Research
Oncology
Human epididymis protein 4 offers superior specificity in the differentiation of benign and malignant adnexal masses in premenopausal women

Presented as a poster at the 2011 Annual Meeting on Women's Cancer of the Society for Gynecologic Oncology, Orlando, FL, March 6-9, 2011.
https://doi.org/10.1016/j.ajog.2011.05.017Get rights and content

Objective

We sought to assess the ability of human epididymis protein 4 (HE4) and CA-125 to distinguish among benign, borderline, and malignant pelvic masses in premenopausal women.

Study Design

We conducted a subset analysis of data from a prospective clinical trial that enrolled women undergoing surgery for an adnexal mass. Diagnostic performance of CA-125 and HE4 for epithelial ovarian cancer (EOC) detection in premenopausal women was determined.

Results

Of 229 premenopausal patients, 195 (85%) had benign masses, 18 (8%) had EOC, and 16 (7%) had borderline ovarian tumor. The sensitivity of CA-125 and HE4 for EOC detection was 83.3% and 88.9%, respectively. The specificity of CA-125 and HE4 was 59.5% and 91.8%, respectively. A normal HE4 level ruled out invasive cancer in 98% of women with an elevated CA-125.

Conclusion

HE4 offers superior specificity compared to CA-125 for the differentiation of benign and malignant adnexal masses in premenopausal women.

Section snippets

Materials and Methods

The study is a subset analysis of serum samples from a prospective, multicenter, double-blind clinical trial that enrolled women ≥18 years of age presenting with a pelvic mass who were scheduled to undergo surgery (ClinicalTrial.gov identifier NCT00315692). It was conducted at 14 clinical sites across the United States from December 2005 through February 2007. The pelvic mass had to be demonstrable on pelvic sonogram, computed tomography scan, or magnetic resonance imaging. Women with a history

Results

In all, 229 premenopausal (46%) and 265 postmenopausal (54%) women comprised the entire study protocol population. The histologic findings stratified by menopausal status are shown in Table 1. Benign masses were predominant in premenopausal women with only 8% being diagnosed with epithelial ovarian cancers (EOC) and 7% with borderline ovarian tumors (BOT). Further analysis was limited to the premenopausal group only. The median serum CA-125 value in the benign cases was 25.6 U/mL (5.1-2462.2

Comment

The serum CA-125 has been the assay of choice in the evaluation of a suspicious adnexal mass.12 However, CA-125 was proven inferior to gray-scale and Doppler ultrasound for the discrimination of benign and malignant pelvic masses in women with a persistent adnexal mass.14 The most common benign gynecologic conditions causing false-positive CA-125 results in the study by Van Calster et al14 were endometriomas (63%) and abscesses (58%), both of which were more common in premenopausal women.

References (25)

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    Z.V. is an employee of Fujirebio Diagnostics, Inc. C.M. and R.C.K. are paid consultants for Fujirebio Diagnostics, Inc.

    This study was supported by Fujirebio Diagnostics Inc, Malvern, PA.

    Cite this article as: Holcomb K, Vucetic Z, Miller MC, et al. Human epididymis protein 4 offers superior specificity in the differentiation of benign and malignant adnexal masses in premenopausal women. Am J Obstet Gynecol 2011;205:358.e1-6.

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