The efficacy of hyperthermic intravesical chemotherapy in high-risk non-muscle-invasive bladder cancer patients with BCG intolerance.

Background And Aim: Some patients with high-risk non-muscle-invasive bladder cancer (NMIBC) are unable to receive adequate BCG instillations due to intolerance. In this study we aimed to investigate the efficacy and tolerability of hyperthermic intravesical chemotherapy (HIVEC®) treatment using Mitomycin C (MMC) in BCG-intolerant NMIBC patients.

Methods: Retrospectively collected data from a total of 22 high-risk papillary NMIBC patients who received adjuvant HIVEC therapy for BCG intolerance were analyzed. The primary outcomes of the study were recurrence-free survival (RFS), time to recurrence, progression-free survival (PFS), and time to progression following initial TURB. Detection of histologically confirmed urothelial carcinoma during follow-up was considered as recurrence, while detection of muscle-invasive disease was defined as progression. The secondary outcome was adverse events of HIVEC treatment.

Results: The median follow-up was 32.2 (IQR: 17.8-42.8) months. The RFS and PFS rates were 81.8% and 95.4%, respectively. The mean time to tumor recurrence and progression was 29.2 ± 14.3 and 16.7 months, respectively. Adverse events occurred in 50% of patients, and 95% of adverse events were mild to moderate.

Conclusion: This study demonstrated that adjuvant HIVEC with MMC is an effective and safe alternative bladder sparing treatment in BCG intolerant high risk papillary NMIBC patients.