Angelopoulos Panagiotis, Markopoulos Titos, Lazarou Lazaros, Skolarikos Andreas, Stamatakos Panagiotis, Papadopoulos Georgios I, Fragkoulis Charalampos, Ntoumas Konstantinos, Moulavasilis Napoleon, Levis Panagiotis, Papanikolaou Dimitrios, Sokolakis Ioannis, Hatzimouratidis Konstantinos, Tzanetakos Charalampos, Psarra Marina, Mavridoglou George, Skriapas Konstantinos, Akrivou Dimitra, Karagiannis Dimitrios, Noutsos Christos, Georgiou Andreas, Hastazeris Konstantinos, Gourzoulidis George, Mitropoulos Dionysios
2nd Department of Urology, Sismanogleio Hospital, Medical School, National and Kapodistrian University of Athens, 15126 Athens, Greece.
Department of Urology, General Hospital of Athens G. Gennimatas, 11527 Athens, Greece.
Curr Oncol. 2024 Dec 29;32(1):18. doi: 10.3390/curroncol32010018.
While the clinical application of SII-ONCO-Bacillus Calmette-Guerin (BCG) for non-muscle-invasive bladder cancer (NMIBC) is well established in Greece, there is a lack of real-world data on its effectiveness and safety. This retrospective, observational, multicenter, chart-review study aims to provide real-life data on the effectiveness and safety of SII-ONCO-BCG in patients with intermediate- and high-risk NMIBC.
From January 2016 to December 2023, medical records from six hospital centers were reviewed for adult patients with histologically confirmed stage Ta or T1 NMIBC (with or without carcinoma in situ [CIS]) who received at least one maintenance course of SII-ONCO-BCG after induction. Tumor recurrence and progression were monitored at scheduled time intervals. Primary outcomes included recurrence-free survival (RFS) and progression-free survival (PFS), while adverse events (AEs) constituted secondary outcomes.
A total of 162 patients receiving SII-ONCO-BCG were enrolled. Among all patients, 145 (89.5%) patients were men, 88 (54.3%) aged 70 years or older, 103 (63.6%) had T1, 43 (26.5%) Ta, and 21 (12.9%) concurrent CIS. The median follow-up duration was 28.9 months (range, 5-36) and the mean BCG intravesical instillation courses were 13.7 (range, 9-27). After 3-, 2-, and 1-year follow-up, RFS rates of 85.2% (95% CI, 79.7-90.7%), 85.8% (80.4-91.2%), and 87.0% (81.8-92.3%) were observed, respectively. The corresponding 3-, 2-, and 1-year PFS rates were 96.9% (94.2-99.6%), 96.9% (94.2-99.6%), and 97.5% (95.1-99.9%), respectively. During the whole follow-up period, 24 (14.8%) patients experienced at least one AE.
This real-world study demonstrates that SII-ONCO-BCG is an effective and safe treatment for patients with intermediate- and high-risk NMIBC.
虽然SII-ONCO-卡介苗（BCG）在希腊用于非肌层浸润性膀胱癌（NMIBC）的临床应用已得到充分确立，但缺乏关于其有效性和安全性的真实世界数据。这项回顾性、观察性、多中心、病历审查研究旨在提供SII-ONCO-BCG在中高危NMIBC患者中有效性和安全性的真实生活数据。
回顾了2016年1月至2023年12月期间六个医院中心的医疗记录，纳入组织学确诊为Ta或T1期NMIBC（伴或不伴原位癌[CIS]）且诱导治疗后接受至少一个疗程SII-ONCO-BCG维持治疗的成年患者。定期监测肿瘤复发和进展情况。主要结局包括无复发生存期（RFS）和无进展生存期（PFS），不良事件（AE）为次要结局。
共纳入162例接受SII-ONCO-BCG治疗的患者。所有患者中，145例（89.5%）为男性，88例（54.3%）年龄在70岁及以上，103例（63.6%）为T1期，43例（26.5%）为Ta期，21例（12.9%）合并CIS。中位随访时间为28.9个月（范围5 - 36个月），卡介苗膀胱内灌注疗程平均为13.7次（范围9 - 27次）。在3年、2年和1年随访后，观察到的RFS率分别为85.2%（95%CI，79.7 - 90.7%）、85.8%（80.4 - 91.2%）和87.0%（81.8 - 92.3%）。相应的3年、2年和1年PFS率分别为96.9%（94.2 - 99.6%）、96.9%（94.2 - 99.6%）和97.5%（95.1 - 99.9%）。在整个随访期间，24例（14.8%）患者经历了至少一次AE。
这项真实世界研究表明，SII-ONCO-BCG是治疗中高危NMIBC患者的一种有效且安全的疗法。
