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附件包块患者转至肿瘤专科治疗的风险模型的临床实用性:使用决策曲线分析的多中心外部验证。

Clinical Utility of Risk Models to Refer Patients with Adnexal Masses to Specialized Oncology Care: Multicenter External Validation Using Decision Curve Analysis.

机构信息

Department of Development and Regeneration, KU Leuven, Leuven, Belgium.

Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium.

出版信息

Clin Cancer Res. 2017 Sep 1;23(17):5082-5090. doi: 10.1158/1078-0432.CCR-16-3248. Epub 2017 May 16.

Abstract

To evaluate the utility of preoperative diagnostic models for ovarian cancer based on ultrasound and/or biomarkers for referring patients to specialized oncology care. The investigated models were RMI, ROMA, and 3 models from the International Ovarian Tumor Analysis (IOTA) group [LR2, ADNEX, and the Simple Rules risk score (SRRisk)]. A secondary analysis of prospectively collected data from 2 cross-sectional cohort studies was performed to externally validate diagnostic models. A total of 2,763 patients (2,403 in dataset 1 and 360 in dataset 2) from 18 centers (11 oncology centers and 7 nononcology hospitals) in 6 countries participated. Excised tissue was histologically classified as benign or malignant. The clinical utility of the preoperative diagnostic models was assessed with net benefit (NB) at a range of risk thresholds (5%-50% risk of malignancy) to refer patients to specialized oncology care. We visualized results with decision curves and generated bootstrap confidence intervals. The prevalence of malignancy was 41% in dataset 1 and 40% in dataset 2. For thresholds up to 10% to 15%, RMI and ROMA had a lower NB than referring all patients. SRRisks and ADNEX demonstrated the highest NB. At a threshold of 20%, the NBs of ADNEX, SRrisks, and RMI were 0.348, 0.350, and 0.270, respectively. Results by menopausal status and type of center (oncology vs. nononcology) were similar. All tested IOTA methods, especially ADNEX and SRRisks, are clinically more useful than RMI and ROMA to select patients with adnexal masses for specialized oncology care. .

摘要

评估基于超声和/或生物标志物的卵巢癌术前诊断模型在将患者转介至专科肿瘤治疗中的效用。所研究的模型包括 RMI、ROMA 以及国际卵巢肿瘤分析(IOTA)组的 3 种模型[LR2、ADNEX 和简单规则风险评分(SRRisk)]。对来自 2 项横断面队列研究的前瞻性收集数据进行了二次分析,以对诊断模型进行外部验证。共有来自 6 个国家 18 个中心(11 个肿瘤中心和 7 个非肿瘤医院)的 2763 名患者(数据集 1 中 2403 名,数据集 2 中 360 名)参与了研究。切除的组织经组织学分类为良性或恶性。使用净效益(NB)评估术前诊断模型在一系列风险阈值(恶性肿瘤风险 5%-50%)下的临床效用,以将患者转介至专科肿瘤治疗。我们使用决策曲线和生成的自举置信区间来可视化结果。数据集 1 中恶性肿瘤的患病率为 41%,数据集 2 中为 40%。在阈值为 10%-15%的情况下,RMI 和 ROMA 的 NB 低于所有患者的转介率。SRRisks 和 ADNEX 显示出最高的 NB。在阈值为 20%时,ADNEX、SRrisks 和 RMI 的 NB 分别为 0.348、0.350 和 0.270。根据绝经状态和中心类型(肿瘤与非肿瘤)的结果相似。所有测试的 IOTA 方法,尤其是 ADNEX 和 SRRisks,在选择附件肿块患者进行专科肿瘤治疗方面比 RMI 和 ROMA 更具临床实用性。

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