Lin Hao, Fu Hung-Chun, Huang Szu-Yu, Wu Chen-Hsuan, Huang Szu-Wei, Wang Shao-Chi, Ou Yu-Che
Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
School of Medicine, College of Medicine, National Sun Yat-Sen University, Kaohsiung, Taiwan.
Cancer Biomark. 2025 Mar;42(3):18758592241306265. doi: 10.1177/18758592241306265. Epub 2025 Apr 4.
BackgroundWe previously utilized pretreatment tumor markers Carcinoembryonic Antigen (CEA) and Cancer Antigen 125 (CA125) for predicting lymph node metastasis (LNM) in endometrioid endometrial cancer (EC).ObjectiveThe aim of this study was to externally validate a nomogram developed in our previous single-center retrospective study.MethodsA multi-center validation study was conducted to recruit endometrioid EC patients from four branches of Chang Gung Memorial Hospital between 2009 and 2021, with patients participating in the original research being excluded. The previously established nomogram was applied with optimal cut-off values for CEA 1.4 ng/ml and CA125 40 U/mL identified through receiver operating characteristic (ROC) curves. The concordance index (C-index) was calculated to assess discrimination, and comparative negative predictive value (NPV) and negative likelihood ratio (NLR) were determined. Decision curve analysis (DCA) was plotted to evaluate our predictive model's clinical utility and net benefit.ResultsOverall, 1271 patients were included in this external validation study. The results demonstrated a C-index of 0.727, indicating moderate discrimination ability of the nomogram in predicting LNM in this independent cohort. Comparative analysis of NPV 97.2% and NLR 0.36 revealed performance metrics consistent with the original study, reinforcing the nomogram's potential clinical utility in ruling out the possibility of LNM if both pretreatment CEA and CA125 were less than 1.4 ng/ml and 40 U/mL, respectively. The DCA indicated that the nomogram provided clinical utility.ConclusionThe reproducible performance metrics in the independent large sample cohort underscore the robustness and generalizability of utilizing CEA and CA125 as predictors of LNM in endometrioid EC, suggesting its potential as a simple tool for clinicians in preoperative decision-making regarding lymphadenectomy.
背景
我们之前利用治疗前肿瘤标志物癌胚抗原（CEA）和癌抗原125（CA125）来预测子宫内膜样子宫内膜癌（EC）中的淋巴结转移（LNM）。
目的
本研究的目的是对我们之前单中心回顾性研究中开发的列线图进行外部验证。
方法
进行了一项多中心验证研究，以招募2009年至2021年间来自长庚纪念医院四个分院的子宫内膜样EC患者，参与原始研究的患者被排除。应用先前建立的列线图，并通过受试者操作特征（ROC）曲线确定CEA的最佳临界值为1.4 ng/ml，CA125的最佳临界值为40 U/mL。计算一致性指数（C指数）以评估区分度，并确定比较阴性预测值（NPV）和阴性似然比（NLR）。绘制决策曲线分析（DCA）以评估我们预测模型的临床实用性和净效益。
结果
总体而言，1271名患者纳入了这项外部验证研究。结果显示C指数为0.727，表明该列线图在预测这个独立队列中的LNM方面具有中等区分能力。NPV为97.2%和NLR为0.36的比较分析显示性能指标与原始研究一致，强化了如果治疗前CEA和CA125分别低于1.4 ng/ml和40 U/mL，该列线图在排除LNM可能性方面的潜在临床实用性。DCA表明该列线图具有临床实用性。
结论
独立大样本队列中可重复的性能指标强调了利用CEA和CA125作为子宫内膜样EC中LNM预测指标的稳健性和普遍性，表明其作为临床医生术前关于淋巴结清扫决策的简单工具的潜力。
