A multicenter clinical trial validating the performance of HE4, CA125, risk of ovarian malignancy algorithm and risk of malignancy index
A multicenter clinical trial validating the performance of HE4, CA125, risk of ovarian malignancy algorithm and risk of malignancy index
复制标题
一项验证HE4、CA125、卵巢恶性肿瘤风险算法和恶性肿瘤风险指数性能的多中心临床试验
DOI：
10.1016/j.ygyno.2018.08.025
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发表时间：
2018-10-01
影响因子：
4.7
通讯作者：
Sundfeldt, Karin
中科院分区：
文献类型：
--
作者：
Lycke, Maria;Kristjansdottir, Bjorg;Sundfeldt, Karin
Objective.在一项多中心临床试验中验证生物标志物和算法在诊断为未知卵巢囊肿或盆腔肿瘤的女性人群中的鉴别诊断性能。2013年9月至2016年2月，瑞典西部的六家医院连续招募了638名女性。术前收集血清、经阴道超声数据和患者基本特征。计算生物标志物水平、恶性风险算法（ROMA）和恶性风险指数（RMI），并与最终病理报告进行比较。我们的样本638例患者有445良性，31交界性和162恶性肿瘤记录，和上皮性卵巢癌的总发病率为21%。在绝经后妇女中，RMI（>200）、ROMA（>= 29.9）、CA 125（>35 U/mL）和HE 4（>140 pmol/L）的敏感性分别为89%、91%、92%和72%，特异性分别为80%、77%、80%和92%。在绝经前妇女中，RMI、ROMA（>= 11.6）、CA 125和HE 4（>70 pmol/L）的敏感性分别为87%、87%、96%和83%，特异性分别为90%、81%、60%和91%。RMI和ROMA对绝经后妇女的诊断准确性（ROC AUC）分别为0.85和0.84，绝经前妇女分别为0.90和0.81。我们的研究结果表明，CA 125是上级比HE 4作为一个生物标志物，以确定妇女与卵巢癌。HE 4更准确地识别良性病变，这可能有助于鉴别诊断，以指导护理水平并减少过度治疗。本研究证实了单中心研究的先前结果，并建议在日常实践中实施HE 4测量。(C)2018爱思唯尔公司All rights reserved.
Objective. To validate, in a multicenter clinical trial, the performance of biomarkers and algorithms for differential diagnosis in a population of women diagnosed with an unknown ovarian cyst or pelvic tumor.Methods. Six hospitals in Western Sweden consecutively enrolled 638 women from September 2013 to February 2016. Serum, transvaginal ultrasound data, and basic patient characteristics were collected preoperatively. Biomarker levels, risk of malignancy algorithm (ROMA), and risk of malignancy index (RMI) were calculated and compared with the final pathology report.Results. Our sample of 638 patients had 445 benign, 31 borderline, and 162 malignant tumors recorded, and the overall incidence of epithelial ovarian cancer was 21%. In postmenopausal women, RMI (>200), ROMA (>= 29.9), CA125 (>35 U/mL), and HE4 (>140 pmol/L) showed sensitivity at 89%, 91%, 92%, and 72%, respectively, and specificity at 80%, 77%, 80%, and 92%. In premenopausal women, sensitivity of RMI, ROMA (>= 11.6), CA125, and HE4 (>70 pmol/L) was 87%, 87%, 96%, and 83%, respectively, and specificity was 90%, 81%, 60%, 91%. Diagnostic accuracy (ROC AUC) of RMI and ROMA in postmenopausal women was 0.85 and 0.84, and in premenopausal women, 0.90 and 0.81.Conclusion. Our results suggest that CA125 is superior to HE4 as a biomarker to identify women with ovarian cancer. HE4 more correctly identifies benign lesions, which may help in differential diagnoses to guide the level of care and decrease overtreatment. This study confirms prior results from single-center studies and suggests the implementation of HE4 measurement in daily practice. (C) 2018 Elsevier Inc. All rights reserved.