*3.1.2 Adjuvant setting*

Arends et al. conducted a phase III open-label, randomized control trial among 190 intermediate and high-risk non-muscle-invasive bladder cancer patients. 1-yr hyperthermia with mitomycin C [20 mg/50 mL] for 2, 30-minute sessions for six weeks, and maintenance course three cycles] were administered. The primary endpoint was 24-month recurrence-free survival. The 24 months recurrence-free survival was 78.1% in the hyperthermia group and 64.8% in the BCG group [P = 0.08]. There was less than a 2% progression rate in both groups. No new adverse events were noted. In the per-protocol analysis, the 24 months recurrence-free survival was 81.8% in the hyperthermia group and 64.8% in the BCG group [P = 0.02]. The authors concluded that hyperthermia with Mitomycin C is safe and has a higher 2 year recurrence-free survival [21].
