title: Efficacy and tolerance of one-third full dose bacillus Calmette-Guérin maintenance therapy every 3 months or 6 months: two-year results of URO-BCG-4 multicenter study.
abstract: OBJECTIVE
  To assess bacillus Calmette-Guérin maintenance treatment schedule for non-muscle invasive bladder cancer at 2 years, using one-third of the full dose and fewer instillations every 3 months or 6 months.
  
  
  METHODS
  This was a prospective, randomized, multicenter study. All patients had an intermediate- or high-risk non-muscle invasive bladder cancer. They received three weekly instillations of one-third dose bacillus Calmette-Guérin every 6 months (group I) and two weekly instillations every 3 months (group II) during 3 years. In the two schedules we assessed efficacy, tolerance, leukocyturia and prostate-specific antigen.
  
  
  RESULTS
  No significant difference was observed between the two groups for recurrence at 6, 12 or 18 months. At 2 years, tumor recurrence was observed in 10.9% and muscle invasion in 2.9% of cases. Bacillus Calmette-Guérin tolerance was comparable - the adverse events score was 0.8 in group I and 1 in group II (P = 0.242). No statistical correlation was observed between the adverse events score over 2 years, either for leukocyturia (P = 0.8891) or prostate-specific antigen level (P = 0.7155). Leukocyturia level was not significantly associated with tumor recurrence or progression.
  
  
  CONCLUSIONS
  One-third dose maintenance bacillus Calmette-Guérin is effective with no impact on tumor recurrence or muscle invasion. Furthermore, there seems to be no difference in tumor response or side-effects between patients receiving two or three maintenance instillations every 3 months or 6 months. In clinical practice, the use of leukocyturia or total prostate-specific antigen levels do not appear to be useful in predicting bacillus Calmette-Guérin toxicity.
authors.affiliation: Urology Department, Charles Nicolle University Hospital, Rouen, France; Clinical Investigation Center, Inserm 6204, Onco-Urology Group, Rouen, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Pfister
authors.forename: Walid
authors.initials: W
authors.lastname: Kerkeni
authors.forename: Jerome
authors.initials: J
authors.lastname: Rigaud
authors.forename: Sophie
authors.initials: S
authors.lastname: Le Gal
authors.forename: Fabien
authors.initials: F
authors.lastname: Saint
authors.forename: Marc
authors.initials: M
authors.lastname: Colombel
authors.forename: Laurent
authors.initials: L
authors.lastname: Guy
authors.forename: Herve
authors.initials: H
authors.lastname: Wallerand
authors.forename: Jacques
authors.initials: J
authors.lastname: Irani
authors.forename: Michel
authors.initials: M
authors.lastname: Soulie
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007108:Immune Tolerance; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D017430:Prostate-Specific Antigen; D011776:Pyuria; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D001500:BCG Vaccine; D017430:Prostate-Specific Antigen
keywords: bacillus Calmette-Guérin; bladder cancer; maintenance; recurrence; side-effects