title: Prognostic factors and risk groups in T1G3 non-muscle-invasive bladder cancer patients initially treated with Bacillus Calmette-Guérin: results of a retrospective multicenter study of 2451 patients.
abstract: BACKGROUND
  The impact of prognostic factors in T1G3 non-muscle-invasive bladder cancer (BCa) patients is critical for proper treatment decision making.
  
  
  OBJECTIVE
  To assess prognostic factors in patients who received bacillus Calmette-Guérin (BCG) as initial intravesical treatment of T1G3 tumors and to identify a subgroup of high-risk patients who should be considered for more aggressive treatment.
  
  
  METHODS
  Individual patient data were collected for 2451 T1G3 patients from 23 centers who received BCG between 1990 and 2011.
  
  
  METHODS
  Using Cox multivariable regression, the prognostic importance of several clinical variables was assessed for time to recurrence, progression, BCa-specific survival, and overall survival (OS).
  
  
  CONCLUSIONS
  With a median follow-up of 5.2 yr, 465 patients (19%) progressed, 509 (21%) underwent cystectomy, and 221 (9%) died because of BCa. In multivariable analyses, the most important prognostic factors for progression were age, tumor size, and concomitant carcinoma in situ (CIS); the most important prognostic factors for BCa-specific survival and OS were age and tumor size. Patients were divided into four risk groups for progression according to the number of adverse factors among age ≥ 70 yr, size ≥ 3 cm, and presence of CIS. Progression rates at 10 yr ranged from 17% to 52%. BCa-specific death rates at 10 yr were 32% in patients ≥ 70 yr with tumor size ≥ 3 cm and 13% otherwise.
  
  
  CONCLUSIONS
  T1G3 patients ≥ 70 yr with tumors ≥ 3 cm and concomitant CIS should be treated more aggressively because of the high risk of progression.
  
  
  RESULTS
  Although the majority of T1G3 patients can be safely treated with intravesical bacillus Calmette-Guérin, there is a subgroup of T1G3 patients with age ≥ 70 yr, tumor size ≥ 3 cm, and concomitant CIS who have a high risk of progression and thus require aggressive treatment.
authors.affiliation: Department of Surgical Sciences, Molinette Hospital, University of Studies of Turin, Turin, Italy. Electronic address: paolo.gontero@unito.it.
authors.forename: Paolo
authors.initials: P
authors.lastname: Gontero
authors.affiliation: EORTC Headquarters, Brussels, Belgium.
authors.forename: Richard
authors.initials: R
authors.lastname: Sylvester
authors.affiliation: Department of Surgical Sciences, Molinette Hospital, University of Studies of Turin, Turin, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Pisano
authors.affiliation: Oncologic and Reconstructive Urology, Department of Urology, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Steven
authors.initials: S
authors.lastname: Joniau
authors.affiliation: Oncologic and Reconstructive Urology, Department of Urology, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Kathy
authors.initials: K
authors.lastname: Vander Eeckt
authors.affiliation: Department of Urology, Paolo Giaccone General Hospital, Palermo, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Serretta
authors.affiliation: Department of Surgical Science, John Radcliffe Hospital, University of Oxford, Oxford, UK.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Larré
authors.affiliation: Policlinico Tor Vergata-University of Rome, Rome, Italy.
authors.forename: Savino
authors.initials: S
authors.lastname: Di Stasi
authors.affiliation: Department of Urology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
authors.forename: Bas
authors.initials: B
authors.lastname: Van Rhijn
authors.affiliation: Department of Urology and Department for Health Evidence, Radboud University Medical Centre, Nijmegen, The Netherlands.
authors.forename: Alfred J
authors.initials: AJ
authors.lastname: Witjes
authors.affiliation: Department of Urology and Department for Health Evidence, Radboud University Medical Centre, Nijmegen, The Netherlands.
authors.forename: Anne J
authors.initials: AJ
authors.lastname: Grotenhuis
authors.affiliation: Department of Urology and Department for Health Evidence, Radboud University Medical Centre, Nijmegen, The Netherlands.
authors.forename: Lambertus A
authors.initials: LA
authors.lastname: Kiemeney
authors.affiliation: Dipartimento di Urologia, Università Vita-Salute, Ospedale S. Raffaele, Milan, Italy.
authors.forename: Renzo
authors.initials: R
authors.lastname: Colombo
authors.affiliation: Dipartimento di Urologia, Università Vita-Salute, Ospedale S. Raffaele, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Briganti
authors.affiliation: Department of Urology, Motol Hospital, 2nd Faculty of Medicine, Charles, University of Prague, Prague, Czech Republic.
authors.forename: Marek
authors.initials: M
authors.lastname: Babjuk
authors.affiliation: Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
authors.forename: Per-Uno
authors.initials: PU
authors.lastname: Malmström
authors.affiliation: Department of Surgical Sciences, Molinette Hospital, University of Studies of Turin, Turin, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Oderda
authors.affiliation: Department of Urology, Centre Hospitalier Universitaire La Milétrie, University of Poitiers, Poitiers, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Irani
authors.affiliation: Department of Urology, Spanish National Cancer Research Centre-Madrid, Madrid, Spain.
authors.forename: Nuria
authors.initials: N
authors.lastname: Malats
authors.affiliation: Institute of Urology, Rabin Medical Center, Petach Tikva and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Jack
authors.initials: J
authors.lastname: Baniel
authors.affiliation: Institute of Urology, Rabin Medical Center, Petach Tikva and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Roy
authors.initials: R
authors.lastname: Mano
authors.affiliation: Department of Urology, Santa Chiara Hospital, Trento, Italy.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Cai
authors.affiliation: Department of Urology, Weill Medical College of Cornell University, New York, NY, USA, and Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors.forename: Eugene K
authors.initials: EK
authors.lastname: Cha
authors.affiliation: Facharzt fur Urologie, Abteilung fur Urologie, Chirurgische Universitatsklinik, Freiburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Ardelt
authors.affiliation: Department of Urology, Sismanoglio Hospital, University of Athens, Athens, Greece.
authors.forename: John
authors.initials: J
authors.lastname: Varkarakis
authors.affiliation: Urology Unit, S. Maria Annunziata Hospital, University of Florence, Florence, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Bartoletti
authors.affiliation: Department of Urology, University Hospital of Wuerzburg, Wuertzburg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Spahn
authors.affiliation: Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.
authors.forename: Robert
authors.initials: R
authors.lastname: Johansson
authors.affiliation: Department of Surgical Sciences, Molinette Hospital, University of Studies of Turin, Turin, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Frea
authors.affiliation: Department of Urology, General Teaching Hospital and 1st Faculty of Medicine, Charles University in Praha, Praha, Czech Republic.
authors.forename: Viktor
authors.initials: V
authors.lastname: Soukup
authors.affiliation: Cochin Hospital, Paris Descartes University, Paris, France.
authors.forename: Evanguelos
authors.initials: E
authors.lastname: Xylinas
authors.affiliation: Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors.forename: Guido
authors.initials: G
authors.lastname: Dalbagni
authors.affiliation: Department of Urology, Mayo Clinic, Rochester, MN, USA.
authors.forename: R Jeffrey
authors.initials: RJ
authors.lastname: Karnes
authors.affiliation: Department of Urology, Comprehensive Cancer Center Medical University Vienna, Vienna, Austria.
authors.forename: Shahrokh F
authors.initials: SF
authors.lastname: Shariat
authors.affiliation: Department of Urology, Fundacio Puigvert, University of Barcelona, Barcelona, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Palou
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000367:Age Factors; D000368:Aged; D001500:BCG Vaccine / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000150:complications*; D015653:Cystectomy; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology* / Q000601:surgery; D011379:Prognosis; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D015996:Survival Rate; D047368:Tumor Burden; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine
keywords: BCG; Bacillus Calmette-Guérin; Non–muscle-invasive bladder cancer; Prognostic factors; T1G3