Onishi Takehisa, Sekito Sho, Shibahara Takuji, Uchida Katsunori, Sasaki Takeshi
a Department of Urology , Ise Red Cross hospital , Ise , Japan.
b Department of Pathology , Ise Red Cross hospital , Ise , Japan.
Scand J Urol. 2018 Oct-Dec;52(5-6):385-388. doi: 10.1080/21681805.2018.1548502. Epub 2019 Jan 10.
To compare the efficacy and safety of continuous saline bladder irrigation (CSBI) to a single immediate instillation of chemotherapy after transurethral resection of bladder tumor (TURBT) in patients with high grade primary non-muscle invasive bladder cancer (HG-NMIBC).
This study retrospectively reviewed 250 patients with primary NMIBC who were enrolled in a prospective randomized trial of CSBI vs single instillation of mitomycin C (SI-MMC) immediately after TURBT. Results of histopathology were re-reviewed using the World Health Organization (WHO) 2004/2016 classification. Of the 250 patients, 151 HG-NMIBC patients (78 in the CSBI group and 73 in the SI-MMC group) were evaluated according to the recurrence and progression rates and adverse events.
The median follow-up period was 58 months. No significant differences for patients' characteristics were observed between the CSBI group and SI-MMC group. There was no statistically significant difference between the CSBI group and SI-MMC. group regarding recurrence rates of 12, 18 and 24 months (25.6% vs 23.3%、28.5% vs 23.3% and 32.1% vs 28.8%, respectively), time to first recurrence (12.6 ± 11 vs 12.4 ± 10.1 months) and progression rate (8.9% vs 8.2%). The incidence of adverse events was significantly lower in the C.S.B.I. group.
The difference of recurrence and progression rate between CSBI and SI-MMC after TURBT was not statistically significant in HG-NMIBC, although a larger study is necessary to prove its equivalence or non-inferiority. CSBI after TURBT is easy to administer with a reduced risk of adverse events, and may be a treatment choice for patients with HG-NMIBC.
比较连续膀胱灌注生理盐水（CSBI）与经尿道膀胱肿瘤电切术（TURBT）后单次即刻灌注化疗在高级别原发性非肌层浸润性膀胱癌（HG-NMIBC）患者中的疗效和安全性。
本研究回顾性分析了250例原发性NMIBC患者，这些患者参加了一项前瞻性随机试验，比较TURBT后CSBI与单次灌注丝裂霉素C（SI-MMC）的效果。使用世界卫生组织（WHO）2004/2016分类法对组织病理学结果进行重新评估。在这250例患者中，根据复发率、进展率和不良事件对151例HG-NMIBC患者（CSBI组78例，SI-MMC组73例）进行了评估。
中位随访期为58个月。CSBI组和SI-MMC组患者的特征无显著差异。CSBI组和SI-MMC组在12、18和24个月的复发率（分别为25.6%对23.3%、28.5%对23.3%和32.1%对28.8%）、首次复发时间（12.6±11对12.4±10.1个月）和进展率（8.9%对8.2%）方面无统计学显著差异。CSBI组不良事件的发生率显著更低。
在HG-NMIBC中，TURBT后CSBI和SI-MMC之间的复发率和进展率差异无统计学意义，尽管需要更大规模的研究来证明其等效性或非劣效性。TURBT后CSBI易于实施，不良事件风险降低，可能是HG-NMIBC患者的一种治疗选择。
