Toxicity did not go beyond grade 2 except in five cases. At a median follow-up of 41 months, recurrence and progression rates were 35.3 and 23.5%, respectively. 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. Thirty-four eligible patients entered the study between January 2009 and April 2011. Kaplan-Meier estimation of the time to recurrence and progression, cancer-specific survival and overall survival was taken as secondary end points. Any grade 3 and/or muscle-invasive (T > 1) recurrence was considered disease progression. Primary end points were treatment safety and response rate (RR), and the latter defined as the absence of any unfavourable outcome at 12 months. ![]() Six weekly instillations with Unithermia(®) were scheduled following complete TUR. 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. 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).
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