PD19-07 ONE-YEAR FOLLOW-UP RESULTS AFTER SEQUENTIAL INTRAVESICAL BACILLUS CALMETTE-GUÉRIN AND DEVICE-ASSISTED CHEMO-HYPERTHERMIA (MITOMYCIN C DELIVERED BY THE COMBAT BRS SYSTEM) FOR HIGH RISK NON-MUSCLE INVASIVE BLADDER CANCER PATIENTS...A BACILLUS CALMETTE-GUÉRIN-SPARING STRATEGY

AND OBJECTIVES: Sequential BCG/EMDAMMC was previously reported to be superior to BCG alone, and since 2009, has been the standard induction regimen in our institution for the treatment of HR-NMIBC. We now present medium-term outcomes from this study. METHODS: From June 2009 to June 2013, all patients undergoing bladder conservation for HR-NMIBC were offered sequential BCG/EMDA-MMC. BCG (Immucyst until June 2012, Oncotice since Sept 2012) was given in weeks 1 and 2, and EMDA-MMC (40mg, intravesical current 20mA for 30 mins) in week 3, and this cycle was repeated 3 times for a total of 9 weeks. Maintenance treatment was with 3 doses of BCG every 6 months, commencing 3 months after induction. Response was assessed by GA cystoscopy 8 weeks post induction, followed by 6-monthly flexible cystoscopy. RESULTS: 151 patients with HR-NMIBC were treated, of whom 44 (29%) received primary cystectomy, leaving 107 patients (71%) treated with sequential BCG/EMDA-MMC. 86/107 (80%) had high grade Ta/T1 disease, of whom 34 (32%) also had carcinoma in situ (CIS). 19/107 (18%) had primary CIS. 2 (2%) had recurrent, large volume, low grade disease. Median length of follow-up was 47 months (range 4-87 months). 1 patient was lost to follow-up immediately after induction and was excluded from analysis. Overall, 37/106 (35%) patients had disease recurrence. 7/106 (7%) had disease progression, of whom 2/106 (2%) progressed to higher stage NMIBC, 3/106 (3%) progressed to muscle invasive bladder cancer (MIBC), and 2/106 (2%) developed distant metastases. 11/106 (10%) eventually underwent cystectomy for the following reasons: progression to MIBC (3/11), disease recurrence (7/11) and severe bladder storage symptoms (1/11). 17/106 patients (16%) have died, of which 2/106 (2%) died from bladder cancer. As previously reported, 30/107 patients were unable to complete the full 9-dose induction schedule, 16/30 directly due to side effects. There was no significant difference in recurrence rates between patients who received a full (36%) versus a reduced (30%) induction schedule (X21⁄40.39, p1⁄40.53). CONCLUSIONS: Despite the challenge of a 4-year recurrence rate of 35%, a low progression rate to muscle-invasive and metastatic disease of 5% and disease-specific mortality of 2% continue to attest to the oncological efficacy of sequential BCG/EMDA-MMC.