von Deimling Markus, Rink Michael, Klemm Jakob, Koelker Mara, König Frederik, Gild Philipp, Khonsari Maryam, Ludwig Tim A, Marks Phillip, Dahlem Roland, Fisch Margit, Vetterlein Malte W
Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
BJU Int. 2023 Jan;131(1):90-100. doi: 10.1111/bju.15890. Epub 2022 Sep 28.
To validate the pentafecta criteria (PC) proposed by the PROMETRICS group for outcome reporting after radical cystectomy in an open radical cystectomy (ORC) cohort with long-term follow-up and to assess the discriminative ability of PC attainment for oncological endpoints.
Between January 2009 and December 2017, 420 patients underwent ORC with pelvic lymph node dissection and urinary diversion for non-metastatic bladder cancer. The PC were defined as reported by the PROMETRICS group. The primary endpoint was PC attainment, and oncological outcomes comprised further endpoints. We used uni- and multivariable logistic regression analysis to assess predictors of PC attainment. The discriminative ability of PC for overall mortality (OM), cancer-specific mortality (CSM) and other-cause mortality (OCM) was compared using Kaplan-Meier curves and cumulative incidence functions. After stratification by the number of PC attained, the association between PC attainment and the survival endpoints was tested on multivariable Cox regression and competing-risks models.
A total of 108 patients (26%) fulfilled all PC, while 195 (46%), 77 (18%), 35 (8.3%) and five (1.2%) attained 4/5, 3/5, 2/5 and ≤1/5 PC, respectively. Increasing age-adjusted Charlson comorbidity index (odds ratio [OR] 0.80, P = 0.015) and incontinent diversion (OR 0.38, P = 0.005) were independent predictors of PC non-attainment. The median follow-up was 73 months. PC attainment (≥4/5 vs 3/5 vs ≤2/5 PC attained) was used to stratify patients into groups at significantly different risk of death (P < 0.001). A decreasing number of PC attained (<4/5) was associated with unfavourable survival estimates for both OM and CSM (all P ≤ 0.005) but not for OCM (all P ≥ 0.2).
The PC proposed by the PROMETRICS group represent accurate quality indicators for oncological outcome reporting after ORC for non-metastatic bladder cancer and have a distinct discriminative ability to predict long-term OM and CSM.
在接受开放根治性膀胱切除术(ORC)且有长期随访的队列中验证PROMETRICS小组提出的用于根治性膀胱切除术后结局报告的五要素标准(PC),并评估达到PC对肿瘤学终点的判别能力。
2009年1月至2017年12月期间,420例患者因非转移性膀胱癌接受了ORC及盆腔淋巴结清扫和尿流改道术。PC的定义如PROMETRICS小组所报告。主要终点是达到PC,肿瘤学结局包括其他终点。我们使用单变量和多变量逻辑回归分析来评估达到PC的预测因素。使用Kaplan-Meier曲线和累积发病率函数比较PC对总死亡率(OM)、癌症特异性死亡率(CSM)和其他原因死亡率(OCM)的判别能力。按达到的PC数量分层后,在多变量Cox回归和竞争风险模型上测试达到PC与生存终点之间的关联。
共有108例患者(26%)满足所有PC,而195例(46%)、77例(18%)、35例(8.3%)和5例(1.2%)分别达到4/5、3/5、2/5和≤1/5的PC。年龄调整后的Charlson合并症指数增加(比值比[OR]0.80,P = 0.015)和尿失禁改道(OR 0.38,P = 0.005)是未达到PC的独立预测因素。中位随访时间为73个月。达到PC(≥4/5 vs 3/5 vs ≤2/5达到的PC)用于将患者分层为死亡风险显著不同的组(P < 0.001)。达到的PC数量减少(<4/5)与OM和CSM的不良生存估计相关(所有P≤0.005),但与OCM无关(所有P≥0.2)。
PROMETRICS小组提出的PC代表了非转移性膀胱癌ORC术后肿瘤学结局报告的准确质量指标,并且在预测长期OM和CSM方面具有明显的判别能力。