膀胱肿瘤卡介苗灌注ppt课件

Results
• local side effects(safety population):
• frequency (65% of patients; NM 58%; M,71%), • dysuria (63%; NM 57%;M69.5%); • Haematuria (43%;NM, 33.5%; M 52%). • general malaise (7.2%;NM, 5.8%; M 8.5%) • fever (34%;NM, 27%; M, 41%).
Discussion
BCG instillation every 3 mo as maintenance therapy after the 6-wk induction course could provide sufficient immunological stimulus to avoid disease recurrence and tumour progression. For administration of a single instillation every 3mo over 3 yr, patients received 18 BCG instillations compared with 27 for the classic SWOG regimen. The lower number of instillations was associated with low toxicity.
Results
Results

Results
Results
Toxicity : 20 (10%) . Recurrence in 40 (20%). other reasons in 71 (35.5%). (48 received ten or more BCG instillations)
• In this study we did not observe decreases in recurrence and progression rates compared with induction therapy alone. This problem is expecting for further research.
methods
• 1. No maintenance: BCG was instilled once-weekly for 6 wk (a total of 6 instillations). • 2. Maintenance: BCG was instilled once-weekly for 6 wk, followed by maintenance therapy with a single instillation every 3 mo for 3 yr (a total of 18 instillations).
Limitations
• no central pathology review; • no restaging TUR; • some induction patients also received short maintenance therapies; • a relatively high rate of treatment discontinuation in the maintenance arm; • limited statistical power.
膀胱肿瘤卡介苗灌注
Journal
Contents
Introduction. Patients and methods. Results. Discussion. Limitations.
Introduction
• Patients with high-risk NMIBC are usually treated with adjuvant intravesical instillations of BCG after TUR. The aim is to decrease the risk of recurrence and—to a lesser extent—progression to MIBC. • EU guidelines recommend standard induction therapy with onceweekly BCG instillation for 6 wk and at least 1 yr of maintenance therapy with additional instillations of BCG . • BCG maintenance therapy for 3 yr following BCG induction can reduce the progression of urothelial bladder carcinoma versus BCG induction alone, but is associated with high toxicity.
Results
Primary endpoints were disease-free interval (DFI) and time to progression (TTP). Secondary endpoints included survival duration and toxicity. Differences between treatment arms were tested using Student’s t test and x2 and log-rank tests.
Patients
Patients from the outpatient clinics of the participating centres(18) with high-risk NMIBC were randomised between October 1999 and April 2007 in Spain.