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JU INSIGHT: Neoadjuvant Intravesical Mitomycin-C Before Transurethral Resection of Bladder Tumor

By: Hye Won Lee, MD, PhD; Hyung Ho Lee, MD, PhD; Eun Young Park, MS; Weon Seo Park, MD, PhD; Sung Han Kim, MD, PhD; Jae Young Joung, MD, PhD; Jinsoo Chung, MD, PhD; Ho Kyung Seo, MD, PhD | Posted on: 17 Jan 2023

Lee HW, Lee HH, Park EY, et al. Neoadjuvant intravesical mitomycin-C before transurethral resection of bladder tumor. J Urol. 2023;209(1):131-139.

Figure. Kaplan-Meier curve for recurrence-free survival of all the patients treated with neoadjuvant mitomycin-C intravesical instillation or transurethral resection of bladder tumor (TURBT) alone.

Study Need and Importance

A single dose of intravesical mitomycin-C instillation (IMMC) immediately after transurethral resection of bladder tumors (TURBTs) is a cornerstone in the earliest prophylaxis of tumor recurrence in nonmuscle-invasive bladder cancer. However, mitomycin-C is a representative vesicant agent; hence, there is a compliance failure worldwide, particularly in the situations of a deep resection, or suspected bladder perforation during TURBT due to serious complications related to extra-vesical leakage. We evaluated a short-schedule neoadjuvant IMMC to expect anti-tumor effects from the start of TURBT with minimal toxicity, which can be applied to potentially all patients regardless of the extension and depth of the TURBT.

What We Found

In this single-center, randomized phase II trial, 2 pre-TURBT IMMCs were performed on 1 day and 4 hours before TURBT (the intervention group) or not (the control group). In the per-protocol analysis, 71 patients (33, intervention; 38, control) were well balanced for baseline characteristics. The duration of enrollment was 52.4 months, and 3 and 8 patients showed recurrence in the intervention and control groups, respectively. Neoadjuvant IMMC resulted in a 63% reduction in the relative recurrence risk (see Figure). Disease progression did not occur in the intervention group, but it occurred in 3 patients in the control group. Notably, only 5 patients experienced IMMC-related adverse events, which were local and classified as either grade 1 or 2.

Limitations

The main weaknesses of this trial are a single-center study with a small cohort, the rates of tumor recurrence/progression events lower than expected, and the design without a group treated with a single, immediate early IMMC after TURBT.

Interpretation for Patient Care

Neoadjuvant IMMC is well tolerated and beneficial in reducing nonmuscle-invasive bladder cancer recurrence and progression after TURBT. Future phase III, multicenter trials are warranted to introduce this regimen in routine clinical practice.

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