Electromotive Drug Administration Chemotherapy with Mitomycin C Versus Bacillus Calmette-Guerin for the Treatment of Non-Muscle Invasive Bladder Cancer
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IOS Press BV
Materia
Bladder cancer Hyperthermia Induced Bacillus calmette-guerin Administration Intravesical Mitomycin C
Date
2023-06-27Referencia bibliográfica
M.T. Melgarejo-Segura et al. / EMDA vs BCG as Treatment of NMIBC[DOI 10.3233/BLC-230042]
Abstract
BACKGROUND: Devices that increase the penetrance of intravesical chemotherapeutics are emerging as alternatives to
classical Bacillus Calmette Gu´erin (BCG) treatment.
OBJECTIVE: To compare the efficacy of mitomycin C applied with the electromotive drug delivery device (MMC-EMDA)
versus BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) without carcinoma in
situ (CIS).
METHODS: Prospective non-randomized study in which 47 patients received MMC-EMDA (40 mg of MMC diluted in
50 mg of distilled water at 20mA for 30 min. Regimen of 6 weekly and then 6 monthly instillations) and 48 patients received
BCG (50 mg of OncoCITE® diluted in 50 ml of normal saline for 60 min. Regimen of 6 weekly instillations and then
3 weekly instillations at months 3, 6 and 12). The primary endpoint was the recurrence-free rate (RFR) at 24 months.
Secondary endpoints were time to recurrence and progression-free rate (PFR) at 24 months follow-up.
RESULTS: Baseline patient assessment and mean follow-up time were similar in both groups (MMC-EMDA group: 26.4
months; BCG group: 28.4 months (p = 0.44)). The RFR at 24 months was 80.9% for the MMC-EMDA group and 77.1% for
the BCG group (p = 0.969). The mean time to recurrence was 12.5 months in the MMC-EMDA group and 14 months in the
BCG group (p = 0.681). At 24 months, PFR was 97.9% in the MMC-EMDA group and 93.8% in the BCG group (p = 0.419).
CONCLUSIONS: No differences were found between MMC-EMDA and BCG treatments in patients with high-risk and
intermediate-risk NMIBC without CIS.