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01.02.2016 | Original Article

Efficacy and safety of a new device for intravesical thermochemotherapy in non-grade 3 BCG recurrent NMIBC: a phase I–II study

verfasst von: Francesco Soria, Paola Milla, Chiara Fiorito, Francesca Pisano, Filippo Sogni, Massimiliano Di Marco, Vincenzo Pagliarulo, Franco Dosio, Paolo Gontero

Erschienen in: World Journal of Urology | Ausgabe 2/2016

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Abstract

Purpose

We report for the first time the activity and safety of Unithermia^® (Elmedical Ltd, Hod-Hasharon, Israel), a novel device for administration of MMC-C with hyperthermia (HT), that employs conductive heating, in a series of non-grade 3 non-muscle-invasive bladder cancer (NMIBC) that failed Bacillus Calmette–Guerin (BCG).

Methods

Patients with non-grade 3 NMIBC recurring after at least a full induction course of BCG were eligible for this phase I–II prospective single-arm study. Six weekly instillations with Unithermia^® were scheduled following complete TUR. Primary end points were treatment safety and response rate (RR), and the latter defined as the absence of any unfavourable outcome at 12 months. Any grade 3 and/or muscle-invasive (T > 1) recurrence was considered disease progression. Kaplan–Meier estimation of the time to recurrence and progression, cancer-specific survival and overall survival was taken as secondary end points.

Results

Thirty-four eligible patients entered the study between January 2009 and April 2011. RR was documented in 20/34 (59 %). Among the 14/34 (41 %) non-responders, four developed G3 disease, one developed carcinoma in situ, and one progressed to muscle-invasive bladder cancer, with an overall 18 % progression rate at 1 year. At a median follow-up of 41 months, recurrence and progression rates were 35.3 and 23.5 %, respectively. Toxicity did not go beyond grade 2 except in five cases.

Conclusions

Initial experience with MMC-HT with Unithermia^® showed an interesting activity and safety profile in non-grade 3 NMIBC recurring after BCG, suggesting a role as second-line therapy in this selected subgroup of NMIBC.

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Titel: Efficacy and safety of a new device for intravesical thermochemotherapy in non-grade 3 BCG recurrent NMIBC: a phase I–II study
verfasst von: Francesco Soria
Paola Milla
Chiara Fiorito
Francesca Pisano
Filippo Sogni
Massimiliano Di Marco
Vincenzo Pagliarulo
Franco Dosio
Paolo Gontero
Publikationsdatum: 01.02.2016
Verlag: Springer Berlin Heidelberg
Erschienen in: World Journal of Urology / Ausgabe 2/2016
Print ISSN: 0724-4983
Elektronische ISSN: 1433-8726
DOI: https://doi.org/10.1007/s00345-015-1595-3

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Efficacy and safety of a new device for intravesical thermochemotherapy in non-grade 3 BCG recurrent NMIBC: a phase I–II study