA
authors.lastname: Steerenberg
authors.forename: W H
authors.initials: WH
authors.lastname: de Jong
authors.forename: J J
authors.initials: JJ
authors.lastname: Ruitenberg
mesh_terms: D000283:Administration, Intravesical; D001500:BCG Vaccine / Q000009:adverse effects / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000188:drug therapy*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D003556:Cystitis / Q000209:etiology; D004334:Drug Administration Schedule; D006801:Humans; D008937:Mitomycins / Q000009:adverse effects / Q000627:therapeutic use*; D009426:Netherlands; D011446:Prospective Studies; D011897:Random Allocation; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
chemical_list: D001500:BCG Vaccine; D008937:Mitomycins