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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

European Urology



The impact of prognostic factors in T1G3 non–muscle-invasive bladder cancer (BCa) patients is critical for proper treatment decision making.


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.

Design, setting, and participants

Individual patient data were collected for 2451 T1G3 patients from 23 centers who received BCG between 1990 and 2011.

Outcome measurements and statistical analysis

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).

Results and limitations

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.


T1G3 patients ≥70 yr with tumors ≥3 cm and concomitant CIS should be treated more aggressively because of the high risk of progression.

Patient summary

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.

Take Home Message

In T1G3 patients initially treated with at least an induction course of bacillus Calmette-Guérin, the subgroup aged >70 yr with tumor size >3 cm and concomitant carcinoma in situ has an unfavorable outcome and should be considered for early, more aggressive treatment.

Keywords: Bacillus Calmette-Guérin, BCG, Non–muscle-invasive bladder cancer, Prognostic factors, T1G3.


a Department of Surgical Sciences, Molinette Hospital, University of Studies of Turin, Turin, Italy

b EORTC Headquarters, Brussels, Belgium

c Oncologic and Reconstructive Urology, Department of Urology, University Hospitals Leuven, Leuven, Belgium

d Department of Urology, Paolo Giaccone General Hospital, Palermo, Italy

e Department of Surgical Science, John Radcliffe Hospital, University of Oxford, Oxford, UK

f Policlinico Tor Vergata-University of Rome, Rome, Italy

g Department of Urology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands

h Department of Urology and Department for Health Evidence, Radboud University Medical Centre, Nijmegen, The Netherlands

i Dipartimento di Urologia, Università Vita-Salute, Ospedale S. Raffaele, Milan, Italy

j Department of Urology, Motol Hospital, 2nd Faculty of Medicine, Charles, University of Prague, Prague, Czech Republic

k Department of Surgical Sciences, Uppsala University, Uppsala, Sweden

l Department of Urology, Centre Hospitalier Universitaire La Milétrie, University of Poitiers, Poitiers, France

m Department of Urology, Spanish National Cancer Research Centre-Madrid, Madrid, Spain

n Institute of Urology, Rabin Medical Center, Petach Tikva and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

o Department of Urology, Santa Chiara Hospital, Trento, Italy

p 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

q Facharzt fur Urologie, Abteilung fur Urologie, Chirurgische Universitatsklinik, Freiburg, Germany

r Department of Urology, Sismanoglio Hospital, University of Athens, Athens, Greece

s Urology Unit, S. Maria Annunziata Hospital, University of Florence, Florence, Italy

t Department of Urology, University Hospital of Wuerzburg, Wuertzburg, Germany

u Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden

v Department of Urology, General Teaching Hospital and 1st Faculty of Medicine, Charles University in Praha, Praha, Czech Republic

w Cochin Hospital, Paris Descartes University, Paris, France

x Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA

y Department of Urology, Mayo Clinic, Rochester, MN, USA

z Department of Urology, Comprehensive Cancer Center Medical University Vienna, Vienna, Austria

aa Department of Urology, Fundacio Puigvert, University of Barcelona, Barcelona, Spain

lowast Corresponding author. Urology Clinic, Department of Surgical Sciences, San Giovanni Battista Hospital, C.so Bramante 88/90, 10126 Turin, Italy. Tel.: +390116335581; Fax: +390116706670.