Shariat - Figure 53
Phase 3 Randomized Controlled Trial of Chemohyperthermia vs BCG in Intermediate- and High-risk NMIBC
FIG. 53: Other treatments, including salvage intravesical therapies but also alternatives to BCG, are in development. One alternative to BCG in patients with intermediate- and high-risk NMI bladder cancer, specifically in T1 high-grade cancer, is chemohyperthermia. A device, the Synergo® system, delivers mitomycin via an intravesicular system based on thermocouples that emit radiofrequency energy to generate heat at the target tissue. This Figure highlights data from a randomized Phase 3 controlled trial in 190 patients who were randomized to 1 year of chemohyperthermia delivered via the Synergo® system as 6 weekly doses followed by 6 months of maintenance or 1 year of BCG, 6 weekly doses and 9 maintenance doses.[70] The results were compelling, with the 24-month recurrence-free survival statistically significantly lower in the chemohyperthermia group vs the BCG group (per protocol analysis, 81.8% vs 64.8%, P=0.02).
References
Arends TJ, Nativ O, Maffezzini M, et al. Results of a randomised controlled trial comparing intravesical chemohyperthermia with mitomycin C versus bacillus Calmette-Guérin for adjuvant treatment of patients with intermediate- and high-risk non-muscle-invasive bladder cancer. Eur Urol. 2016;69:1046-52 http://dx.doi.org/10.1016/j.eururo.2016.01.006
