title: Long-term follow-up of an EORTC randomized prospective trial comparing intravesical bacille Calmette-Guérin-RIVM and mitomycin C in superficial bladder cancer. EORTC GU Group and the Dutch South East Cooperative Urological Group. European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Collaborative Group.
abstract: OBJECTIVE
  To determine long-term efficacy of intravesical mitomycin C (MMC) versus bacille Calmette-Guérin (BCG) in patients with superficial bladder cancer with regard to recurrences and progression.
  
  
  METHODS
  Patients with superficial bladder cancer (pTa, pT1, pTis) were treated with intravesical MMC (30 mg, weekly for 4 weeks, and thereafter monthly for 5 months) or BCG (weekly for 6 weeks).
  
  
  RESULTS
  Three hundred forty-four patients were eligible (171 in the BCG group, 173 in the MMC group). The median follow-up was 7.2 years. Toxicity was not significantly different between the two treatment groups. Efficacy of the two treatment policies was similar with regard to tumor recurrence. With regard to progression to invasive disease, MMC was more effective than BCG in patients without carcinoma in situ (CIS) (P = 0.006).
  
  
  CONCLUSIONS
  We can confirm the conclusions of other studies that intravesical treatment with 30 mg of MMC remains an effective treatment option that can also be used in high-risk patients. Like others, we could not confirm that a 6-week course of BCG is more effective in the prevention of tumor progression. Of the 33 patients with tumor progression after intravesical therapy, 20 died of bladder cancer, confirming that tumor progression after intravesical therapy carries a poor prognosis. In this study the difference in toxicity between BCG and MMC was not significant. When comparing studies with MMC and BCG, differences in treatment schedule and/or patient selection should be kept in mind.
authors.affiliation: Department of Urology, University Hospital, Nijmegen, The Netherlands.
authors.forename: J A
authors.initials: JA
authors.lastname: Witjes
authors.forename: A P
authors.initials: AP
authors.lastname: v d Meijden
authors.forename: L
authors.initials: L
authors.lastname: Collette
authors.forename: R
authors.initials: R
authors.lastname: Sylvester
authors.forename: F M
authors.initials: FM
authors.lastname: Debruyne
authors.forename: A
authors.initials: A
authors.lastname: van Aubel
authors.forename: W P
authors.initials: WP
authors.lastname: Witjes
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000283:Administration, Intravesical; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D001500:BCG Vaccine / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage*; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
chemical_list: D000276:Adjuvants, Immunologic; D000903:Antibiotics, Antineoplastic; D001500:BCG Vaccine; D016685:Mitomycin