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.

BACKGROUND: There is no effective intravesical second-line therapy for non-muscle-invasive bladder cancer (NMIBC) when bacillus Calmette-Guérin (BCG) fails. OBJECTIVE: 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. DESIGN, SETTINGS, AND PARTICIPANTS: Open-label, phase III randomised controlled trial accrued across 14 centres between May 2010 and July 2013 (HYMN [ClinicalTrials.gov: NCT01094964]). INTERVENTION: 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. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: 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. RESULTS AND LIMITATIONS: 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. CONCLUSIONS: 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. PATIENT SUMMARY: 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.

5-year outcome of a prospective randomized trial to compare transurethral electrovaporization of the prostate and standard transurethral resection.

OBJECTIVES: To update our prospective randomized trial comparing the safety, efficacy, and durability of transurethral electrovaporization of the prostate (TUVP) using the VaporTrode with standard transurethral resection of the prostate (TURP). METHODS: A total of 104 patients, taken from the waiting list for surgery for benign prostatic hyperplasia were randomized to TUVP (52 patients, mean age 67.5 years) or TURP (52 patients, mean age 70.2 years). In each group, 51, 47, and 40 patients completed 1, 2, and 3 years of follow-up, respectively. Of the 104 patients, 27 TURP and 26 TUVP patients completed 5 years of follow-up. RESULTS: Both groups were comparable in terms of the mean preoperative International Prostate Symptom Score, quality-of-life score, maximal urinary flow rate, and postvoid residual volume. The follow-up data at 5 years showed a significant and maintained improvement in the mean International Prostate Symptom Score (TUVP: 5.9 +/- 6.3 versus TURP: 8.6 +/- 7.1, P = 0.16), quality-of-life score (TUVP: 1.1 +/- 1.2 versus TURP: 1.7 +/- 1.4, P = 0.09), and mean maximal urinary flow rate (TUVP: 21 +/- 9 mL/s versus TURP: 17.9 +/- 13.1 mL/s, P = 0.17), with decreases in the mean postvoid residual volume (TUVP: 27.3 +/- 44.3 mL versus TURP: 10.7 +/- 13.1 mL, P = 0.08). Two patients in each group (4%) developed urethral strictures. Two TURP patients (4%) developed bladder neck strictures compared with one TUVP patient (2%). In each arm, 7 patients (13%) underwent reoperation during a 5-year period (approximate reoperation rate: 3% in each arm per year). Postoperatively and during 3 years of follow-up, impotence was reported in 17% of the TUVP group and 11% of the TURP group (P = 0.49); retrograde ejaculation was reported in 72% of the TUVP group and 89% of the TURP group (P = 0.47). CONCLUSIONS: Our 5-year follow-up results confirm that TUVP is as effective as standard TURP in the treatment of moderate-size benign prostatic hyperplasia. The reoperation rate and long-term complication rate are comparable and the initial improvement has been maintained during a 5-year period for most patients in both groups.