[EMDA with MMC. Critical review]

Abstract

Two Phase II studies, three Phase III and one observational study seem to justify that EMDA-MMC is a real alternative in the treatment of patients with NMIBC, especially the high risk group. The phase III studies compare EMDA-MMC with passive diffusion MMC and BCG in patients with bladder TIS. They showed EMDA MMC superiority compared to passive diffusion MMC and similar to BCG in achieving complete response at 3 and 6 months. In another randomized study on pT1 NMIBC patients, comparing a sequential scheme of BCG plus EMDA-MMC and BCG, the sequential regimen was significantly superior than BCG reducing recurrence and progression and improved overall and specific survivals. A third randomized study compared TURBT only with immediate post TURBT MMC instillation and EMDA-MMC preoperative instillation. This latter showed to be superior in recurrence prevention than the other two schemes. Tolerance to EMDA-MMC is inferior to passive diffusion MMC, but it does not reach statistical significance. In the same way, EMDA-MMC tolerance is better than BCG and there is no difference between this and the sequential scheme of BCG plus EMDA-MMC. Methodological defects observed in these studies and the fact that almost all of them come from the same group makes it necessary to reproduce this data in other centers so that this therapeutic alternative could be included in guidelines.