Intravesical mitomycin-C (IMMC) is recommended immediately after transurethral resection of bladder tumor (TURBT) for non-muscle-invasive bladder cancer (NMIBC). However, a lack of compliance occurs due to the associated complications. Here, we aimed to assess the efficacy and safety of IMMC before TURBT in patients with NMIBC.
This was a single-center, open-label, parallel-arm, randomized phase II clinical trial in patients with suspected NMIBC before TURBT. Participants were randomly assigned (1:1) to receive 2 doses of IMMC (40 mg/20 mL) 1 day and 4 h before TURBT (n = 49) or no treatment (n = 50) with block randomization (size 2 and 4), stratified by Bacillus Calmette-Guérin/IMMC. The primary endpoint was recurrence-free survival and secondary endpoints were progression-free survival and adverse events (AEs) in the per-protocol analysis.
Seventy-one patients (33, intervention; 38, control) were well matched for baseline characteristics. Sixty-one had been followed without recurrence for at least 10.4 months; 3 and 8 patients showed recurrence in the intervention and control groups, respectively. The 1-year recurrence-free survival rate was 97% and 89% for the intervention and control groups, respectively. Neoadjuvant IMMC resulted in a reduction (63%) in the relative recurrence risk (hazard ratio, 0.37; 80% 1-sided confidence interval, -∞-0.65, P = 0.11). Disease progression occurred in 3 patients in the control group (P = 0.051) but not in the intervention group. Neoadjuvant IMMC was well tolerated, and AEs were local and of grade 1/2.
Two doses of neoadjuvant IMMC are safe and effective in reducing NMIBC recurrence and progression after TURBT.
The Journal of urology. 2022 Oct 12 [Epub ahead of print]
Hye Won Lee, Hyung Ho Lee, Eun Young Park, Weon Seo Park, Sung Han Kim, Jae Young Joung, Jinsoo Chung, Ho Kyung Seo
Department of Urology, Center for Urologic Cancer, National Cancer Center, Goyang, Korea., Biostatistics Collaboration Team, Research Core Center, National Cancer Center, Goyang, Korea., Department of Pathology, Center for Urologic Cancer, National Cancer Center, Goyang, Korea.