Ways to increase the effectiveness of intravesical chemotherapy with Mitomycin-C in patients with high-risk of non-muscle-invasive bladder cancer.

The objective: to analyze the experience of using hyperthermic intravesical chemotherapy (HIVEC) with Mitomycin-C (MMC) and the addition of dimethyl sulfoxide (DMSO) in high-risk of non-muscle-invasive bladder cancer (HR NMIBC) patients and to compare oncological results with BCG therapy. Materials and methods. From March 2018 to January 2021, 53 patients with high-risk of NMIBC underwent a HIVEC adjuvant regimen at the University Clinic of Odessa National Medical University. The results were compared with a group of patients who received adjuvant intravesical BCG therapy from 2015 to 2019. In the HIVEC group, 16 (30.2%) patients with reduced bladder capacity underwent a session of the HIVEC therapy with prior injection of DMSO solution into the bladder. The primary endpoint was recurrence-free survival (RFS). Secondary endpoints were time to recurrence, progression-free survival (PFS), cancer-specific survival and overall survival at 36 months. Results. The incidence of the disease recurrence (42.6% vs 22.6%; p=0.028) and progression (20.4% vs 7.5%; p=0.50) were different between the BCG and HIVEC, respectively. The mean time to recurrence in patients who received HIVEC MMC was significantly higher than in patients of the BCG group: 31.5 months (95% CI: 29.1-34.0) versus 26.0 months (95% CI: 22.7-29.3), respectively (p=0.034). Cox regression analysis showed that the hazard ratio for HIVEC vs BCG for the RFS at 36 months was 0.48 (95% CI: 0.24-0.96; p=0.04). The RFS and the PFS indicators during the 36-month follow-up period in patients who received additional intravesical DMSO administration were not significantly different from other patients in the HIVEC therapy group. Conclusions. Hyperthermic intravesical chemotherapy with the addition of DMSO is a safe treatment option for patients with high-risk of noninvasive bladder cancer with efficacy comparable to BCG therapy. [ABSTRACT FROM AUTHOR]