Prognostic Factors and Risk Groups in T1G3 Non–Muscle-invasive Bladder Cancer Patients Initially Treated with Bacillus Calmette-Gue´ rin: Results of a retrospective Multicenter Study of 2451 Patients

Background: The impact of prognostic factors in T1G3 non–muscle-invasive bladdercancer (BCa) patients is critical for proper treatment decision making.Objective: To assess prognostic factors in patients who received bacillus Calmette-Gue´ rin (BCG) as initial intravesical treatment of T1G3 tumors and to identify a subgroupof high-risk patients who should be considered for more aggressive treatment. Design, setting, and participants: Individual patient data were collected for 2451 T1G3patients 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. Inmultivariable analyses, the most important prognostic factors for progression wereage, tumor size, and concomitant carcinoma in situ (CIS); the most important prognosticfactors for BCa-specific survival and OS were age and tumor size. Patients were dividedinto four risk groups for progression according to the number of adverse factors amongage 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 betreated more aggressively because of the high risk of progression.Patient summary: Although the majority of T1G3 patients can be safely treated withintravesical bacillus Calmette-Gue´ rin, 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 andthus require aggressive treatment.