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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

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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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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical standard

The study has been approved by Ethics Committee on 01/09/2008 (Protocol No. 0065331). The study has been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. All the enrolled patients gave their informed consent before the inclusion in the study.

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Author notes

    Authors and Affiliations

    1. Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, C.so Bramante 88/90, 10126, Turin, Italy

      Francesco Soria, Chiara Fiorito, Francesca Pisano & Paolo Gontero

    2. Department of Pharmacology, University of Studies of Torino, Turin, Italy

      Paola Milla & Franco Dosio

    3. Urology Clinic, Maggiore della Carità Hospital, Novara, Italy

      Filippo Sogni

    4. Urology Unit, Casa di Cura Guarnieri, Rome, Italy

      Massimiliano Di Marco

    5. Urology Clinic, Policlinico of Bari, Bari, Italy

      Vincenzo Pagliarulo

    Authors
    1. Francesco Soria
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    2. Paola Milla
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    3. Chiara Fiorito
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    4. Francesca Pisano
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    8. Franco Dosio
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    9. Paolo Gontero
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    Correspondence to Paolo Gontero.

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    All the authors have contributed equally to this work.

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    Soria, F., Milla, P., Fiorito, C. et al. Efficacy and safety of a new device for intravesical thermochemotherapy in non-grade 3 BCG recurrent NMIBC: a phase I–II study. World J Urol 34, 189–195 (2016). https://doi.org/10.1007/s00345-015-1595-3

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    • DOI: https://doi.org/10.1007/s00345-015-1595-3

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