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Abstract：
BACKGROUND: Devices that increase the penetrance of intravesical chemotherapeutics are emerging as alternatives to classical Bacillus Calmette Guérin (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 20 mA 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.
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 20 mA 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.
摘要：
背景：增加膀胱内化疗剂渗透度的装置正在成为经典卡介苗（BCG）治疗的替代品。
目的：比较丝裂霉素C与电动给药装置（MMC-EMDA）和卡介苗在无原位癌（CIS）的中高危非肌层浸润性膀胱癌（NMIBC）患者中的疗效。
方法：前瞻性非随机研究，其中47例患者接受MMC-EMDA（40mgMMC在50mg蒸馏水中稀释，20mA，30分钟。每周6次，然后每月6次滴注），48例患者接受BCG（50mgOncoCITE®在50ml生理盐水中稀释60分钟。每周滴注6次，然后在第3、6和12个月滴注3次）。主要终点是24个月时的无复发率（RFR）。次要终点是24个月随访时的复发时间和无进展率（PFR）。
结果：两组患者的基线评估和平均随访时间相似（MMC-EMDA组：26.4个月；BCG组：28.4个月（p=0.44））。24个月时，MMC-EMDA组的RFR为80.9%，BCG组为77.1%(p=0.969)。MMC-EMDA组的平均复发时间为12.5个月，BCG组为14个月（p=0.681）。24个月时,MMC-EMDA组的PFR为97.9％，卡介苗组为93.8％（p=0.419）。
结论：在没有CIS的高危和中危NMIBC患者中，MMC-EMDA和BCG治疗没有差异。
目的：比较丝裂霉素C与电动给药装置（MMC-EMDA）和卡介苗在无原位癌（CIS）的中高危非肌层浸润性膀胱癌（NMIBC）患者中的疗效。
方法：前瞻性非随机研究，其中47例患者接受MMC-EMDA（40mgMMC在50mg蒸馏水中稀释，20mA，30分钟。每周6次，然后每月6次滴注），48例患者接受BCG（50mgOncoCITE®在50ml生理盐水中稀释60分钟。每周滴注6次，然后在第3、6和12个月滴注3次）。主要终点是24个月时的无复发率（RFR）。次要终点是24个月随访时的复发时间和无进展率（PFR）。
结果：两组患者的基线评估和平均随访时间相似（MMC-EMDA组：26.4个月；BCG组：28.4个月（p=0.44））。24个月时，MMC-EMDA组的RFR为80.9%，BCG组为77.1%(p=0.969)。MMC-EMDA组的平均复发时间为12.5个月，BCG组为14个月（p=0.681）。24个月时,MMC-EMDA组的PFR为97.9％，卡介苗组为93.8％（p=0.419）。
结论：在没有CIS的高危和中危NMIBC患者中，MMC-EMDA和BCG治疗没有差异。
