The prognostic value of routine second transurethral resection in patients with newly diagnosed stage pT1 non-muscle-invasive bladder cancer: results from randomized 10-year extension trial.

PURPOSE: To evaluate the impact of routine second TUR on the long-term outcome of patients with newly diagnosed stage pT1 non-muscle-invasive bladder cancer (NMIBC)
MATERIAL AND METHODS: A total of 210 patients (mean age 62.1 years, 89.5% were males) with stage pT1 NMIBC who underwent first TUR were prospectively randomized into two groups including second TUR (n = 105) and no second TUR (n = 105) groups. Data on recurrence, disease progression, 7-year and 10-year recurrence-free survival (RFS), progression-free survival (PFS) and overall survival (OS) were recorded.
RESULTS: The median follow-up time was 119 months (IQR 65-168). Per-protocol (PP) analysis revealed that compared to patients without second TUR, patients with second TUR had significantly higher 5-year, 7-year and 10-year rates for RFS (59.4%, 57.9% and 54.8% vs. 36.3%, 31.7% and 26.8%, respectively, p < 0.001) and PFS (93.3%, 91.9% and 90.4% vs. 74.0%, 71.4% and 68.5%, respectively, p < 0.001). According to PP and intention-to-treat (ITT) analyses, the 10-year OS rate was significantly higher in patients with second TUR (59.1 vs. 40.8%, p = 0.004). Multivariate analysis revealed that undergoing second TUR (OR 1.661, 95% CI 1.156-2.385, p = 0.006) was an independent determinant of prolonged OS.
CONCLUSIONS: In conclusion, these findings indicate the prognostic value of second TUR in stage pT1 NMIBC patients, not only for RFS and PFS advantages but also for the long-term OS advantage. Therefore, second TUR should be routinely performed in all stage pT1 NMIBC patients with life expectancy of at least 10 years, given the positive contribution to all oncological outcomes.

RCT Entities:   Population Interventions Outcomes