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EAU 2021 | Preliminary safety results of the MITOBCG study in NMIBC

Cosimo De Nunzio, MD, PhD, Sapienza University of Rome, Rome, Italy, shares an update on the preliminary findings of the Phase IV MITOBCG study (NCT03790384), which is investigating the safety and efficacy of sequential mitomycin and Bacillus Calmette-Guérin (BCG) versus BCG therapy alone for patients with high-risk non muscle-invasive bladder cancer (NMIBC). Dr De Nunzio talks on the initial safety findings, reporting that of 20 patients enrolled in the combination therapy arm so far, no significant differences in adverse effects have been observed in comparison to the BCG monotherapy arm, with three patients experiencing high-grade adverse events in each arm. This interview took place at the virtual European Association of Urology (EAU) Virtual Meeting 2021.

Transcript (edited for clarity)

So, this study is a prospective randomized study, including patients with high-grade bladder tumor, in particular T1, G3, or carcinoma in situ. And we randomized these patients in two groups. One group is a BCG installation, where six weekly installation is a standard course. And the other group, they receive one daily – there is two different installation – one day for mitomycin, then the day after from of BCG...

So, this study is a prospective randomized study, including patients with high-grade bladder tumor, in particular T1, G3, or carcinoma in situ. And we randomized these patients in two groups. One group is a BCG installation, where six weekly installation is a standard course. And the other group, they receive one daily – there is two different installation – one day for mitomycin, then the day after from of BCG.

So, the study is still ongoing. And here during this congress, we present our preliminary results, particularly focused on the safety of this new possibility. And in the first 20 patients enrolled in the combination treatment we observed no significant and no particular adverse events when compared to the standard group. The rate of adverse events evaluated using the Clavien classification system is very low, and only three patients in both groups experienced a high-grade complication, including a urethral stenosis, or a urinary tract infection, but they are expected and they’re not new.

So, we hope that together with safety next year we are able to present the results on efficacy. And because this a new combination, it could be another option to manage patients with high-grade bladder cancer.

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