Check out this short video showing how to safely and easily mix 80mg of mitomycin C into 40ml of fluid and administer it via the Combat BRS (Bladder Recirculation) HIVEC® kit for treating non-muscle-invasive bladder cancer:
This is the dose being used in the HIVEC®-HEAT trial, and it’s shown excellent results in a pilot study from Dr Kastner, Professor Heidenreich and the team at University Hospital Cologne:
Kastner et al. “HIVEC as an alternative option in non-muscle-invasive bladder cancer: experiences from a high-volume center.” Urologic Oncology Seminars and Original Investigations, 2024:
https://www.sciencedirect.com/science/article/pii/S1078143924003405
HIVEC HEAT and Non-Muscle-Invasive Bladder Cancer
Non-muscle-invasive bladder cancer (NMIBC) is one of the most challenging urological cancers to treat. It is not immediately life-threatening; however, it has a high recurrence rate and requires repeated interventions. While intravesical chemotherapy has long been a mainstay of treatment, Combat’s hyperthermic intravesical chemotherapy (HIVEC®) is being recognised as a promising new alternative.
The use of mitomycin C administered via the Combat BRS HIVEC® kit is currently being evaluated in the HIVEC®-HEAT trial. A recently published pilot study by Dr. Kastner, Professor Heidenreich, and colleagues at the University Hospital Cologne highlights the safety, efficacy, and practicality of this treatment in cancer patients.
Mitomycin C in NMIBC: A Brief Background
Mitomycin C (MMC) has been widely used for decades as an intravesical chemotherapy agent for NMIBC. Its mechanism of action involves DNA crosslinking, which inhibits cancer cell proliferation and induces apoptosis. Despite its effectiveness, traditional administration methods face limitations:
- Rapid washout of the drug from the bladder reduces efficacy.
- Variable drug penetration into the urothelium.
- Local toxicity leading to chemical cystitis in some patients.
Device-assisted HIVEC® therapy was developed to overcome these challenges.
What is HIVEC® and Why Use the Combat BRS System?
Hyperthermic Intravesical Chemotherapy (HIVEC®) combines two synergistic strategies:
- Chemotherapy with mitomycin C
- Localised bladder hyperthermia (42–43°C)
Hyperthermia increases urothelial permeability and potentiates the cytotoxic effect of MMC, thereby enhancing drug penetration and improving outcomes for cancer patients.
The Combat BRS HIVEC® kit is a closed-circuit recirculation system designed for safe and effective delivery. It maintains constant drug temperature, ensures even distribution across the bladder wall, and minimises healthcare workers’ exposure to cytotoxic agents.
Mixing and Preparing Mitomycin C for HIVEC®
A vital part of this therapy is the correct preparation of mitomycin C, as shown in the video. The preparation being demonstrated reflects the dosing strategy used in the HIVEC®-HEAT trial, designed to maximise therapeutic benefit while minimising toxicity. The video shows how the drug can be safely reconstituted and loaded into the device in a controlled, user-friendly manner – which is an important consideration for adoption in busy urology departments.
Administration via Combat BRS
Once prepared, the drug is introduced into the bladder through the Combat BRS system, which operates in a closed-loop recirculation circuit. Key advantages include:
- Consistent Drug Temperature: The system maintains MMC at therapeutic hyperthermic levels.
- Even Drug Distribution: Continuous circulation ensures all bladder surfaces are exposed.
- Reduced Risk to Staff: The closed system prevents drug spillage or vaporisation.
- Patient Comfort: Compared with older methods, the procedure is streamlined and less invasive.
Typically, each treatment cycle lasts about 60 minutes, after which the drug is safely evacuated.
Clinical Evidence Supporting HIVEC® with MMC
The HIVEC®-HEAT trial (ISRCTN49174478) is currently investigating this therapeutic approach in a controlled, multicentre setting. Early-phase data are highly encouraging.
The pilot study by Kastner et al. (2024), conducted at University Hospital Cologne, demonstrated:
- Excellent feasibility in a high-volume clinical setting.
- Promising oncologic outcomes, with reduced recurrence rates compared to standard MMC.
- Tolerability, with manageable side effects and no unexpected safety concerns.
These findings suggest that HIVEC® with MMC may become a great alternative for patients with intermediate- and high-risk NMIBC, especially those who are unfit for or resistant to BCG therapy.
The Benefits of HIVEC® for both Urologists and Patients
The use of HIVEC® for the treatment of NMIBC comes with several potential advantages:
- Greater efficacy compared with traditional MMC instillations.
- Improved patient compliance, thanks to tolerability and shorter treatment schedules.
- A practical alternative to BCG.
- Straightforward adoption, with clear preparation protocols and device support.
As we gather more evidence from the ongoing HIVEC®-HEAT trial, we are hopeful that HIVEC will become a mainstream therapeutic option for NMIBC in the near future. Watch this space for updates…
