Longoni Mattia, Scilipoti Pietro, De Angelis Mario, Zaurito Paolo, Tremolada Giovanni, Santangelo Alfonso, Simone Giuseppe, Mastroianni Riccardo, Lonati Chiara, Zamboni Stefania, Suardi Nazareno, Marcq Gautier, Szostek Aleksandra, Caño Velasco Jorge, Puentedura Alfonso Lafuente, Subiela José Daniel, Durán Pedro Del Olmo, Ślusarczyk Aleksander, Karakiewicz Pierre I, Pradere Benjamin, Soria Francesco, Gontero Paolo, Rouprêt Morgan, Montorsi Francesco, Salonia Andrea, Briganti Alberto, Moschini Marco
Department of Experimental Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy.
Vita-Salute San Raffaele University, Milan, Italy.
BJU Int. 2025 Nov;136(5):826-834. doi: 10.1111/bju.16780. Epub 2025 May 21.
To report real-world rates of non-muscle-invasive bladder cancer (NMIBC) recurrence and progression within a European multicentre cohort with detailed information on intravesical instillation courses, as contemporary data on oncological outcomes in NMIBC are limited.
A total of 1918 patients with NMIBC treated with transurethral resection of bladder tumour (TURBT) were retrospectively identified from six tertiary-referral European centres (2015-2022). Patients were stratified according to European Association of Urology 2021 criteria into low- (LR), intermediate- (IR), high- (HR) and very high-risk (VHR) categories. Cumulative incidence plots and multivariable competing risks regression models addressing 5-year rates of high-grade (HG) recurrence and progression were fitted. Sensitivity analyses focused on patients receiving intravesical instillations and tested for the effect of adequate course (Bacillus Calmette-Guérin: five or more induction + two or more maintenance instillations; mitomycin C: complete induction + ≥11 maintenance instillations).
Of all NMIBC patients identified, 467 (24.3%) were LR vs 582 (30.3%) IR vs 739 (38.5%) HR vs 130 (6.8%) VHR. The median (interquartile range) follow-up after TURBT was 26 (12-46) months. The 5-year HG recurrence rates were 7.2% in LR vs 17.3% in IR vs 26.7% in HR vs 30.9% in VHR patients, resulting in a three-, five- and seven-fold higher risk of IR, HR and VHR, respectively, relative to LR (all P < 0.001). The 5-year progression rates were 3.9% in LR vs 5.2% in IR vs 13.6% in HR vs 31.6% in VHR patients, resulting in a six- and nine-fold higher risk for HR and VHR, respectively, relative to LR (all P < 0.001). In all, 1001 (52.2%) patients underwent intravesical instillations. Those receiving adequate instillation course (244/1001 [24.3%]) had lower HG-recurrence (hazard ratio 0.3, P < 0.001) and progression (hazard ratio 0.2, P = 0.001) risk.
Patients with HR/VHR NMIBC face significantly higher HG recurrence and progression risks. While tailored treatment strategies are needed, adherence to adequate instillation course remains crucial for optimising oncological outcomes.
报告欧洲多中心队列中非肌层浸润性膀胱癌（NMIBC）的真实复发率和进展率，并提供膀胱内灌注疗程的详细信息，因为目前关于NMIBC肿瘤学结局的当代数据有限。
从欧洲六个三级转诊中心（2015 - 2022年）回顾性确定了1918例接受经尿道膀胱肿瘤切除术（TURBT）治疗的NMIBC患者。根据欧洲泌尿外科学会2021年标准，将患者分为低风险（LR）、中风险（IR）、高风险（HR）和极高风险（VHR）类别。绘制了累积发病率图，并拟合了多变量竞争风险回归模型，以分析5年高级别（HG）复发率和进展率。敏感性分析聚焦于接受膀胱内灌注的患者，并测试了足够疗程（卡介苗：5次或更多诱导 + 2次或更多维持灌注；丝裂霉素C：完整诱导 + ≥11次维持灌注）的效果。
在所有确定的NMIBC患者中，467例（24.3%）为LR，582例（30.3%）为IR，739例（38.5%）为HR，130例（6.8%）为VHR。TURBT后的中位（四分位间距）随访时间为26（12 - 46）个月。LR患者的5年HG复发率为7.2%，IR患者为17.3%，HR患者为26.7%，VHR患者为30.9%，相对于LR患者，IR、HR和VHR患者的风险分别高出2倍、4倍和6倍（所有P < 0.001）。LR患者的5年进展率为3.9%，IR患者为5.2%，HR患者为13.6%，VHR患者为31.6%，相对于LR患者，HR和VHR患者的风险分别高出5倍和8倍（所有P < 0.001）。共有1001例（52.2%）患者接受了膀胱内灌注。接受足够灌注疗程的患者（244/1001 [24.3%]）的HG复发风险较低（风险比0.3，P < 0.001），进展风险也较低（风险比0.2，P = 0.001）。
HR/VHR NMIBC患者面临显著更高的HG复发和进展风险。虽然需要量身定制治疗策略，但坚持足够的灌注疗程对于优化肿瘤学结局仍然至关重要。
