title: EORTC Nomograms and Risk Groups for Predicting Recurrence, Progression, and Disease-specific and Overall Survival in Non-Muscle-invasive Stage Ta-T1 Urothelial Bladder Cancer Patients Treated with 1-3 Years of Maintenance Bacillus Calmette-Guérin.
abstract: BACKGROUND
  There are no prognostic factor publications on stage Ta-T1 non-muscle-invasive bladder cancer (NMIBC) treated with 1-3 yr of maintenance bacillus Calmette-Guérin (BCG).
  
  
  OBJECTIVE
  To determine prognostic factors in NMIBC patients treated with 1-3 yr of BCG after transurethral resection of the bladder (TURB), to derive nomograms and risk groups, and to identify high-risk patients who should be considered for early cystectomy.
  
  
  METHODS
  Data for 1812 patients were merged from two European Organization for Research and Treatment of Cancer randomized phase 3 trials in intermediate- and high-risk NMIBC.
  
  
  METHODS
  Patients received 1-3 yr of maintenance BCG after TURB and induction BCG.
  
  
  METHODS
  Prognostic factors for risk of early recurrence and times to late recurrence, progression, and death were identified in a training data set using multivariable models and applied to a validation data set.
  
  
  CONCLUSIONS
  With a median follow-up of 7.4 yr, 762 patients recurred; 173 progressed; and 520 died, 83 due to bladder cancer (BCa). Statistically significant prognostic factors identified by multivariable analyses were prior recurrence rate and number of tumors for recurrence, and tumor stage and grade for progression and death due to BCa. T1G3 patients do poorly, with 1- and 5-yr disease-progression rates of 11.4% and 19.8%, respectively, and 1- and 5-yr disease-specific death rates of 4.8% and 11.3%. Limitations include lack of repeat transurethral resection in high-risk patients and exclusion of patients with carcinoma in situ.
  
  
  CONCLUSIONS
  NMIBC patients treated with 1-3 yr of maintenance BCG have a heterogeneous prognosis. Patients at high risk of recurrence and/or progression do poorly on currently recommended maintenance schedules. Alternative treatments are urgently required.
  
  
  RESULTS
  Non-muscle-invasive bladder cancer patients at high risk of recurrence and/or progression do poorly on currently recommended bacillus Calmette-Guérin maintenance schedules, and alternative treatments are urgently required.
  
  
  BACKGROUND
  Study 30911 was registered with the US National Cancer Institute clinical trials database (protocol ID: EORTC 30911). Study 30962 was registered at ClinicalTrials.gov, number NCT00002990; http://clinicaltrials.gov/ct2/show/record/NCT00002990.
authors.affiliation: EORTC Headquarters, Brussels, Belgium.
authors.forename: Samantha
authors.initials: S
authors.lastname: Cambier
authors.affiliation: EORTC Headquarters, Brussels, Belgium. Electronic address: richard.sylvester@eortc.be.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Sylvester
authors.affiliation: EORTC Headquarters, Brussels, Belgium.
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
authors.affiliation: Department of Surgical Sciences, Molinette Hospital, Torino, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Gontero
authors.affiliation: Department of Urology, AUSL, Modena, Italy.
authors.forename: Maurizio A
authors.initials: MA
authors.lastname: Brausi
authors.affiliation: Department of Urology, OLVG, Amsterdam, The Netherlands.
authors.forename: George
authors.initials: G
authors.lastname: van Andel
authors.affiliation: Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Wim J
authors.initials: WJ
authors.lastname: Kirkels
authors.affiliation: Department of Urology, Hospital Do Desterro, Lisbon, Portugal.
authors.forename: Fernando Calais Da
authors.initials: FC
authors.lastname: Silva
authors.affiliation: Department of Urology, Ghent University Hospital, Ghent, Belgium.
authors.forename: Willem
authors.initials: W
authors.lastname: Oosterlinck
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, Dokuz Eylul University School of Medicine, Izmir, Turkey.
authors.forename: Ziya
authors.initials: Z
authors.lastname: Kirkali
authors.affiliation: Department of Urology, Freeman Hospital, Newcastle Upon Tyne, UK.
authors.forename: Philip H
authors.initials: PH
authors.lastname: Powell
authors.affiliation: Department of Urology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Theo M
authors.initials: TM
authors.lastname: de Reijke
authors.affiliation: Department of Urology, Marmara University School of Medicine, Istanbul, Turkey.
authors.forename: Levent
authors.initials: L
authors.lastname: Turkeri
authors.affiliation: EORTC Headquarters, Brussels, Belgium.
authors.forename: Sandra
authors.initials: S
authors.lastname: Collette
authors.affiliation: Department of Urology, Jeroen Bosch Ziekenhuis, s'-Hertogenbosch, The Netherlands.
authors.forename: Jorg
authors.initials: J
authors.lastname: Oddens
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D009367:Neoplasm Staging; D049451:Nomograms; D011379:Prognosis; D018570:Risk Assessment / Q000379:methods; D015996:Survival Rate; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine
keywords: Bacillus Calmette-Guérin; Non–muscle-invasive bladder cancer; Prognostic factors; Progression; Recurrence; Survival