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
Sources of Funding: None
Until October 2014, our standard bladder-sparing treatment for high risk (HR) non-muscle invasive bladder cancer (NMIBC) was a full-dose intravesical bacillus Calmette-Guerin (BCG) 6-week induction course and maintenance BCG for 1-3 years. In response to the BCG shortage, we modified our regimen to sequential full-dose BCG and device-assisted chemo-hyperthermia (Mitomycin C [MMC] delivered by the Combat BRS system). Here we present our 1-year results after start of treatment.
The 6-week induction regimen became BCG (weeks 1,2), Combat BRS (weeks 3,4,5) and BCG (week 6). Nine further Combat BRS maintenance treatments were given by 1 year comprising 3 sets of weekly instillations for 3 weeks. We reviewed the 1-year follow-up results of 50 HR-NMIBC (high grade [grade 3] and/or carcinoma in situ [CIS]) patients who commenced treatment between October 2014 and September 2015. T1 tumours represented 62% of cases and were routinely re-resected. CIS was detected in 40% of cases. We excluded 11 patients from this series who had concurrent upper urinary tract or prostatic urothelial tumours, previous radiotherapy or BCG or a course of MMC.
Of 50 patients, 44 (88%) were disease-free by 1 year; 3 (6%) had refractory HR-NMIBC at 6 months, 2 (4%) progressed to MIBC by 6 months and 1 (2%) presented with metastatic disease at 1 year. All 6 had CIS and/or T1 at diagnosis. Forty-three patients (86%) tolerated Combat BRS treatment; 2 reacted with rashes during maintenance and 5 had bladder-related tolerability issues.
Our oncological results with sequential BCG/Combat BRS at 1 year are at least comparative at this time-point with those expected for HR-NMIBC patients on maintenance BCG. Tolerability and compliance shows great promise.
William JF Green
Peter T Grice
Jonathan C Goddard
Roger C Kockelbergh