title: The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non-muscle-invasive bladder cancer.
abstract: Potential differences in efficacy of different bacillus Calmette-Guérin (BCG) strains are of importance for daily practice, especially in the era of BCG shortage.
  
  
  
  To retrospectively compare the outcome with BCG Connaught and BCG TICE in a large study cohort of pT1 high-grade non-muscle-invasive bladder cancer patients.
  
  
  
  Individual patient data were collected for 2,451 patients with primary T1G3 tumors from 23 centers who were treated with BCG for the first time between 1990 and 2011.
  
  
  
  Using Cox multivariable regression and adjusting for the most important prognostic factors in this nonrandomized comparison, BCG Connaught and TICE were compared for time to recurrence, progression, and the duration of cancer specific survival and overall survival.
  
  
  
  Information on the BCG strain was available for 2,099 patients: 957 on Connaught and 1,142 on TICE. Overall, 765 (36%) patients received some form of maintenance BCG, 560 (59%) on Connaught and 205 (18%) on TICE. Without maintenance, Connaught was more effective than TICE only for the time to first recurrence (hazard ratio [HR] = 1.48; 95% CI: 1.20-1.82; P<0.001). With maintenance, TICE was more effective than Connaught for the time to first recurrence (HR = 0.66; 95% CI: 0.47-0.93; P = 0.019) with a trend for cancer specific survival (HR = 0.36; 95% CI: 0.14-0.92; P = 0.033). For time to progression and overall survival, Connaught and TICE had a similar efficacy. Compared to no maintenance therapy, maintenance BCG significantly reduced the risk of recurrence, progression and death, both overall, and disease specific, for TICE, but not for Connaught.
  
  
  
  We found that BCG Connaught results in a lower recurrence rate as compared with BCG TICE when no maintenance is used. However, the opposite is true when maintenance is given.
  
  
  
  As there is currently a BCG shortage, information on the efficacy of different BCG strains is important. In this nonrandomized retrospective comparison in over 2,000 patients, we found that BCG Connaught reduces the recurrence rate compared to BCG TICE when no maintenance is used, but the opposite is true when maintenance is given.
authors.affiliation: Department of Urology, RadboudUMC, Nijmegen, The Netherlands. Electronic address: fred.witjes@radboudumc.nl.
authors.forename: J Alfred
authors.initials: JA
authors.lastname: Witjes
authors.affiliation: Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY.
authors.forename: Guido
authors.initials: G
authors.lastname: Dalbagni
authors.affiliation: Department of Urology, Mayo Clinic, Rochester, MN.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Karnes
authors.affiliation: Department of Urology, Comprehensive Cancer Center Medical University Vienna, Vienna, Austria.
authors.forename: Shahrokh
authors.initials: S
authors.lastname: Shariat
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: Department of Urology, Fundacio Puigvert, University of Barcelona, Barcelona, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Palou
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: Dipartimento di Urologia, Universita` Vita-Salute, Ospedale S. Raffaele, Milan, Italy.
authors.forename: Renzo
authors.initials: R
authors.lastname: Colombo
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 Urology, Spanish National Cancer Research Centre-Madrid, Madrid, Spain.
authors.forename: Nuria
authors.initials: N
authors.lastname: Malats
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: 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: 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; Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY.
authors.forename: Eugene
authors.initials: E
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 Surgical Sciences, Molinette Hospital, University of Studies of Turin, Turin, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Pisano
authors.affiliation: Department of Surgical Sciences, Molinette Hospital, University of Studies of Turin, Turin, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Gontero
authors.affiliation: Formerly Department of Biostatistics, EORTC Headquarters, Brussels, Belgium.
authors.forename: Richard
authors.initials: R
authors.lastname: Sylvester
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000283:Administration, Intravesical; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000473:pathology / Q000628:therapy*; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016233:Immunotherapy, Active; D053208:Kaplan-Meier Estimate; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D012008:Recurrence; D012189:Retrospective Studies; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000473:pathology / Q000628:therapy*
chemical_list: D000276:Adjuvants, Immunologic; C087507:BCG Connaught; D001500:BCG Vaccine
keywords: BCG Connaught; BCG Tice; BCG vaccine; Immunotherapy; Intravesical drug administration; T1G3; bladder cancer; high grade; progression; recurrence