May 2022

Promising results regarding the treatment of high-risk non-muscle-invasive bladder cancer (HR- NMIBC) patients with recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) as an alternative to intravesical bacillus Calmette–Guérin (BCG) were recently published in the World Journal of Urology. 

The clinical trial was designed and implemented by the Department of Urology at University Hospital 12 Octubre, Madrid, meeting the criteria for an investigator-initiated study.
The pilot phase II randomized clinical trial was conducted including HR-NMIBC patients, excluding carcinoma in situ (no CIS), following a two-arm study design with 50 enrolled patients (25 BCG – 25 HIVEC).

Summary:

• HIVEC has statistically superior Progression Free Survival (PFS) at 24 months (p<0.05)
• HIVEC has numerically superior Recurrence Free Survival (RFS) which is almost statistically significant (p=0.06)
• No difference in AEs (Tan et al - https://doi.org/10.1016/j.juro.2017.02.503)
• HIVEC was recognized as an excellent alternative during BCG shortages

Conclusion:

The study has proven that treatment with HIVEC administered through the Combat BRS System provides comparable safety and efficacy to treatment with BCG. Hence HIVEC® proves itself as a reasonable alternative to BCG, which is particularly relevant in the current health care environment, in which BCG has limited availability and alternative therapies are needed. 

Read more in World Journal of Urology:

Guerrero-Ramos, F., González-Padilla, D.A., González-Díaz, A. et al. 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. World J Urol 40, 999–1004 (2022). 
https://link.springer.com/article/10.1007/s00345-022-03928-1