Radiofrequency-induced Thermo-chemotherapy Effect Versus a Second Course of Bacillus Calmette-Guérin or Institutional Standard in Patients with Recurrence of Non-muscle-invasive Bladder Cancer Following Induction or Maintenance Bacillus Calmette-Guérin Th

There is no effective intravesical second-line therapy for non-muscle-invasive bladder cancer (NMIBC) when bacillus Calmette-Guérin (BCG) fails.

To compare disease-free survival time (DFS) between radiofrequency-induced thermo-chemotherapy effect (RITE) and institutional standard second-line therapy (control) in NMIBC patients with recurrence following induction/maintenance BCG.

Open-label, phase III randomised controlled trial accrued across 14 centres between May 2010 and July 2013 (HYMN [ClinicalTrials.gov: NCT01094964]).

Patients were randomly assigned (1:1) to RITE (60min, 40mg mitomycin-C, 42±2°C) or control following stratification for carcinoma in situ (CIS) status (present/absent), therapy history (failure of previous induction/maintenance BCG), and treatment centre.

Primary outcome measures were DFS and complete response (CR) at 3 mo for the CIS at randomisation subgroup. Analysis was based on intention-to-treat.

A total of 104 patients were randomised (48 RITE: 56 control). Median follow-up for the 31 patients without a DFS event was 36 mo. There was no significant difference in DFS between treatment arms (hazard ratio [HR] 1.33, 95% confidence interval [CI] 0.84-2.10, p=0.23) or in 3-mo CR rate in CIS patients (n=71; RITE: 30% vs control: 47%, p=0.15). There was no significant difference in DFS between treatment arms in non-CIS patients (n=33; RITE: 53% vs control: 24% at 24 mo, HR 0.50, 95% CI 0.22-1.17, p=0.11). DFS was significantly lower in RITE than in control in CIS with/without papillary patients (n=71; HR 2.06, 95% CI 1.17-3.62, p=0.01; treatment-subgroup interaction p=0.007). Disease progression was observed in four patients in each treatment arm. Adverse events and health-related quality of life between treatment arms were comparable.

DFS was similar between RITE and control. RITE may be a second-line therapy for non-CIS recurrence following BCG failure; however, confirmatory trials are needed. RITE patients with CIS with/without papillary had lower DFS than control. HYMN highlights the importance of the control arm when evaluating novel therapies.

This study did not show a difference in bladder cancer outcomes between microwave-heated chemotherapy and standard of care treatment. Papillary bladder lesions may benefit from microwave-heated chemotherapy treatment; however, more research is needed. Both treatments are similarly well tolerated.

European urology. 2018 Sep 28 [Epub ahead of print]

Wei Shen Tan, Anesh Panchal, Laura Buckley, Adam J Devall, Laurence S Loubière, Ann M Pope, Mark R Feneley, Jo Cresswell, Rami Issa, Hugh Mostafid, Sanjeev Madaan, Rupesh Bhatt, John McGrath, Vijay Sangar, T R Leyshon Griffiths, Toby Page, Dominic Hodgson, Shibendra N Datta, Lucinda J Billingham, John D Kelly

Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital, London, UK., Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK., Department of Urology, University College London Hospital, London, UK., Department of Urology, James Cook University Hospital, Middlesbrough, UK., Department of Urology, St George's Hospital, London, UK., Department of Urology, Royal Surrey County Hospital, Guildford, UK., Department of Urology, Darent Valley Hospital, Dartford, UK., Department of Urology, Queen Elizabeth Hospital, Birmingham, UK., Department of Urology, Royal Devon and Exeter Hospital, Exeter, UK., Department of Urology, Withington Hospital, Manchester, UK., Department of Urology, Leicester General Hospital, Leicester, UK., Department of Urology, Freeman Hospital, Newcastle Upon Tyne, UK., Department of Urology, Queen Alexandra Hospital, Portsmouth, UK., Department of Urology, University Hospital of Wales, Cardiff, UK., Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital, London, UK. Electronic address: .

E-Newsletters

Newsletter subscription

Free Daily and Weekly newsletters offered by content of interest

The fields of GU Oncology and Urology are rapidly advancing. Sign up today for articles, videos, conference highlights and abstracts from peer-review publications by disease and condition delivered to your inbox and read on the go.

Subscribe