التفاصيل البيبلوغرافية
| العنوان: |
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 |
| المؤلفون: |
Guerrero-Ramos, Félix, González-Padilla, Daniel A., González-Díaz, Alejandro, de la Rosa-Kehrmann, Federico, Rodríguez-Antolín, Alfredo, Inman, Brant A., Villacampa-Aubá, Felipe |
| المصدر: |
World Journal of Urology ; volume 40, issue 4, page 999-1004 ; ISSN 1433-8726 |
| بيانات النشر: |
Springer Science and Business Media LLC |
| سنة النشر: |
2022 |
| مصطلحات موضوعية: |
Urology |
| الوصف: |
Purpose 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). 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-specific 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-specific 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 efficacy to BCG and is a reasonable alternative during BCG shortages. Trial registration EudraCT 2016-001186-85. Date of registration: 17 March 2016. |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.1007/s00345-022-03928-1 |
| DOI: |
10.1007/s00345-022-03928-1.pdf |
| DOI: |
10.1007/s00345-022-03928-1/fulltext.html |
| الإتاحة: |
https://doi.org/10.1007/s00345-022-03928-1Test |
| حقوق: |
https://creativecommons.org/licenses/by/4.0Test ; https://creativecommons.org/licenses/by/4.0Test |
| رقم الانضمام: |
edsbas.1BCF588 |
| قاعدة البيانات: |
BASE |
