The German study group of intravesical hyperthermia-chemotherapy in non-muscle-invasive bladder cancer presents their long-term results in efficacy and tolerability for optimized adjuvant therapy and bladder preservation.

Abstract

268 Background: In NMIBC recurrence and progression in high-risk BC are the dominant aspects for the clinical management. Intravesical chemotherapy and BCG treatment are the techniques to reduce both risks. HTC has a potentiating synergistic action in BC cell death induction. In consequence we proved HTC in the adjuvant indication and the ablativ indication in high-risk BC. Methods: We treated 138 patients in 1,443 treatment sessions in 3 institutions with intravesical hyperthermia-chemotherapy with Mitomycin C applied with the Synergo device. After an initial inductive weekly therapy for 6 to 8 weeks maintenance followed once every 6 weeks 6 times and cystoscopy every 3 month. Results: In the adjuvant indication 52 patients were treated. The over all recurrence free rate was 78.3% over 2.9 years in mean (3.6m – 6.9y). Only 10 patients recurred but none progressed or needed a cystectomy. In the ablative indication 86 patients were treated. For efficacy 69 could be evaluated. 17 patients must be excluded because of protocol violation or extra-vesical TCC or simultanious second malignancy. 85.5% of the patients (58) reached CR and this persited for 26.1 months in mean. 48 patients (69.6%) were tumor free over the hole investigation time. In total 8 patients (11.6%) needed a cystectomy. 3 patient (4.3%) progressed to metastatic disease and the other 5 demonstrated low-risk new tumors again treated transurethral. In total 53 patient (76.8%) achieved organ preservation in high-risk situation. Side effects included allergy, UTI, spasm, difficulties with catheterization and nocturia ascending from 1.4% to 5.6%. Conclusions: HTC is a safe and effective therapy in NMIBC to prevent intermediate risk BC patients for recurrence and to ensure organ preservation in high-risk BC patients in more than 75% with a long lasting efficacy.

Intravesical radiofrequency-induced hyperthermia combined with chemotherapy for non-muscle-invasive bladder cancer

“…Nonetheless, this does provide an impression of its general efficacy. Regarding recurrence, for example, rates vary from 16-89%, see also Table 1 in this paper as well as Table 1 from the systematic review of Lammers et al [11,[25][26][27][28][29][30][31][32][33]. Two outliers are seen in this range, both representing studies with patients not suitable and/or unwilling for cystectomy [29,34].…”

“…Progression is reported less often than recurrence, since it requires a longer follow-up of NMIBC. Nonetheless, some figures are published: overall 0-36% show progression, and when only studies with a follow-up of 42 years are considered, the same figures apply [11,[25][26][27][28][29][30][31][32][33]. Most of these studies define progression as occurrence of MIBC.…”

“…CR after ablative therapy ranges from 42-85.5%, with subsequent recurrence rates of 16-30.4% (follow-up ranging from 16-38 months). Progression rate for complete responders varies from 0% to 27% [11,25,26,[30][31][32]. See also Table 1.…”

“…See also Table 1. For prophylactic therapy, recurrence rate varies from 15.6-56% and progression rate from 0-11.9% (follow-up ranging from 10-38 months) [11,[25][26][27][28]31,33].…”

Thermochemotherapie mit Mitomycin C: Update zur Therapiealternative beim nicht-muskelinvasiven Harnblasenkarzinom

“…Die Ergebnisse ähneln der deutschen Studiengruppe von Lüdecke et al, der in der Hochrisikogruppe (davon 37 % mit Mitomycin C oder BCG vorbehandelt) nach 28 Monaten eine Rezidivfreiheit von 69 % zeigen konnte. Die Zahl der Rezidivpatienten, die dabei ein muskelinvasives Karzinom ausbildeten, war mit 4 % deutlich erniedrigt [24].…”