1、Maintenance Therapy with 3-monthly Bacillus Calmette-Guerin for 3 Years is Not Superior to Standard Induction Therapy in High-risk Nonmuscle-invasive Urothelial Bladder Carcinoma,Ma junhaiLanzhou University Second Hospital,Journal,Contents,Introduction.Patients and methods.Results.Discussion.Limitat
2、ions.,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 andto a lesser extentprogression to MIBC.EU guidelines recommend standard induction therapy with once-weekly BCG instillation
3、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.,Patients,Patients from the out
4、patient clinics of the participating centres(18) with high-risk NMIBC were randomised between October 1999 and April 2007 in Spain.,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 main
5、tenance therapy with a single instillation every 3 mo for 3 yr (a total of 18 instillations).,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 St
6、udents t test and x2 and log-rank tests.,Results,Results,Results,Results,Toxicity : 20 (10%) .,Recurrence in 40 (20%).,other reasons in 71 (35.5%). (48 received ten or more BCG instillations),Results,local side effects(safety population): frequency (65% of patients; NM 58%; M,71%), dysuria (63%; NM
7、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 prog
8、ression.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.In this study we did not observe decreases in recurrence and progression r
9、ates compared with induction therapy alone. This problem is expecting for further research.,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.,End,THANK YOU,
