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. 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. CONCLUSIONS: 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.

Cochin Hospital Paris Descartes University Paris France

Department of Radiation Sciences Oncology Umeå University Umeå Sweden

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

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

Department of Surgical Sciences Uppsala University Uppsala Sweden

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

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

Department of Urology Comprehensive Cancer Center Medical University Vienna Vienna Austria

Department of Urology Fundacio Puigvert University of Barcelona Barcelona Spain

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

Department of Urology Mayo Clinic Rochester MN USA

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

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

Department of Urology Paolo Giaccone General Hospital Palermo Italy

Department of Urology Santa Chiara Hospital Trento Italy

Department of Urology Sismanoglio Hospital University of Athens Athens Greece

Department of Urology Spanish National Cancer Research Centre Madrid Madrid Spain

Department of Urology University Hospital of Wuerzburg Wuertzburg Germany

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

Dipartimento di Urologia Università Vita Salute Ospedale S Raffaele Milan Italy

EORTC Headquarters Brussels Belgium

Facharzt fur Urologie Abteilung fur Urologie Chirurgische Universitatsklinik Freiburg Germany

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

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

Policlinico Tor Vergata University of Rome Rome Italy

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

Urology Unit S Maria Annunziata Hospital University of Florence Florence Italy

Comment In

Eur Urol. 2015 Jan;67(1):83-84. doi: 10.1016/j.eururo.2014.07.019. PubMed

Comment In

Eur Urol. 2015 Jan;67(1):e7. doi: 10.1016/j.eururo.2014.08.062. PubMed

Comment In

Eur Urol. 2014 Nov;66(5):968-9. doi: 10.1016/j.eururo.2014.08.032. PubMed

Comment In

J Urol. 2016 May;195(5):1382. doi: 10.1016/j.juro.2016.02.008. PubMed

References provided by Crossref.org

Comparative Outcomes of Primary Versus Recurrent High-risk Non-muscle-invasive and Primary Versus Secondary Muscle-invasive Bladder Cancer After Radical Cystectomy: Results from a Retrospective Multicenter Study

Impact of preoperative plasma levels of interleukin 6 and interleukin 6 soluble receptor on disease outcomes after radical cystectomy for bladder cancer

Association of patients' sex with treatment outcomes after intravesical bacillus Calmette-Guérin immunotherapy for T1G3/HG bladder cancer

Prognostic value of albumin to globulin ratio in non-muscle-invasive bladder cancer

Association of De Ritis ratio with oncological outcomes in patients with non-muscle invasive bladder cancer (NMIBC)

Discovery of Molecular DNA Methylation-Based Biomarkers through Genome-Wide Analysis of Response Patterns to BCG for Bladder Cancer

Predictors of oncological outcomes in T1G3 patients treated with BCG who undergo radical cystectomy

Recurrence, progression and cancer-specific mortality according to stage at re-TUR in T1G3 bladder cancer patients treated with BCG: not as bad as previously thought

The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non-muscle-invasive bladder cancer

The impact of re-transurethral resection on clinical outcomes in a large multicentre cohort of patients with T1 high-grade/Grade 3 bladder cancer treated with bacille Calmette-Guérin