📃 Paper Title: 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 Therapy (HYMN): A Phase III, Open-label, Randomised Controlled Trial
🧍 Author: Tan
🕒 Year: 2018
📚 Journal: European Urology
🌎 Country: United Kingdom
ㅤContext to the study:
Can you tell me a randomised control trial that assessed the impact of radiofrequency-heated chemotherapy vs standard of care treatment in bladder cancer outcomes
ㅤ✅ Take-home message of study:
No difference in bladder cancer outcomes between microwave-heated chemotherapy and standard of care treatment.
No statistically significant difference in disease-free survival time in patients using RITE instead of the control and the complete response rate at 3 months in patients using RITE instead of the control
HYMN suggests the potential for RITE as a 2nd -line therapy for non-CIS recurrence following BCG; however, confirmatory trials are needed.
ㅤ Randomised control trial
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Study participants:
Study Size:
A total of 104 patients (48 RITE (Radiotherapy induced thermo-chemotherapy effect), 56 control (control treatment consisted of 6 consecutive weekly BCG instillations following by maintenance therapy.
Inclusion criteria:
Recurrence of intermediate or high-risk NMIBC following induction or maintenance BCG therapy
Age equal to or greater than 18
WHO performance status equal to or >4
Patients unfit or unwilling to have a radical cystectomy
Exclusion criteria:
Non-urothelial carcinoma
Low-grade NMIBC recurrence
Treatment with intravesical chemotherapy less than or equal to 6 months
Prostatic urethra or upper tract disease
Known Mitomycin-C allergy
UTI (active or intractable)
Urethral stricture
Small bladder capacity <250mls
Significant urinary incontinence
History of pelvic radiotherapy
Median follow up of 31 months for those without DFS event
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Key study outcomes:
Primary outcomes:
Disease-free survival time (DFS) : defined as the time from randomization to earliest detection of histologically confirmed recurrence, positive urinary cytology or death
RITE-treated patients with CIS with/without papillary had lower DFS than control.
3-month complete response (CR) for patients with biopsy-proven CIS at randomization - defined as the absence of visible tumour at cystoscopy, negative urinary cytology and no CIS on random bladder biopsy.
Secondary outcomes:
Progression free surgical time (PFS)
Overall survival time (OS)
Disease-specific survival time (DSS)
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Study Limitations:
Closed HYMN trial early due to a higher-than-expected CIS recurrence in RITE-treated patients.
Did not meet recruitment target
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