title: Results of long-term follow-up of patients with superficial bladder carcinoma treated with intravesically applied bacillus Calmette-Guerin vaccine according to the schedule of 6 weekly + 6 monthly instillations.
abstract: BACKGROUND
  The efficacy of bacillus Calmette-Guerin (BCG) immunotherapy in the prevention of local recurrence and disease progression in patients with superficial bladder cancer is very well documented. This study reports the effect of BCG on disease-specific and overall survival.
  
  
  METHODS
  In this retrospective trial, we have analyzed 170 patients with stage Ta and T1 superficial bladder cancer. Patients in the control group (87 patients) we followed-up only (median follow-up of 119 months) and treated surgically or with other oncologic modalities when progression of disease was diagnosed. The BCG group consisted of 83 patients treated with 6 weekly followed by 6 monthly instillations, and they have been followed-up of median 124 months.
  
  
  RESULTS
  Patients receiving BCG had statistically significant better 10-year disease specific survival (83% vs. 69%, P = 0.03). At the same time point, the local recurrence rate was 48 % and the progression rate 19% for patients treated with BCG, while 77% (P < 0.001) and 38% (P = 0.007) were results in control group. Despite numerically better in the BCG group, overall survival is not significantly different in the 2 groups (P = 0.14).
  
  
  CONCLUSIONS
  BCG immunotherapy significantly increases the disease-specific survival in patients with superficial bladder carcinoma.
authors.affiliation: Department of Urology, University of Split, School of Medicine, Split, Croatia. davor.librenjak@krizine.kbsplit.hr
authors.forename: Davor
authors.initials: D
authors.lastname: Librenjak
authors.forename: Marijan
authors.initials: M
authors.lastname: Situm
authors.forename: Eduard
authors.initials: E
authors.lastname: Vrdoljak
authors.forename: Kazimir
authors.initials: K
authors.lastname: Milostić
authors.forename: Josip
authors.initials: J
authors.lastname: Gotovac
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000627:therapeutic use*; D002277:Carcinoma / Q000628:therapy*; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012189:Retrospective Studies; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000628:therapy*
chemical_list: D001500:BCG Vaccine