Re: Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-grade Non-muscle-invasive Bladder Cancer on Tumor Recurrence
Abstrakt
The authors present results from a randomized double-blind multicenter trial evaluating the role of single immediate instillation (SI) of gemcitabine after transurethral resection (TURB) of presumed low-grade (LG) non-muscle-invasive bladder cancer (NMIBC). Overall, 406 patients were randomized to SI of 2 g of gemcitabine in 100 ml of saline or to 100 ml of saline alone within 3 h after TURB, and 383 completed the trial.
After median follow-up of 4 yr, 35% of patients in the gemcitabine arm and 47% in the saline group experienced recurrence in an intention-to-treat (ITT) analysis (hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.48-0.90; p < 0.001). In the prespecified target population with pathologically confirmed LG NMIBC, 34 of 102 patients receiving gemcitabine (34%) and 59 of 113 patients receiving saline (54%) had recurrences (HR 0.53, 95% CI 0.35-0.81; p = 0.001).