The protocol entailed a total of 8 weekly instillations of 80 mg of Mitomycin-c (MMC) diluted in 50ml of distilled water, recirculated through the bladder during one hour at a 43°C (+0.5°C). A complete TURBT was then performed and pathologic findings were analyzed. A total of 37 patients were treated in the Monforte Comarcal Hospital (Spain) between December 2010 and December 2016. Tolerance data were recorded and quality of life FACT-BI and IPSS questionnaires were completed. Follow up of patients varied from 6 to 78 months to detect any residual disease or long term complications.
The results showed that 96.3% (285 of 296) of the scheduled “HIVEC" neo adjuvant treatments were completed. The most frequent adverse events were only mild (Grade 1). Complete response (confirmed pathology) rate was 62.1% (n=23). Partial response (reduction of tumour load >50%) was 32.4% (n=12), and non-responder was 5.4% (n=2). The cumulative incidence of recurrence at 5 years was 26.1% (95%CI: 4.1% to 45.3%).
In conclusion, Combat-BRS has a favorable side effect profile. Neoadjuvant “HIVEC" treatment seems to be effective against NMIBC. It achieves the complete elimination of the tumor in two thirds of the treated patients and obtained a low number of relapses in up to 5 years of follow up. Additional randomized clinical trials are needed to clarify the use of this modality the clinical practice.
Presented by: Sousa-Escandón A.
Affiliation: Comarcal Hospital of Monforte, Monforte de Lemos, Spain
Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre.Twitter: @GoldbergHanan at the 37th Congress of Société Internationale d’Urologie - October 19-22, 2017- Lisbon, Portugal