Trial reportWorld journal of urology2022
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.
Trial report in World journal of urology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 59 citations in OpenAlex.
- Comparative efficacy of hyperthermic chemotherapy and BCG instillation in non-muscle invasive bladder cancer: a systematic review and meta-analysis.International urology and nephrology · 2026Pooled it
- Pooled it
- First-line treatments for BCG-naïve non-muscle invasive bladder cancer: a systematic review and meta-analysis.World journal of urology · 2026Pooled it
- Hyperthermia intravesical chemotherapy acts as a promising alternative to bacillus Calmette-Guérin instillation in non-muscle-invasive bladder cancer: a network meta-analysis.Frontiers in oncology · 2023Pooled it
- A 3-arm randomized control trial to compare the efficacy of re-circulant hyperthermic intravesical chemotherapy versus conventional intravesical mitomycin C and BCG therapy for intermediate-risk non-muscle invasive bladder cancer.World journal of urology · 2024Trial
- Diagnosis, evaluation, and management of patients with non-muscle invasive bladder cancer.Future science OA · 2026Review
- Overcoming barriers to bladder preservation: Emerging intravesical therapies for high-risk non-muscle-invasive bladder cancer.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2026Article
- Hyperthermic Intravesical Chemotherapy as a Bladder-Sparing Alternative to BCG in the Management of Non-Muscle-Invasive Bladder Cancer: A Systematic Review of Oncological Outcomes in the Era of BCG Shortage.Journal of clinical medicine · 2026Review
- Advances in the management of localized bladder cancers.Nature reviews. Clinical oncology · 2026Review
- Article
- Article
- Article
- Hyperthermic intravesical chemotherapy with gemcitabine versus Bacillus Calmette-Guerin in intermediate- and high-risk non-muscle-invasive bladder cancer.Frontiers in oncology · 2025Article
- Intravesical thermochemotherapy in the treatment of high-risk and very high-risk non-muscle-invasive urothelial bladder cancer: a single-arm study.International urology and nephrology · 2024Article
- Perfusion drugs for non‑muscle invasive bladder cancer (Review).Oncology letters · 2024Review
- Comparison of hyperthermic intravesical chemotherapy and Bacillus Calmette-Guerin therapy in high-risk non-muscle invasive bladder cancer: a matched-pair analysis.International urology and nephrology · 2024Article
- Device-Assisted Therapy in Non-Muscle-Invasive Bladder Cancer.Bladder cancer (Amsterdam, Netherlands) · 2024Review
- Adjuvant Hyperthermic Intravesical Chemotherapy in Intermediate- and High-Risk Non-muscle Invasive Bladder Cancer.Cureus · 2023Article
- Adjuvant intravesical treatment in patients with intermediate and high-risk non-muscle-invasive bladder cancer with BCG versus MMC applied with COMBAT or EMDA. Results of a prospective study.Journal of cancer research and clinical oncology · 2023Observational
- Hyperthermic intravesical chemotherapy with mitomycin-C for the treatment of high-risk non-muscle-invasive bladder cancer patients.BJUI compass · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe 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).
methodsA 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.
resultsFifty 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.
conclusionHIVEC provides comparable safety and efficacy to BCG and is a reasonable alternative during BCG shortages.
trial registrationEudraCT 2016-001186-85. Date of registration: 17 March 2016.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.