title: Intravesical BCG in patients with carcinoma in situ of the urinary bladder: long-term results of EORTC GU Group phase II protocol 30861.
abstract: OBJECTIVE
  This phase II study was designed to assess the response rate, side effects and long-term efficacy of BCG in the treatment of carcinoma in situ (Cis) of the urinary bladder.
  
  
  METHODS
  103 eligible patients with Cis were treated with 6 consecutive weekly intravesical instillations of 120 mg BCG-Connaught. In case of no response, a second 6-week course was given.
  
  
  RESULTS
  A complete response (CR) was observed in 77 of the 103 eligible patients (75%) and 93 evaluable patients (83%). In 6 of 10 patients the CR was induced by a second cycle of 6 weekly instillations. After a median follow-up of 7.6 years, 39 of the 77 CR patients (50%) are still alive and have retained their bladder, 31 (40%) without tumor recurrence. Another 7 patients underwent cystectomy and are still alive while 16 (20%) have died due to bladder cancer. Ten patients stopped treatment due to toxicity. In 2 patients, cystectomy was done because of severe cystitis and reduced bladder capacity. Drug cystitis, bacterial cystitis and fever occurred in 45, 15 and 15% of the patients, respectively. Severe drug cystitis was noted in 3 out of 10 patients receiving more than 6 instillations, necessitating cystectomy in 1 case.
  
  
  CONCLUSIONS
  Intravesical short-term BCG is an effective treatment modality in Cis, yielding a high CR rate. This therapy may however be suboptimal in some patients as the 5-year disease-free rate in complete responders drops to 60%. Still, this is an acceptable result for patients in whom cystectomy would otherwise be performed in virtually all cases.
authors.affiliation: Department of Urology, RWTH Aachen, Germany. gjakse@post.klinikum.rwth-aachen.de
authors.forename: G
authors.initials: G
authors.lastname: Jakse
authors.forename: R
authors.initials: R
authors.lastname: Hall
authors.forename: A
authors.initials: A
authors.lastname: Bono
authors.forename: W
authors.initials: W
authors.lastname: Höltl
authors.forename: P
authors.initials: P
authors.lastname: Carpentier
authors.forename: J P
authors.initials: JP
authors.lastname: Spaander
authors.forename: A P
authors.initials: AP
authors.lastname: van der Meijden
authors.forename: R
authors.initials: R
authors.lastname: Sylvester
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000008:administration & dosage*; D002278:Carcinoma in Situ / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine