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Initial experience with sequential BCG / Electro-motive drug administration (EMDA) Mitomycin-C (MMC) as the standard intravesical regimen for high risk p50 non-muscle invasive bladder cancer (NMIBC) Suzanne Amery, Kathryn Chatterton, Grace Zisengwe, Audrey Mukwahuri, Francis Dickinson, Shamim Khan, Kay Thomas, Tim O’Brien. The Urology Centre, Guy's and St Thomas‘ NHS Foundation Trust, London, UK Introduction MMC and BCG are effective treatments for NMIBC, however, they are rarely used in combination. Trials suggest they may be synergistic and that MMC is more effective if delivered by EMDA. In June 2009 we introduced sequential BCG/EMDA MMC as our standard induction regimen in high risk NMIBC. Methods 62 patients were identified. 46/62 (74%) new diagnosis TCC. TNM: high grade pTa/ pT1 (n=45); pTis (n=12); secondary CIS (n=15); other n=5. Mean age 70 (range 42 - 85) (56 males/6 females). 3 Weekly Treatment cycle – 2 weeks BCG (81mg); EMDA / MMC (40mg, intravesical electric current 20 mA / 30mins) Week 1 BCG 2 3 BCG EMDA / MMC 4 BCG 5 6 BCG EMDA / MMC 7 BCG 8 9 BCG EMDA / MMC GA check cystoscopy 8/52 post induction Following treatment patients were re-assessed for response rate, recurrence and tolerability. Complete responders were offered maintenance BCG alone. Results 62 Side-effects of treatment (n= 9), unrelated illness (n=3), BCGosis (n=1), rash (n=1), refused (n=1), unable to catheterise (n=1) patients Completed induction Reasons for incomplete induction Table 1 Incomplete induction (Table 1) 46 (74%) 16 (26%) (2 await 1st check, 1 defaulted) (4 await 1st check) Table 2 st Recurrence at 1 check completing full induction Initial Histology 3/12 recurrence Treatment G3 pT1 G3 pT1 Cystectomy (pT0) Completed initial check Completed initial check G3 pTa + CIS pTis BCG 43 12 G3 pT1 G3 pT2 Cystectomy (pT2b, N0) G2 (high) pTa + CIS G2 (high) pTa G2 (high) pTa Synergo G2 (high) pTa Endoscopic review G2 (high) pTa pTis BCG G2 (high) pTa G2 (low) pTa BCG pTis pTis BCG No recurrence Recurrence (Table 2) 35 (81%) 8 (19%) No recurrence 10 (83%) Recurrence 2 (17%) (4 await 12mth check) (11 await 12mth check) Table 3 Disease free at 12mths 21 (88%) Recurrence (Table 3) 3 (12%) Disease free at 12mths Recurrence 5 (83%) 1 (17%) Key Findings 45/55 (82%) disease free at 3/12 Clear at 3/12, recurrence at 12/12 Initial Histology 12/12 recurrence Treatment G3 pT1 G2 (high) pTa Endoscopic review G3 pT1 pTis Cystectomy (pT0) pTis G3 pT1 Cystectomy (pTa + CIS, N0) 26/30 (87%) remain disease free at 12/12 26% of patients could not complete all 9 induction doses Conclusion Sequential BCG/EMDA MMC can be very challenging to administer with 26% of patients not completing the schedule, however irrespective of completion it appears to deliver excellent oncological control in NMIBC.