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.

The purpose of the study was to compare the outcomes of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) patients treated with BCG vs recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC).

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-specific survival, and overall survival at 24 months. Adverse events were routinely assessed.

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-specific survival at 24 months was 100% for both groups and overall survival was 91.5% for HIVEC vs 81.8% for BCG.

HIVEC provides comparable safety and efficacy to BCG and is a reasonable alternative during BCG shortages.

EudraCT 2016-001186-85. Date of registration: 17 March 2016.

World journal of urology. 2022 Jan 17 [Epub ahead of print]

Félix Guerrero-Ramos, Daniel A González-Padilla, Alejandro González-Díaz, Federico de la Rosa-Kehrmann, Alfredo Rodríguez-Antolín, Brant A Inman, Felipe Villacampa-Aubá

Department of Urology, Hospital Universitario 12 de Octubre, Avenida de Córdoba s/n, 28041, Madrid, Spain. ., Department of Urology, Hospital Universitario 12 de Octubre, Avenida de Córdoba s/n, 28041, Madrid, Spain., Division of Urology, Duke University Medical Center, Durham, NC, USA., Department of Urology, Clínica Universidad de Navarra, Madrid, Spain.

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