Over 614,000 patients are diagnosed with bladder cancer every year, and around 70-85% of those have non-muscle-invasive bladder cancer (NMIBC).
Current treatment comprises complete resection of visible tumour, with adjuvant BCG intravesical installation recommended to reduce the risk of recurrence and progression in patients with high-risk NMIBC. However, tumours recur in at least 40-50% of these patients, with 10-20% progressing to muscle-invasive or metastatic bladder cancer.
The standard of care for BCG-unresponsive patients is radical cystectomy, involving removal of the bladder together with nearby lymph nodes, and often part of the bowel, the prostate gland and seminal vesicles in males, and the womb and fallopian tubes in females. It is curative in 80-90% if performed prior to progression to muscle-invasive bladder cancer.
However, radical cystectomy may not be a suitable treatment alternative as it is associated with a higher degree of morbidity and mortality, while some patients refuse it on quality-of-life grounds.
Combat Medical has entered into partnership with the University of Leicester to run a phase 3 trial of its HIVEC® treatment for BCG-unresponsive nonmuscle-invasive bladder cancer (NMIBC) as an alternative to radical cystectomy.
HIVEC®’s use as a safe and well-tolerated bladder-sparing alternative to radical cystectomy in BCG-unresponsive high-risk NMIBC has already been demonstrated in a series of smaller prospective and retrospective studies.
HIVEC®-HEAT – HIVEC® (Hyperthermic intravesical mitomycin mEdac) for pAtients with BCG-unresponsive nonmuscle-invasive bladder cancer Trial – is a multi-centre, single-arm interventional trial across 25 NHS hospitals in the UK.
We’re confident this phase 3 trial will prove that HIVEC® is a game-changer in the treatment of high-risk, BCG-unresponsive patients, especially at a time of acute BCG shortages worldwide.
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