title: [Complications of endovesical treatment with BCG in a series of 200 patients].
abstract: OBJECTIVE
  To describe and quantify the side effects of intravesical BCG therapy (Connaught strain) in different therapeutic protocols.
  
  
  METHODS
  200 patients were studied; 126 treated according to the standard protocol of our hospital (modality 1 and modality 2: twelve and nine 81 mg instillations, respectively) and 74 patients in the CUETO protocols (90008, 93009, 95011, 95012). Classification of BCG toxicity was based on the criteria utilized by Lamm which divides it into side effects and complications. We have distinguished side effects further as local irritative symptoms (LIS) and cystitis.
  
  
  RESULTS
  The most common side effects were LIS (80%) and cystitis (21.5%). The incidence of cystitis (44.4%) and general malaise (44.4%) was higher for modality 1 than for modality 2 (24.1% and 20.3%, respectively). The CUETO 93009 protocol (mitomycin + BCG) showed the highest incidence of side effects (LIS 100%, cystitis 57.1% and fever < 39 degrees C 71.4%). The most frequent complication was fever > 39 degrees C (4%), followed by hepatitis (3%). The rate of bladder retraction was notably high (1.5%), requiring cystectomy with neobladder substitution in two cases. The overall complication rate for modality 1 (16.6%) was reduced when modality 2 was utilized (8.3%). In the CUETO 90008 protocol, dose reduction did not reduce the complication rate (81 mg: 7.1%; 21 mg: 19.2%). BCG therapy was discontinued in 14%.
  
  
  CONCLUSIONS
  Toxicity due to intravesical BCG therapy did not decrease when the dose was reduced, but diminished in number and intensity when the number of consecutive instillations was reduced.
authors.affiliation: Servicio de Urología, Hospital Nuestra Señora del Pino, Universidad Las Palmas de Gran Canaria, España. luisre@idecnet.com
authors.forename: L E
authors.initials: LE
authors.lastname: Resel Folkersma
authors.forename: J A
authors.initials: JA
authors.lastname: Belón Lopéz Tomasetti
authors.forename: S
authors.initials: S
authors.lastname: Isorna Martínez de la Riva
authors.forename: J A
authors.initials: JA
authors.lastname: Caminero Luna
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects*; D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine