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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.

Publication ,  Journal Article
Guerrero-Ramos, F; González-Padilla, DA; González-Díaz, A; de la Rosa-Kehrmann, F; Rodríguez-Antolín, A; Inman, BA; Villacampa-Aubá, F
Published in: World journal of urology
April 2022

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.

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Published In

World journal of urology

DOI

EISSN

1433-8726

ISSN

0724-4983

Publication Date

April 2022

Volume

40

Issue

4

Start / End Page

999 / 1004

Related Subject Headings

  • Urology & Nephrology
  • Urinary Bladder Neoplasms
  • Neoplasm Recurrence, Local
  • Mitomycin
  • Hyperthermia, Induced
  • Humans
  • BCG Vaccine
  • Aged
  • Administration, Intravesical
  • Adjuvants, Immunologic
 

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Guerrero-Ramos, F., González-Padilla, D. A., González-Díaz, A., de la Rosa-Kehrmann, F., Rodríguez-Antolín, A., Inman, B. A., & Villacampa-Aubá, F. (2022). 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. World Journal of Urology, 40(4), 999–1004. https://doi.org/10.1007/s00345-022-03928-1
Guerrero-Ramos, Félix, Daniel A. González-Padilla, Alejandro González-Díaz, Federico de la Rosa-Kehrmann, Alfredo Rodríguez-Antolín, Brant A. Inman, and Felipe Villacampa-Aubá. “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.World Journal of Urology 40, no. 4 (April 2022): 999–1004. https://doi.org/10.1007/s00345-022-03928-1.
Guerrero-Ramos F, González-Padilla DA, González-Díaz A, de la Rosa-Kehrmann F, Rodríguez-Antolín A, Inman BA, et al. 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. World journal of urology. 2022 Apr;40(4):999–1004.
Guerrero-Ramos, Félix, et al. “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.World Journal of Urology, vol. 40, no. 4, Apr. 2022, pp. 999–1004. Epmc, doi:10.1007/s00345-022-03928-1.
Guerrero-Ramos F, González-Padilla DA, González-Díaz A, de la Rosa-Kehrmann F, Rodríguez-Antolín A, Inman BA, Villacampa-Aubá F. 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. World journal of urology. 2022 Apr;40(4):999–1004.
Journal cover image

Published In

World journal of urology

DOI

EISSN

1433-8726

ISSN

0724-4983

Publication Date

April 2022

Volume

40

Issue

4

Start / End Page

999 / 1004

Related Subject Headings

  • Urology & Nephrology
  • Urinary Bladder Neoplasms
  • Neoplasm Recurrence, Local
  • Mitomycin
  • Hyperthermia, Induced
  • Humans
  • BCG Vaccine
  • Aged
  • Administration, Intravesical
  • Adjuvants, Immunologic