OBJECTIVE: To evaluate the recurrence-free survival (RFS) of patients treated with CHT using the Combat bladder recirculation system (BRS) for NMIBC.
METHODS: This was a prospective multi-institutional study of 1,028 consecutive patients with NMIBC undergoing CHT between 2012 and 2020. A total of 835 patients were treated with CHT with Mitomycin C (MMC). Disease was confirmed on transurethral resection of bladder tumor (TURBT) prior to starting CHT. Follow-up included cystoscopy and subsequent TURBT if recurrence/progression was suspected. The primary endpoint was RFS. Secondary endpoints were progression-free survival (PFS) and adverse events from CHT.
CONCLUSIONS: Median follow up was 22.4 months (Interquartile range (IQR): 12.8 -35.8). Median age was 70.4 years (IQR: 62.1 -78.6). A total of 557 (66.7%), 172 (20.6) and 74 (8.9%) of patients were classified to BCG naïve, BCG unresponsive and BCG failure, respectively. The RFS at 12 months and 24 months for BCG naïve was 87.6% (95% CI 85.0% - 90.4%) and 75.0% (95% CI 71.3% - 78.8%), respectively. The RFS at 12 months and 24 months for BCG unresponsive cohort was 78.1% (95% CI 72.0% - 84.7%) and 57.4% (95% CI 49.7% - 66.3%), respectively. The RFS at 24 months for the BCG unresponsive cohort for CIS with/without papillary disease and papillary only disease were 43.6% (95% CI 31.4% -60.4%) and 64.5% (95% CI 55.4% - 75.1%), respectively. Minor adverse events occurred in 216 (25.6%) patients and severe events occurred in 17 (2.0%) patients.
CONCLUSIONS: CHT with MMC using the Combat BRS is effective in the medium term and has a favorable adverse event profile.
目的:评估使用战斗膀胱再循环系统(BRS)治疗NMIBC的CHT患者的无复发生存率(RFS)。
方法:这是一项前瞻性多机构研究,对2012年至2020年间接受CHT的1,028例NMIBC连续患者进行。共有835例患者接受了CHT和丝裂霉素C(MMC)治疗。在开始CHT之前,经尿道膀胱肿瘤切除术(TURBT)证实了疾病。如果怀疑复发/进展,随访包括膀胱镜检查和随后的TURBT。主要终点是RFS。次要终点是无进展生存期(PFS)和CHT的不良事件。
结论:中位随访时间为22.4个月(四分位距(IQR):12.8-35.8)。中位年龄为70.4岁(IQR:62.1-78.6)。共有557人(66.7%),172(20.6)和74(8.9%)的患者被归类为卡介苗,BCG无反应和BCG故障,分别。卡介苗初始治疗12个月和24个月时的RFS分别为87.6%(95%CI85.0%-90.4%)和75.0%(95%CI71.3%-78.8%),分别。BCG无反应队列在12个月和24个月时的RFS分别为78.1%(95%CI72.0%-84.7%)和57.4%(95%CI49.7%-66.3%),分别。对于有/无乳头状疾病和仅有乳头状疾病的CIS,BCG无反应队列在24个月时的RFS分别为43.6%(95%CI31.4%-60.4%)和64.5%(95%CI55.4%-75.1%),分别。216例(25.6%)患者发生轻微不良事件,17例(2.0%)患者发生严重事件。
结论:CHT联合MMC使用CombatBRS在中期内有效,并且具有良好的不良事件特征。