Presentation Authors: Wei Shen Tan*, London , United Kingdom, Kees Hendricksen, Amsterdam, Netherlands, Dan Wilby, Portsmouth, United Kingdom, Cajetan Nzeh, Gladbeck, Germany, Javier Goizueta, Madrid, Spain, Wolfgang Vilmar, Nuremberg, Germany, Ana Bello, Tenerife, Spain, Alejandro Sousa, Lugo, Spain, J Morena, Madrid, Spain, Jose Pontones, Valencia, Spain, Felix Guerrero, Madrid, Spain, Iliya Kalchev, Sofia, Bulgaria, Eric Frank, Aachen, Germany, Joost Boormans, Rotterdam, Netherlands
Introduction: Intravesical BCG with maintenance is recommended for patients with high-risk non-muscle invasive bladder cancer (NMIBC). However, there remains no bladder sparing option in patients with persistent or early recurrent disease following adequate BCG treatment. We report oncological outcomes of patients with BCG unresponsive disease who were treated with conductive chemohyperthermia (CHT).
Methods: We utilised a multicentre European retrospective patient cohort of patients treated with the Combat BRS system. Each treatment instillation comprised of MMC with hyperthermia delivered at 43Â°C over 60 minutes. BCG-unresponsive NMIBC (urothelial carcinoma) was defined as papillary disease Â± carcinoma in situ (CIS) within 12 months of last instillation of adequate BCG, or recurrent high grade papillary disease within 6 months of last instillation of adequate BCG therapy, or stage T1 disease at first 3 month cystoscopy following induction BCG. Primary endpoint was the 12-month recurrence-free survival (RFS) and the progression-free survival (PFS).
Results: A total of 87 patients from 14 European institutions met the criteria for BCG-unresponsive disease. Median patient age was 73.3 years (64.0-79.1) with male patients comprising of 77 patients (88.5%). A total of 23 patients (26.4%) had CIS only disease, 52 patients (59.8%) with papillary only disease and 12 patients (13.8%) with concurrent CIS and papillary disease. Of the 64 patients with papillary disease, 35 patients (54.7%) had Ta and 29 patients (45.3%) T1 NMIBC. Sixty six patients (75.9%) had high-risk disease. With a median follow-up of 15 (IQR: 8-29) months, 44 patients developed disease recurrence. RFS at 12 months was 55% and at 24 months was 48%. PFS at 24 months was 95%. In patients with CIS disease, 6-month complete response rate was 57% and only one patient had disease progression.
Conclusions: BCG-unresponsive NMIBC patients who are treated with CHT delivered using the Combat BRS system had a 24-month DFS of 48% and PFS of 95%. CHT may be an option in NMIBC patients who are unresponsive to BCG.