[Safety of Hyperthermic IntraVEsical Chemotherapy (HIVEC) for BCG Unresponsive Non-Muscle Invasive Bladder Cancer...

Area of Science:

• Urology
• Oncology
• Medical Devices

Background:

• Non-muscle invasive bladder cancer (NMIBC) shows increasing evidence of effective treatment with Hyperthermic Intravesical Chemotherapy.
• The COMBAT BRS system (HIVEC) is an innovative device for hyperthermia delivery.
• This study evaluates the tolerance and safety of HIVEC in patients with BCG-refractory NMIBC.

Purpose of the Study:

• To assess the safety and tolerance of Hyperthermic Mitomycin Intravesical Chemotherapy (HIVEC) in patients with BCG-refractory non-muscle invasive bladder cancer (NMIBC).

Main Methods:

• A total of 22 patients with BCG-refractory NMIBC were enrolled between January 2017 and April 2018.
• Patients received weekly instillations of Hyperthermic Mitomycin for 6 weeks, with follow-up assessments.
• Tolerance was evaluated using questionnaires, and safety and efficacy were analyzed after one year.

Main Results:

• No severe side effects were reported; common minor side effects included urinary urgency and pain (40.1%), and hematuria (4.5%).
• The International Prostate Symptom Score (IPSS) did not significantly change.
• The recurrence rate was 27.3% within the first year, with two patients progressing to muscle-invasive disease.

Conclusions:

• Hyperthermic Mitomycin delivered via the HIVEC device appears to be a safe and well-tolerated treatment option for BCG-refractory NMIBC.
• The treatment demonstrated partial efficacy, with a notable recurrence rate in the first year.
• Prospective multicentric studies are recommended to validate these findings.