PROGNOSTIC FACTORS AND RISK GROUPS IN T1G3 PATIENTS INITIALLY TREATED WITH BCG: RESULTS OF A MULTICENTER RETROSPECTIVE SERIES IN 2530 PATIENTS

INTRODUCTION AND OBJECTIVES: The impact of prognosticfactors in T1G3 patients (pts) is critical for proper treatment decisionmaking, however most available data are from small series of pts. Theaim of the current study is to assess prognostic factors in a large groupof pts who received BCG as initial treatment of T1G3 tumours andidentify a subgroup of high risk pts who should be considered for earlycystectomy.METHODS: Individual pt data were collected for 2530 pts from23 centers who received induction or maintenance BCG between 1990and 2008. Using Cox regression analysis, the prognostic importance ofthe following variables were assessed for time to recurrence, progressionto muscle invasive disease and overall survival: age ( 70 vs 70yrs), gender, primary T1G3 vs recurrent T1G3 after previous non T1G3tumour, tumour size ( 3 vs 3 cm), multiplicity (single vs multiple),concomitant CIS (no/yes), and maintenance BCG (no/yes).RESULTS: Median age was 68 yrs, 82% were male, 89% wereprimary T1G3, 58% had multifocal disease, 67% had tumours less than3 cm, 25% had concomitant CIS, 42% had a restaging TUR, 37%received some sort of maintenance BCG. With a follow up out to 15years, 1300 pts (51%) recurred, 480 (19%) progressed, 523 underwentcystectomy (21%) and 623 (25%) died, 230 (9%) due to bladdercancer. In multivariate analyses, the most important prognostic factors(p 0.01) for recurrence were: tumour size and multiplicity; for progression:age, size and concomitant CIS; for overall survival: age andsize. Maintenance BCG had a positive impact on recurrence (p 0.001), progression (p 0.007) and survival (p .002). Patients weredivided into 4 risk groups according to the number of bad factors forprogression among age 70, size 3 cm and presence of CIS.Progression free rates at 10 yrs were 82%, 73%, 67% and 42% forpatients with 0, 1, 2 and 3 bad factors while the corresponding overallsurvival rates were 78%, 53%, 46% and 16%, respectively.CONCLUSIONS: T1G3 patients treated with BCG have a heterogeneousprognosis, with overall survival at 10 yrs ranging from 78%to 16%. Although maintenance BCG improves outcome as comparedto induction alone, fit pts over 70 yrs of age with tumours greater than3 cm and concomitant CIS should be considered for an early cystectomy.