RITE Thermochemotherapy in the treatment of BCG refractory NMIBC
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1 RITE Thermochemotherapy in the treatment of BCG refractory NMIBC Ben Ayres Consultant Urological Surgeon St George s Hospital London 1
2 Financial and Other Disclosures Off-label use of drugs, devices, or other agents: None Data from IRB-approved human research is presented I have the following financial interests or relationships to disclose: Olympus Pfzier Minerini Disclosure code L L L 2
3
4 BCG failure International consensus panel 2005 (Nieder AM et al, Urology ) 2005 BCG refractory Failure to achieve a disease-free state by 6 months after initial BCG therapy with either maintenance or retreatment at 3 months because of either persistent or rapidly recurrent disease Any progression in stage, grade or disease extent by 3 months after induction BCG Genitourinary cancer symposium Orlando Feb 2015 BCG unresponsive (Lerner SP et al, Bl Cancer 2015; Kamat AM et al, JCO 2016) Persistent or recurrent high grade disease within 6 months of BCG treatment (at least 2 courses) or High grade recurrence 6 months after last dose of BCG if initial CR (at least 2 courses) or High grade T1 recurrence 4
5 BCG failure BCG-resistant disease: recurrence or persistence of disease at 3 months after induction. It is of lesser degree, stage, or grade, and is no longer present at 6 months from BCG retreatment with or without TUR "i.e. disease improves then resolves with further BCG BCG-relapsing disease: recurrence of disease after achieving a disease-free status by 6 months. Subdivided into: early (within 12 months) intermediate (12 to 24 months) late (>24 months) BCG-intolerant disease: recurrence after an incomplete course of therapy is applied because of a serious adverse event or symptomatic intolerance that results in discontinuation of BCG. 5
6 RITE Thermochemotherapy Nativ O et al J Urol 2009 n=111 BCG failure 26%T1 No CIS 38%BCG refractory -1yr recurrence free survival 85% -2yr recurrence free survival 56% 3%progressed to muscle invasion 6
7 RITE Thermochemotherapy Arends TJH et al J Urol 2014 n=160 47%T1 62.5%high risk NMIBC (EAU) 81%previous BCG treatment -1yr recurrence-free survival 60% -2yr recurrence-free survival 47% 4%progressed to muscle invasion 7
8 St George s experience Majority BCG failure Large number with CIS Majority frail / elderly Pre-treatment cystoscopy, cytology, CT scan Strict follow-up with biopsies Dedicated urologists (2) / pathologist
9
10 Demographics n=64 84% male Median age 74 years (68-78) 100% high risk NMIBC 25% G3pT1 with CIS 22% G3pTa with CIS 41% CIS only 5% G3pT1 8% G3pTa 100% BCG failure 39% BCG refractory 55% BCG unresponsive Median follow up 47 months (38-58)
11 Recurrence recurrence free survival yr recurrence free survival 70% 2-yr recurrence free survival 53% recurrence free survival (high grade recurrence) yr recurrence free survival 76% 2-yr recurrence free survival 58%
12 Recurrence recurrence free survival yr recurrence free survival 70% 2-yr recurrence free survival 53% BCG unresponsive recurrence free survival yr recurrence free survival 74% 2-yr recurrence free survival 54%
13 Progression progression free survival yr progression free survival 94% 2-yr progression free survival 80% BCG unresponsive progression free survival yr progression free survival 91% 2-yr progression free survival 80%
14 Survival overall survival Cancer specific survival
15 Further treatment 25% cystectomy (all alive) 2 prostatic urethra stromal disease 4 muscle invasive disease 10 persistent CIS 5% chemoradiotherapy (1 died) 2 muscle invasive disease 1 prostatic urethra stromal disease 8% upper tract TCC 6% developed metastases
16
17 Disease specific survival after radical cystectomy for recurrent high-risk NMIBC after BCG failure Solsona E et al. BJU Int. 2004;. 94: Cancer specific survival RITE
18 Summary RITE Thermochemotherapy has an important role to play in treating BCG failures 2-yr recurrence free survival 53% 2-yr progression free survival 80% Careful patient selection and surveillance very important Consider alternative treatment early if not complete response CIS may persist and require cystectomy Survival comparable to BCG failure cystectomy series
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