Re: Randomized Phase III Trial on Gemcitabine Versus Mytomicin in Recurrent Superficial Bladder Cancer: Evaluation of Efficacy And Tolerance

摘要

Expert's summary: This study was a prospective randomized trial of mitomycin C (MMC) and gemcitabine (GEM) in 120 patients with recurrent noninvasive bladder cancer. Most of the patients in each arm had failed prior bacillus Calmette-Guerin (BCG) therapy. Patients received initial induction and then maintenance therapy with 10 monthly treatments during the first year. With a median follow-up of 36 mo, 72% and 61% of GEM and MMC patients were free of recurrence, respectively. The GEM arm had a statistically significant improvement in disease-free survival overall and among grade 3 patients. However, among patients with grade 3 disease and 30-mo follow-up, >50% of patients in each arm recurred but fewer in the GEM arm. Furthermore, 10 patients in the MMC arm and 6 in the GEM arm progressed in stage, but this was not a statistically significant difference. The total incidence of adverse events was greater in the MMC arm (38.8% vs 72.2%; p = 0.021).