Urologic oncology · 2025
Single dose perioperative intravesical instillation of gemcitabine versus mitomycin-C following resection of non-muscle invasive bladder cancer: A randomized controlled trial.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Arulraj Kevin, Aggarwal Nitish, Nayak Brusabhanu, Nayyar Rishi, Kumar Rajeev, Seth Amlesh
Аннотация
PURPOSE: Immediate intravesical chemotherapy reduces recurrence in non-muscle invasive bladder cancer (NMIBC). Common agents currently used are mitomycin C (MMC) and gemcitabine. Gemcitabine was shown to reduce recurrence by 20% when compared to saline in the SWOG S0337 trial. There is no study that compares gemcitabine with MMC as an immediate intravesical agent in NMIBC.
METHODOLOGY: This was a phase II RCT involving patients suspected of NMIBC who underwent transurethral resection (TUR) in our center. Informed consent was obtained from all participants. We excluded patients with suspected bladder perforation, incomplete resection, urethral or ureteric disease, history of radiation, chronic kidney, or liver disease. Patients received either 2 g of gemcitabine or 40 mg of MMC within 6 hours after surgery. The primary outcomes were recurrence and progression at one year. The secondary outcomes were time to recurrence, time to progression, and adverse events.
RESULTS: A total of 44 patients in the gemcitabine arm and 48 patients in the MMC arm were considered for analysis. Baseline parameters, operative and histopathological characteristics were comparable between the 2 groups. At 1 year the recurrence rate was comparable between the 2 groups (12.6% vs. 18.7%; P = 0.96). One patient who received MMC had disease progression. The mean time to recurrence, cost of therapy, and incidence of adverse events were comparable between the 2 groups.
CONCLUSIONS: Immediate post-resection intravesical instillation of gemcitabine or MMC in patients with suspected NMIBC has comparable recurrence rates, time to recurrence, adverse effects, and cost. Longer follow-up and a larger patient cohort will strengthen our results.
METHODOLOGY: This was a phase II RCT involving patients suspected of NMIBC who underwent transurethral resection (TUR) in our center. Informed consent was obtained from all participants. We excluded patients with suspected bladder perforation, incomplete resection, urethral or ureteric disease, history of radiation, chronic kidney, or liver disease. Patients received either 2 g of gemcitabine or 40 mg of MMC within 6 hours after surgery. The primary outcomes were recurrence and progression at one year. The secondary outcomes were time to recurrence, time to progression, and adverse events.
RESULTS: A total of 44 patients in the gemcitabine arm and 48 patients in the MMC arm were considered for analysis. Baseline parameters, operative and histopathological characteristics were comparable between the 2 groups. At 1 year the recurrence rate was comparable between the 2 groups (12.6% vs. 18.7%; P = 0.96). One patient who received MMC had disease progression. The mean time to recurrence, cost of therapy, and incidence of adverse events were comparable between the 2 groups.
CONCLUSIONS: Immediate post-resection intravesical instillation of gemcitabine or MMC in patients with suspected NMIBC has comparable recurrence rates, time to recurrence, adverse effects, and cost. Longer follow-up and a larger patient cohort will strengthen our results.