Zaurito Paolo, Scilipoti Pietro, Longoni Mattia, de Angelis Mario, Re Chiara, Quarta Leonardo, Tremolada Giovanni, Burgio Giusy, Pellegrino Francesco, Rosiello Giuseppe, Necchi Andrea, Colombo Renzo, Gandaglia Giorgio, Salonia Andrea, Montorsi Francesco, Briganti Alberto, Moschini Marco
Division of Experimental Oncology, Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Via Olgettina, 60, 20132, Milan, Italy.
Vita-Salute San Raffaele University, Milan, Italy.
World J Urol. 2024 Dec 30;43(1):52. doi: 10.1007/s00345-024-05417-z.
The intermediate-risk non-muscle invasive bladder cancer (IR-NMIBC) prognostic group is heterogeneous. Growing evidence supports the role of active surveillance (AS) for patients with low-risk NMIBC, however, no clear data exists considering IR-NMIBC. The aim of the study was to assess the risk of recurrence of patients eligible for AS based on the International Bladder Cancer Group (IBCG) stratification.
We retrospectively evaluated 174 LG IR-NMIBC patients who underwent transurethral resection of bladder tumor (index TURBT) from 2012 to 2023 at a tertiary referral center and fulfilled the inclusion criteria for enrollment in AS protocols at the index TURBT (≤ 5 suspicious lesions, no macrohematuria, negative urine cytology, lesions ≤ 1 cm). Patients were then stratified according to the International Bladder Cancer Group (IBCG) risk factors: frequent recurrence, early recurrence, previous instillation, and multifocality. Kaplan Meier plots and multivariable Cox regression analysis (MVA) were used to assess the risk of any and high-grade (HG) recurrence according to the number of risk factors.
Overall, 168 (97%) patients had a Ta low grade bladder tumor. After a median follow-up of 36 months [Interquartile range (IQR) 20-54], 75 (43%) and 32 (18%) patients experienced any- and HG recurrence, respectively. The 3-year recurrence free-survival (RFS) was 86% [95% Confidence Interval (CI) 76-98%] for patients with 0, 76% (95% CI 68-84%) for those with 1-2, and 54% (95% CI 34-84%) for those with ≥ 3 risk factors. The 3-year HG-RFS was > 90% for patients with 0 and 1-2 risk factors, compared to 76% (95% CI 58-99%) for those with ≥ 3 risk factors. At MVA, the presence of ≥ 3 risk factors was associated with a higher risk of recurrence [hazard ratio: 4.74, 95% CI 1.75-12.8, p = 0.002].
Among patients with LG IR-NMIBC eligible for AS, those with more than 2 IBCG risk factors may not be suitable candidates due to a higher risk of developing HG recurrence. Randomized controlled trials with standardized AS protocols are necessary to validate these findings and optimize patient selection for AS in LG IR-NMIBC.
中危非肌层浸润性膀胱癌（IR-NMIBC）预后组具有异质性。越来越多的证据支持对低危NMIBC患者进行主动监测（AS），然而，关于IR-NMIBC尚无明确数据。本研究的目的是根据国际膀胱癌小组（IBCG）分层评估适合AS的患者的复发风险。
我们回顾性评估了2012年至2023年在一家三级转诊中心接受经尿道膀胱肿瘤切除术（初次TURBT）的174例低级别IR-NMIBC患者，这些患者在初次TURBT时符合AS方案纳入标准（≤5个可疑病变、无肉眼血尿、尿细胞学阴性、病变≤1 cm）。然后根据国际膀胱癌小组（IBCG）风险因素对患者进行分层：频繁复发、早期复发、既往灌注治疗和多灶性。采用Kaplan-Meier曲线和多变量Cox回归分析（MVA）根据风险因素数量评估任何复发和高级别（HG）复发的风险。
总体而言，168例（97%）患者为Ta低级别膀胱肿瘤。中位随访36个月[四分位间距（IQR）20-54]后，分别有75例（43%）和32例（18%）患者出现任何复发和HG复发。0个风险因素的患者3年无复发生存率（RFS）为86%[95%置信区间（CI）76-98%]，1-2个风险因素的患者为76%（95%CI 68-84%），≥3个风险因素的患者为54%（95%CI 34-84%）。0个和1-2个风险因素的患者3年HG-RFS>90%，而≥3个风险因素的患者为76%（95%CI 58-99%）。在MVA中，≥3个风险因素的存在与更高的复发风险相关[风险比：4.74，95%CI 1.75-12.8，p=0.002]。
在适合AS的低级别IR-NMIBC患者中，具有超过2个IBCG风险因素的患者可能因发生HG复发的风险较高而不是合适的AS候选者。需要采用标准化AS方案的随机对照试验来验证这些发现，并优化低级别IR-NMIBC患者AS的患者选择。
