The ROMA (Risk of Ovarian Malignancy Algorithm) for estimating the risk of epithelial ovarian cancer in women presenting with pelvic mass: is it really useful?
The ROMA (Risk of Ovarian Malignancy Algorithm) for estimating the risk of epithelial ovarian cancer in women presenting with pelvic mass: is it really useful?
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DOI：
10.1515/cclm.2011.075
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发表时间：
2011-03-01
影响因子：
6.8
通讯作者：
Guidi, Gian Cesare
中科院分区：
文献类型：
--
作者：
Montagnana, Martina;Danese, Elisa;Guidi, Gian Cesare
背景资料：该研究旨在评估预测模型ROMA的性能（卵巢癌风险算法），该算法利用人类附睾蛋白4（HE 4）和CA 125值的组合来评估患有盆腔肿块的女性患上皮性卵巢癌（EOC）的风险。方法：104名被诊断为盆腔肿块的女性（55名EOC和49名良性病例）和49名健康女性（沿着）被纳入研究。术前测定血清HE 4和CA 125浓度。绝经前和绝经后妇女的单独逻辑回归算法ROMA用于将患者分为EOC的低风险组和高风险组。结果：卵巢上皮性癌患者血清中CA 125和HE 4浓度的中位数均显著高于健康女性（均P < 0.05）和良性肿块患者（均P <0.05）;绝经前组包括36例良性病例（其中29例被ROMA归类为低风险，特异性为80.6%; 95%CI：64.0%-91.8%）和15例EOC（其中8例被ROMA归类为高风险，敏感性为53.3%; 95%CI：26.6%-78.7%）。绝经后组包括13例良性病例（其中11例被ROMA归类为低风险，特异性为84.6%; 95%CI：54.6%-98.0%）和40例EOC（其中33例被ROMA归类为高风险，敏感性为82.5%; 95%CI：67.2%-92.7%）。在绝经前组中，CA 125的AUC为0.64（p=0.12，95% CI：0.44-0.83），HE 4为0.77（p=0.003，95% CI：0.62-0.92），ROMA为0.77（p=0.002，95% CI：0.63-0.92）。在绝经后组中，AUC为0.84（p=0.0003，95% CI：0.73-0.94）对于CA 125，0.94（p= 0.0001，95% CI：0.88-0.99），对于HE 4和0.92结论：ROMA是一个简单的评分系统，它对绝经后妇女EOC的检测显示出极好的诊断性能，但对绝经前妇女则不然。此外，HE 4和CA 125（ROMA）的双标志物组合没有显示出比单独的HE 4更好的性能。
Background: The study is aimed at evaluating the performance of the predictive model ROMA (Risk of Ovarian Malignancy Algorithm), which utilizes the combination of human epididymis protein 4 (HE4) and CA125 values to assess the risk of epithelial ovarian cancer (EOC) in women with a pelvic mass.Methods: One hundred and four women diagnosed with a pelvic mass (55 EOC and 49 benign cases) and scheduled to have surgery were enrolled, along with 49 healthy females. Preoperative serum concentrations of HE4 and CA125 were measured. Separate logistic regression algorithms ROMA for pre-menopausal and post-menopausal women were used to categorize patients into low-and high-risk groups for EOC. The area under the curve (AUC), sensitivity and specificity were calculated for HE4, CA125 and ROMA for the diagnosis of ovarian cancer using receiver operating characteristic (ROC) analysis.Results: The median CA125 and HE4 serum concentrations were significantly higher among EOC patients than in healthy females (both p < 0.05) and those with a benign mass (both p < 0.05). The pre-menopausal group included 36 benign cases (29 of which were classified by ROMA as low-risk with a specificity of 80.6%; 95% CI: 64.0%-91.8%), and 15 EOC (eight of which were classified by ROMA as high-risk, with a sensitivity of 53.3%; 95% CI: 26.6%-78.7%). The post-menopausal group enclosed 13 benign cases (11 of which were classified by ROMA as low-risk with a specificity of 84.6%; 95% CI: 54.6%-98.0%), and 40 EOC (33 of which were classified by ROMA as high-risk with a sensitivity of 82.5%; 95% CI: 67.2%-92.7%). In the pre-menopausal group, the AUC was 0.64 (p=0.12, 95% CI: 0.44-0.83) for CA125, 0.77 (p=0.003, 95% CI: 0.62-0.92) for HE4 and 0.77 (p=0.002, 95% CI: 0.63-0.92) for ROMA. In the post-menopausal group, the AUC was 0.84 (p=0.0003, 95% CI: 0.73-0.94) for CA125, 0.94 (p=.0001, 95% CI: 0.88-0.99) for HE4 and 0.92 (p < 0.0001, 95% CI: 0.85-0.99) for ROMA.Conclusions: The ROMA is a simple scoring system which shows excellent diagnostic performance for the detection of EOC in post-menopausal women, but not in pre-menopausal women. Moreover, the dual marker combination of HE4 and CA125 (ROMA) does not show better performance than HE4 alone.