Develop And Explore A Novel Device With Gemcitabine For Hyperthermic Intravesical Chemotherapy

Purpose: To evaluate the safety and effect of a novel device combined with gemcitabine(GEM)as a new therapy for hyperthermic intravesical chemotherapy(HIVEC).Materials and methods: A pilot clinical trial was performed and patients with high-risk non-muscle invasive bladder cancer(NMIBC)were enrolled and received HIVEC with novel device(BR-PRG).HIVEC were consisted by eight weekly instillations of intravesical GEM(3g in NS 150 m L)at a temperature of 45 ℃ for60 min.The safety assessment of adverse events was the primary objective.Meanwhile,recurrence of disease and the thermal stability of GEM were also analyzed.Results: A total of 116 treatments of HIVEC had been delivered.Fifteen patients were included in the effectiveness analysis and eighteen patients were analyzed in the safety.Median follow-up were 12 months,five patients experienced a disease recurrence.The 1-year cumulative incidence of recurrence was 23.8% for EORTC intermediate risk group(score 5-9)and 36.5% for high risk group(score 10-17).Ten patients experienced at least one adverse event(AE)during the instillation course.The most common AE was acute urinary tract infection(6/18,33.3%),followed by urinary tract pain(5/18,27.8%),haematuria(4/18,22.3%).Two AEs of acute cystitis ranked grade 3,experienced delayed instillations for one week and were fully recovered.Other AEs were all minor(grade 2or less)and no systemic toxicity was observed.The contents of GEM in solution were stable at 25℃,37℃,43℃,45℃,47℃ and 50℃for 2 hours.Conclusion: GEM has good thermal stability which can be an ideal selection used in HIVEC.The novel device of BR-PRG had some unique superiorities in HIVEC,combined with GEM was assessed to be safe and effective.The long-term safety and oncological potential of BR-PRG with GEM should be further evaluated.