Purpose:Bladder cancer (BC) is a heterogeneous disease with varying outcomes, influenced by disease heterogeneity and variability in treatment and follow-up. Risk groups have been established for non–muscle-invasive BC (NMIBC) to standardize therapy, and several quality control indicators (QCIs) monitor adherence to these risk group-based guidelines. However, controversial results had been obtained regarding the oncological benefits of these QCIs until recent high-quality studies from large registries showed their usefulness. To improve adherence to the European Association of Urology (EAU) Guidelines and benchmark current care in Flemish hospitals within Vlaams Ziekenhuisnetwerk–KU Leuven (VZNKUL), a QCI program for NMIBC was initiated in 2013. This study aims to describe the demographic, clinical, and treatment data of patients enrolled in this program.Participants:The VZNKUL–NMIBC Quality Indicators Program Registry is a prospective cohort including patients treated and followed up with at seven academic and non-academic Flemish hospitals since June 2013. Data collection includes patient characteristics, tumor data, treatment, and oncological outcomes.Findings to date:From June 2013 to December 2020, 4744 transurethral resections of bladder tumors (TURBTs) from 2237 unique patients were analyzed. Most patients (80%) were men with a median age of 73. The median time from diagnosis to TURBT was 19 days. A single tumor was detected in 37% of TURBTs. Tumors larger than 3 cm were found in 20.8% of cases. In 46% of TURBTs, a reTURBT was scheduled according to guidelines. The complication rates were 7.5% and 2.4% for bladder perforation and bleeding, respectively. Postoperative single intravesical instillation of chemotherapy (SIVIC) was administered to 56.9% of 1533 indicated patients with a median time to administration of 4.7 h. Among the cohort, 60.4% had NMIBC, and 9.3% had muscle-invasive BC. Of 972 high-risk patients, 60.7% received adequate BCG induction, while 39.4% received adequate maintenance. After BCG induction ± maintenance, 39.7% were tumor-free, with 17.7% recurrence and 4% progression to muscle-invasive BC. BCG treatment was terminated early for 17% of patients due to intolerance. Early cystectomy was performed for 2.4% of the BCG-naïve patients, and 27.7% of patients with BCG failure underwent a BCG rechallenge. For intermediate-risk patients, 2.1% received adequate BCG, and 23% received intravesical chemotherapy. The median follow-up was 57 months. Five-year recurrence-free, progression-free, cancer-free, overall, and cancer-specific survival rates were 53%, 91.6%, 89%, 70.6%, and 95.6%, respectively, for the NMIBC patients. Of 400 non-metastatic MIBC patients, 217 (54.3%) underwent radical cystectomy (RC), of whom 46% received neoadjuvant chemotherapy, while 18 (4.5%) refused RC, and 74 (18.5%) were considered unfit for the surgery.Future plans:The VZNKUL–NMIBC Quality Indicators Program Registry will continue collecting data to evaluate QCIs and monitor treatment quality, enabling hospitals to benchmark their performance and improve patient care. Additionally, the registry’s real-world data can support research and international collaboration.Trial registration:The study was registered on ClinicalTrials.gov (NCT04167332).
目的：膀胱癌是一种异质性疾病，其预后受疾病异质性及治疗与随访差异的影响。为规范治疗，已为非肌层浸润性膀胱癌建立了风险分组，并通过多项质量控制指标监测基于风险分组的指南依从性。然而，关于这些质量控制指标的肿瘤学获益一直存在争议，直至近期大型注册研究的高质量证据证实了其价值。为提高对欧洲泌尿外科学会指南的依从性，并在弗拉芒医院网络-鲁汶大学联盟内建立当前诊疗的基准，弗拉芒地区于2013年启动了非肌层浸润性膀胱癌质量控制指标项目。本研究旨在描述参与该项目的患者人口学、临床及治疗数据。 研究对象：弗拉芒医院网络-鲁汶大学联盟非肌层浸润性膀胱癌质量控制指标项目注册库为前瞻性队列，纳入自2013年6月起在七家弗拉芒学术与非学术医院接受治疗及随访的患者。数据收集涵盖患者特征、肿瘤信息、治疗方案及肿瘤学结局。 当前发现：2013年6月至2020年12月期间，共分析了2237例独特患者的4744次经尿道膀胱肿瘤切除术。大多数患者（80%）为男性，中位年龄73岁。从诊断到手术的中位时间为19天。37%的切除术中发现单发肿瘤。20.8%的病例肿瘤直径大于3厘米。根据指南，46%的切除术计划进行二次切除术。膀胱穿孔和出血并发症发生率分别为7.5%和2.4%。在1533例适应症患者中，56.9%接受了术后单次膀胱灌注化疗，中位给药时间为4.7小时。队列中60.4%为非肌层浸润性膀胱癌，9.3%为肌层浸润性膀胱癌。972例高危患者中，60.7%接受了足量卡介苗诱导治疗，39.4%接受了足量维持治疗。卡介苗诱导治疗±维持治疗后，39.7%患者无肿瘤残留，17.7%复发，4%进展为肌层浸润性膀胱癌。17%患者因不耐受提前终止卡介苗治疗。2.4%的卡介苗初治患者接受了早期膀胱切除术，27.7%的卡介苗治疗失败患者接受了卡介苗再挑战治疗。中危患者中，2.1%接受了足量卡介苗治疗，23%接受膀胱灌注化疗。中位随访时间57个月。非肌层浸润性膀胱癌患者的5年无复发生存率、无进展生存率、无癌生存率、总生存率和癌症特异性生存率分别为53%、91.6%、89%、70.6%和95.6%。400例非转移性肌层浸润性膀胱癌患者中，217例（54.3%）接受根治性膀胱切除术，其中46%接受新辅助化疗；18例（4.5%）拒绝手术；74例（18.5%）因身体状况不适合手术。 未来计划：弗拉芒医院网络-鲁汶大学联盟非肌层浸润性膀胱癌质量控制指标项目注册库将持续收集数据以评估质量控制指标并监测治疗质量，助力医院进行绩效对标并提升患者照护水平。此外，该注册库的真实世界数据可为科研与国际合作提供支持。 试验注册：本研究已在ClinicalTrials.gov注册（NCT04167332）。
肿瘤(癌症)患者之家