title: [Tolerance and efficiency of intravesical instillation of Calmette-Guérin in the prophylactic treatment of superficial bladder tumors, using a maintenance treatment].
abstract: Maintenance treatment with complementary BCG instillations in the prevention of superficial bladder tumour could improve the results of this immunotherapy. This maintenance treatment is limited by accentuation of the adverse effects related to BCG.
  
  
  OBJECTIVE
  To evaluate the impact of maintenance treatment on tumour recurrence and progression, and to evaluate the influence of adverse effects on maintenance treatment and the recurrence rate.
  
  
  METHODS
  72 patients were treated with six weekly instillations of 81 mg of BCG (Immucyst) followed by three complementary instillations 3, 6, 12, 18, 24, 30 and 36 months later. Adverse effects (AE) were classified into four classes, according to their type, severity and duration, and were recorded prospectively for 518 instillations. An adverse effect score was determined for each patient.
  
  
  RESULTS
  84.9% of patients did not present any recurrence, 12.5% developed recurrence and 2.6% progressed. The instillation regimen was completed by 19% of patients, the dose had to be decreased for 57% of patients and treatment had to be discontinued for 39% of patients. An initial adverse effect score (AESi) greater than 1.5 was associated with an increased risk of discontinuation of treatment or reduction of the dosage during maintenance treatment (p = 0.01).
  
  
  CONCLUSIONS
  Maintenance treatment was associated with a very low recurrence and progression rate. We have established and validated an adverse effect severity scale and the consequences of these adverse effects on maintenance treatment. This scale could be used to prospectively define the most appropriate maintenance instillation regimen, by preventively decreasing the doses or deferring instillation.
authors.affiliation: Service d'Urologie, Hôpital Henri Mondor, 51, avenue du Maréchal de Lattre de Tassigny, 94010 Créteil. saintf@wanadoo.fr
authors.forename: F
authors.initials: F
authors.lastname: Saint
authors.forename: J
authors.initials: J
authors.lastname: Irani
authors.forename: L
authors.initials: L
authors.lastname: Salomon
authors.forename: H
authors.initials: H
authors.lastname: Debois
authors.forename: C C
authors.initials: CC
authors.lastname: Abbou
authors.forename: D
authors.initials: D
authors.lastname: Chopin
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*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011795:Surveys and Questionnaires; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000517:prevention & control*
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine
vernacular_title: Etude de la tolérance et de l'efficacité des instillations endovésicales de Bacille Calmette-Guérin dans le traitement prophylactique des tumeurs superficielles de vessie, en utilisant un traitement d'entretien.