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Abstract：
BACKGROUND: High grade, non-muscle invasive bladder cancer (NMIBC) is usually treated with intravesical Bacillus Calmette-Guérin. Chemohyperthermia therapy (CHT) may be a novel alternative therapy for the treatment of NMIBC.
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.
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.
摘要：
背景：高品位，非肌肉浸润性膀胱癌（NMIBC）通常用膀胱内芽孢杆菌卡介苗治疗。化学热疗（CHT）可能是治疗NMIBC的一种新型替代疗法。
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。
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。
