title: Increasing age is not associated with toxicity leading to discontinuation of treatment in patients with urothelial non-muscle-invasive bladder cancer randomised to receive 3 years of maintenance bacille Calmette-Guérin: results from European Organisation for Research and Treatment of Cancer Genito-Urinary Group study 30911.
abstract: OBJECTIVE
  To determine the relationship of age to side-effects leading to discontinuation of treatment in patients with stage Ta-T1 non-muscle-invasive bladder cancer (NMIBC) treated with maintenance bacille Calmette-Guérin (BCG).
  
  
  METHODS
  We evaluated toxicity for 487 eligible patients with intermediate- or high-risk Ta-T1 (without carcinoma in situ) NMIBC randomised to receive 3 years of maintenance BCG therapy (247 BCG alone and 240 BCG + isoniazid) in European Organisation for Research and Treatment of Cancer Genito-Urinary Group trial 30911. The percentage of patients who stopped for toxicity and the number of treatment cycles that they received were compared in four age groups, ≤60, 61-70, 71-75 and >75 years, using the Mantel-Haenszel chi-square test for trend.
  
  
  RESULTS
  The percentage of patients stopping BCG for toxicity was 17.9% in patients aged ≤60 years, 21.9% in patients aged 61-70 years, 22.9% in patients aged 71-75 years, and 16.4% in patients aged >75 years (P = 0.90). For both systemic and local side-effects, there was likewise no significant difference.
  
  
  CONCLUSIONS
  In patients with intermediate- and high-risk Ta-T1 NMIBC treated with BCG, no differences in toxicity as a reason for stopping treatment were detected based on patient age.
authors.affiliation: Department of Urology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
authors.forename: Jorg R
authors.initials: JR
authors.lastname: Oddens
authors.affiliation: Department of Biostatistics, European Organization for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Sylvester
authors.affiliation: Department of Urology, AUSL, Modena, Italy.
authors.forename: Maurizio A
authors.initials: MA
authors.lastname: Brausi
authors.affiliation: Department of Urology, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Wim J
authors.initials: WJ
authors.lastname: Kirkels
authors.affiliation: Department of Urology, Maastricht UMC+, Maastricht, The Netherlands.
authors.forename: Cees
authors.initials: C
authors.lastname: van de Beek
authors.affiliation: Department of Urology, OLVG, Amsterdam, The Netherlands.
authors.forename: George
authors.initials: G
authors.lastname: van Andel
authors.affiliation: Department of Urology, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: Theo M
authors.initials: TM
authors.lastname: de Reijke
authors.affiliation: Department of Urology, St James's University Hospital, Leeds, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Prescott
authors.affiliation: Department of Urology, Radboud UMC, Nijmegen, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Alfred Witjes
authors.affiliation: Department of Urology, Gent University Hospital, Ghent, Belgium.
authors.forename: Willem
authors.initials: W
authors.lastname: Oosterlinck
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects*; D000367:Age Factors; D000368:Aged; D001500:BCG Vaccine / Q000009:adverse effects*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D028761:Withholding Treatment / Q000706:statistics & numerical data*
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine
keywords: age; bacille Calmette-Guérin; non-muscle-invasive bladder cancer; side-effects; toxicity