Shittu Khadijah Adebisi, Rabiu Kabiru Afolarin, Akinola Oluwarotimi Ireti, Ahmed Saheed Bolaji, Adewunmi Adeniyi Abiodun
Department of Obstetrics and Gynaecology, Lagos State University Teaching Hospital, Ikeja 100271, Lagos State, Nigeria.
Department of Obstetrics and Gynaecology, Lagos State University College of Medicine, Ikeja 100271, Lagos State, Nigeria.
Ecancermedicalscience. 2023 Jul 5;17:1568. doi: 10.3332/ecancer.2023.1568. eCollection 2023.
This prospective cross-sectional study compared the diagnostic accuracy of human epididymal protein 4 (HE4) with cancer antigen 125 (CA 125) and validates the risk of malignancy algorithm (ROMA) in differentiating benign from malignant ovarian tumours. The study population included 112 women with an ultrasound diagnosis of an adnexal mass, out of whom 49 women had a diagnosis of ovarian cancer following optimal debulking surgery, and 63 women had a diagnosis of benign ovarian tumour. All diagnosis was confirmed by histopathological analysis. Serum HE4 and CA 125 were assessed preoperatively according to the manufacturer's instructions. CA 125 and HE4 cut-offs were 35 U/mL and 70 pM/L respectively. Serum CA 125 and HE4 were significantly higher in ovarian cancer patients compared to those with benign ovarian tumours ( < 0.001 and < 0.000, respectively). HE4 had higher sensitivity (77.5% versus 69.4%), specificity (96.8% versus 82.5%), positive predictive value (PPV) (95% versus 75.6%) and negative predictive value (84.7% versus 77.6%) than CA 125. When the two markers were combined with each other in the ROMA index, Specificity and PPV reached 100% each. In the receiver operative characteristics analysis, the area under the curve for CA 125 was 0.679 (95% CI 0.566-0.791, = 0.001), HE4 was 0.845 (95% CI 0.760-0.930, = 0.000) and ROMA was 0.902 (95% CI 0.851-0.998, = 0.000) and this was statistically significant ( < 0.001). Conclusively, HE4 performed better than CA 125 in differentiating benign from malignant ovarian tumours and the combination of the two biomarkers improved the detection of ovarian cancer. In addition, the cut off values corresponding to the highest accuracy for CA 125 and HE4 were 126 U/mL and 42 pM/L respectively in this study. The value for CA 125 is much higher while that of HE4 is much lower than the reference values obtained predominantly from the white population.
这项前瞻性横断面研究比较了人附睾蛋白4（HE4）与癌抗原125（CA 125）的诊断准确性，并验证了恶性风险算法（ROMA）在鉴别卵巢良性肿瘤与恶性肿瘤方面的作用。研究人群包括112名经超声诊断为附件包块的女性，其中49名女性在接受最佳肿瘤细胞减灭术后被诊断为卵巢癌，63名女性被诊断为卵巢良性肿瘤。所有诊断均经组织病理学分析证实。术前按照制造商的说明对血清HE4和CA 125进行评估。CA 125和HE4的临界值分别为35 U/mL和70 pM/L。与卵巢良性肿瘤患者相比，卵巢癌患者的血清CA 125和HE4显著更高（分别为<0.001和<0.000）。HE4在敏感性（77.5%对69.4%）、特异性（96.8%对82.5%）、阳性预测值（PPV）（95%对75.6%）和阴性预测值（8�.7%对77.6%）方面均高于CA 125。当将这两种标志物结合纳入ROMA指数时，特异性和PPV均达到100%。在受试者工作特征分析中，CA 125的曲线下面积为0.679（95%CI 0.566 - 0.791，P = 0.001），HE4为0.845（95%CI 0.760 - 0.930，P = 0.000），ROMA为0.902（95%CI 0.851 - 0.998，P = 0.000），且具有统计学意义（P < 0.001）。总之，在鉴别卵巢良性肿瘤与恶性肿瘤方面，HE4的表现优于CA 125，两种生物标志物的联合使用提高了卵巢癌的检测率。此外，在本研究中，CA 125和HE4对应最高准确性的临界值分别为126 U/mL和42 pM/L。CA 125的值远高于而HE4的值远低于主要从白种人群获得的参考值。
