HE4 作为盆腔肿块诊断的血清标志物：一项 965 例患者的前瞻性多中心研究。

HE4 as a serum biomarker for the diagnosis of pelvic masses: a prospective, multicenter study in 965 patients.

机构信息

Department of Gynecology with Center of Oncological Surgery, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany.

Department of Obstetrics and Gynecology, Stanford University, California, USA.

出版信息

BMC Cancer. 2022 Jul 30;22(1):831. doi: 10.1186/s12885-022-09887-5.

BACKGROUND

To evaluate the diagnostic value of adding human epididymis protein 4 (HE4), cancer antigen 125 (CA125) and risk of malignancy algorithm (ROMA) to ultrasound for detecting ovarian cancer in patients with a pelvic mass.

METHODS

This was a prospective, observational, multicenter study. Patients aged > 18 years who were scheduled to undergo surgery for a suspicious pelvic mass had CA125 and HE4 levels measured prior to surgery, in addition to a routine transvaginal ultrasound scan. The diagnostic performance of CA125, HE4 and ROMA for distinguishing between benign and malignant adnexal masses was assessed using receiver operating characteristic (ROC) analysis and the corresponding area under the curve (AUC).

RESULTS

Of 965 evaluable patients, 804 were diagnosed with benign tumors and 161 were diagnosed with ovarian cancer. In late-stage ovarian cancer, CA125, HE4 and ROMA all had an excellent diagnostic performance (AUC > 0.92), whereas in stage I and II, diagnostic performance of all three biomarkers was less adequate (AUC < 0.77). In the differential diagnosis of ovarian cancer and endometriosis, ROMA and HE4 performed better than CA125 with 99 and 98.1% versus 75.0% sensitivity, respectively, at 75.4% specificity.

CONCLUSIONS

ROMA and HE4 could be valuable biomarkers to help with the diagnosis of ovarian cancer in premenopausal patients in order to differentiate from endometriosis, whereas CA125 may be more adequate for postmenopausal patients.

背景

评估在超声检查的基础上添加人附睾蛋白 4（HE4）、癌抗原 125（CA125）和恶性肿瘤风险算法（ROMA）对盆腔肿块患者卵巢癌的诊断价值。

方法

这是一项前瞻性、观察性、多中心研究。年龄>18 岁、因疑似盆腔肿块拟行手术的患者在术前除了进行常规经阴道超声检查外，还检测 CA125 和 HE4 水平。采用受试者工作特征（ROC）分析和相应的曲线下面积（AUC）评估 CA125、HE4 和 ROMA 对鉴别良恶性附件肿块的诊断性能。

结果

在 965 例可评估患者中，804 例诊断为良性肿瘤，161 例诊断为卵巢癌。在晚期卵巢癌中，CA125、HE4 和 ROMA 均具有出色的诊断性能（AUC>0.92），而在 I 期和 II 期，三种生物标志物的诊断性能均不理想（AUC<0.77）。在卵巢癌和子宫内膜异位症的鉴别诊断中，ROMA 和 HE4 的性能优于 CA125，其特异性分别为 99%和 98.1%，敏感性分别为 75.0%。