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GU Cancers 2023 | The rationale behind the Phase III trial on neoadjuvant intravesical MMC treatment of bladder cancer

Massimo Lazzeri, MD, PhD, IRCCS Humanitas Research Hospital, Milan, Italy, shares the rationale for the randomized Phase III clinical trial of neoadjuvant intravesical mitomycin C (MMC) treatment in patients with primary treatment-naïve non-muscle invasive bladder cancer (NMIBC). The current standard-of-care for NMIBC is transurethral resection (TUR) followed by adjuvant intravesical therapies with immunotherapy (BCG) and/or chemotherapy agents such as mitomycin C (MMC). However, response to MMC is variable and there remains an unmet need to improve efficacy to reduce the rate of recurrence and progression to muscle invasive BC (MIBC). Recent studies were shown to induce immunogenic cell death which has been associated with specific damage signals, like HMGB1 molecule. The identification of immunogenic cell death as an immune-related mechanism of action of MMC may provide opportunities to optimize the treatment of bladder cancer if used in the neoadjuvant setting. Thus, the current Phase III trial is aiming to assess whether the neoadjuvant treatment of NMIBC with MMC can reduce the recurrence rate and progression to MIBC. The primary endpoint was to evaluate the efficacy of MMC neoadjuvant treatment in reducing the recurrence rate calculated as the proportion of patients who achieve a complete response. The secondary clinical endpoint was the analysis of the rate of grade and stage progression to MIBC in case of recurrence and the correlation with specific biomarker. This interview took place at the ASCO GU Cancers Symposium 2023 in San Francisco, CA.

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