140 likes | 286 Views
Single immediate postoperative instillation of chemotherapy in patients with Ta/T1 bladder TCC. Dr Charles Chabert. Background. 70-80% present with superficial disease BCG treatment of choice if high risk 50% recurrence but < 5% progression. Sylvester et al J Urol 171, June 2004. Background.
E N D
Single immediate postoperative instillation of chemotherapy in patients with Ta/T1 bladder TCC Dr Charles Chabert
Background 70-80% present with superficial disease BCG treatment of choice if high risk 50% recurrence but < 5% progression Sylvester et al J Urol 171, June 2004
Background EAU guidelines recommend single dose ? Value in low risk & multiple tumours Sylvester et al J Urol 171, June 2004
Materials & methods Randomised trials with primary or recurrent Ta/T1 Exclusion of CIS Sylvester et al J Urol 171, June 2004
Materials & Methods Primary end point: % of patients with a recurrence in the 2 treatment arms Decrease in Odds of recurrence calculated without time to recurrence Sylvester et al J Urol 171, June 2004
Results 12 trials considered 5 exclusions; 4 inadequate randomisation 1 included CIS 7 trials entered into Meta-analysis Sylvester et al J Urol 171, June 2004
Trial Characteristics Accural between 1981-1994 Median F/U: 3.4 years (2-10.7 yrs) 3 trials included only primary patients 2 trials only single tumours Sylvester et al J Urol 171, June 2004
Trial Characteristics 4 different drugs used Epirubicin 3 trials Mitomycin C 2 trials Thiotepa 1 trial Pirarubicin 1 trial Sylvester et al J Urol 171, June 2004
Patient Characteristics 1517 eligible patients from 7 trials 1476 had F/U 748 (50.7%) TUR only & 728 (49.3%) TUR + instillation Sylvester et al J Urol 171, June 2004
Tumour Characteristics Predominantly low risk 89.2% primary tumours 84.3% single tumours 67.9% Ta 9.5% G3 Sylvester et al J Urol 171, June 2004
Recurrence 629 (42.6%) of 1476 patients 362 (48.4%) TUR & 267 (36.7%) TUR + Chemo Decrease of 39% in odds of recurrence Sylvester et al J Urol 171, June 2004
Recurrence Treatment effect similar for all agents No benefit with Thiotepa 849 single tumours: (41.5%) 47.5% TUR & 35.8% TUR + Chemo 111 multiple tumours: (74.8%) 81.5% TUR & 65.2% TUR + chemo Sylvester et al J Urol 171, June 2004
Toxicity Mild irritative bladder symptoms in 10% Systemic toxicity extremely rare Allergic skin reactions 1-3% Sylvester et al J Urol 171, June 2004
Summary NNT to prevent 1 recurrence: 8.5 One instillation cost effective Significantly reduces recurrence with minimal morbidity Sylvester et al J Urol 171, June 2004