Recirculating hyperthermic intravesical chemotherapy with mitomycin C (HIVEC) versus BCG in high-risk non-muscle-invasive bladder cancer: results of the HIVEC-HR randomized clinical trial
Purpose The purpose of the study was to compare the outcomes of high-risk non-muscle-invasive bladder cancer (HRNMIBC) patients treated with BCG vs recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC). Methods A pilot phase II randomized clinical trial was conducted in...
| Autores: | , , , , , , |
|---|---|
| Tipo de documento: | artigo |
| Data de publicação: | 2022 |
| País: | España |
| Recursos: | Universidad de Navarra |
| Repositório: | Dadun. Depósito Académico Digital de la Universidad de Navarra |
| Idioma: | inglês |
| OAI Identifier: | oai:dadun.unav.edu:10171/116842 |
| Acesso em linha: | https://hdl.handle.net/10171/116842 |
| Access Level: | Acceso aberto |
| Palavra-chave: | Bacillus Calmette–Guérin Bladder cancer Hyperthermia Progression Recurrence |
| Resumo: | Purpose The purpose of the study was to compare the outcomes of high-risk non-muscle-invasive bladder cancer (HRNMIBC) patients treated with BCG vs recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC). Methods A pilot phase II randomized clinical trial was conducted including HR-NMIBC patients, excluding carcinoma in situ. Patients were randomized 1:1 to receive intravesical BCG for 1 year (once weekly for 6 weeks plus subsequent maintenance) or HIVEC with 40 mg MMC, administered using the Combat BRS system (once weekly instillations were given for 6 weeks, followed by once monthly instillation for 6 months). Total recirculating dwell time for HIVEC was 60 min at a target temperature of 43°±0.5 °C. Primary endpoint was recurrence-free survival. Secondary endpoints were time to recurrence, progression-free survival, cancer-specifc survival, and overall survival at 24 months. Adverse events were routinely assessed. Results Fifty patients were enrolled. Mean age was 73.5 years. Median follow-up was 33.7 months. Recurrence-free survival at 24 months was 86.5% for HIVEC and 71.8% for BCG (p=0.184) in the intention-to-treat analysis and 95.0% for HIVEC and 75.1% for BCG (p=0.064) in the per protocol analysis. Time to recurrence was 21.5 and 16.1 months for HIVEC and BCG, respectively. Progression-free survival for HIVEC vs BCG was 95.7% vs 71.8% (p=0.043) in the intention-to-treat analysis and 100% vs 75.1% (p=0.018) in the per protocol analysis, respectively. Cancer-specifc survival at 24 months was 100% for both groups and overall survival was 91.5% for HIVEC vs 81.8% for BCG. Conclusion HIVEC provides comparable safety and efcacy to BCG and is a reasonable alternative during BCG shortages. Trial registration EudraCT 2016-001186-85. Date of registration: 17 March 2016. |
|---|