Diagnostic performance and establishment of reference limits of HE4 in Korean healthy women

Yu, Shinae; Lee, Jin Kyung; Kim, Jae Hoon; Park, Hyosoon; Lee, Mi Yeon; Ryu, Seungho; Kwon, Min‐Jung; Woo, Hee‐Yeon

doi:10.1016/j.ygyno.2016.07.100

Cited by 6 publications

(7 citation statements)

References 37 publications

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“…We observed higher HE4 levels with older age only among women postmenopausal at blood collection. A positive association between age and HE4 has been previously reported (reviewed in [10, 24]). Older age at menopause was positively associated with CA125 concentrations, as has been observed previously [6–8], and inversely associated with HE4.…”

Section: Discussionmentioning

confidence: 93%

Correlates of circulating ovarian cancer early detection markers and their contribution to discrimination of early detection models: results from the EPIC cohort

et al. 2017

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BackgroundOvarian cancer early detection markers CA125, CA15.3, HE4, and CA72.4 vary between healthy women, limiting their utility for screening.MethodsWe evaluated cross-sectional relationships between lifestyle and reproductive factors and these markers among controls (n = 1910) from a nested case-control study in the European Prospective Investigation into Cancer and Nutrition (EPIC). Improvements in discrimination of prediction models adjusting for correlates of the markers were evaluated among postmenopausal women in the nested case-control study (n = 590 cases). Generalized linear models were used to calculate geometric means of CA125, CA15.3, and HE4. CA72.4 above vs. below limit of detection was evaluated using logistic regression. Early detection prediction was modeled using conditional logistic regression.ResultsCA125 concentrations were lower, and CA15.3 higher, in post- vs. premenopausal women (p ≤ 0.02). Among postmenopausal women, CA125 was higher among women with higher parity and older age at menopause (ptrend ≤ 0.02), but lower among women reporting oophorectomy, hysterectomy, ever use of estrogen-only hormone therapy, or current smoking (p < 0.01). CA15.3 concentrations were higher among heavier women and in former smokers (p ≤ 0.03). HE4 was higher with older age at blood collection and in current smokers, and inversely associated with OC use duration, parity, and older age at menopause (≤ 0.02). No associations were observed with CA72.4. Adjusting for correlates of the markers in prediction models did not improve the discrimination.ConclusionsThis study provides insights into sources of variation in ovarian cancer early detection markers in healthy women and informs about the utility of individualizing marker cutpoints based on epidemiologic factors.Electronic supplementary materialThe online version of this article (doi:10.1186/s13048-017-0315-6) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 93%

Correlates of circulating ovarian cancer early detection markers and their contribution to discrimination of early detection models: results from the EPIC cohort

et al. 2017

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“…The sensitivity and specificity of HE4 were 0.359 and 0.951, respectively, in patients under the age of 50 and 0.718 and 0.952 in subjects 50 years or older. In addition, the sensitivity and specificity of ROMA were 0.391 and 0.961, respectively, in premenopausal women and 0.845 and 0.800 in postmenopausal patients . Although the specificity in a certain group was high, the sensitivity was lower than 0.4; therefore, this makes it difficult to apply normal cutoff values in actual clinical situations.…”

Section: Discussionmentioning

confidence: 99%

“…In Korea, the HE4 test has been utilized as a new biomarker for ovarian cancers since 2014. Although many studies have been conducted regarding the diagnostic performance of HE4, CA 125, and ROMA in different countries and races, there is little research on the utility of HE4 and ROMA in Korean women . Therefore, it is necessary to investigate the clinical utility of HE4 and CA 125 and to identify the optimal ROMA cutoff for the diagnosis of ovarian cancer in Koreans.…”

Section: Introductionmentioning

confidence: 99%

Diagnostic performance of CA 125, HE4, and risk of Ovarian Malignancy Algorithm for ovarian cancer

Kim

Park

Kim

et al. 2018

Clinical Laboratory Analysis

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“…Most cases showed lower level of HE4 than the cut-off value by manufacturer's guideline. HE4 level is known to be affected by ethnicity, and Asian populations had a wide reference range of HE4 [1328]. In Korean women, a new cut-off level of HE4 was suggested to differentiate ovarian cancer from benign lesion.…”

Section: Discussionmentioning

confidence: 99%

“…There were few studies that evaluated the effect of menopause on ROMA, although ROMA was induced from two different calculations according to menopausal status [10]. In Korea, ROMA is commonly used to detect ovarian malignancy without definite guidelines for general population [13]. Therefore, we designed this study to evaluate the discrimination power of ROMA compared with CA 125 or HE4 in Korean women.…”

Section: Introductionmentioning

confidence: 99%

The power of the Risk of Ovarian Malignancy Algorithm considering menopausal status: a comparison with CA 125 and HE4

et al. 2019

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ObjectiveTo identify the power of tumor markers for predicting ovarian cancer according to menopausal status.MethodsThe medical records of 876 women with ovarian cysts were retrospectively reviewed. Cancer antigen 125 (CA 125), human epididymis protein 4 (HE4), and Risk of Ovarian Malignancy Algorithm (ROMA) were analyzed. Sensitivity, specificity, and the receiver operating characteristic (ROC) curve analyses of these tumor markers were evaluated.ResultsThe sensitivity of ROMA was 66.7% and the specificity was 86.8% to detect ovarian malignancy. The patients were divided into 2 groups according to menopausal status: premenopause (n=532, 60.7%) and postmenopause (n=344, 39.3%). For diagnostic accuracy, ROMA was lower than HE4 in premenopausal women (82.7% vs. 91.4%) and lower than CA 125 in postmenopausal women (86.9% vs. 88.7%). The ROC curve analysis revealed that the power of ROMA was not significantly better than that of HE4 in premenopausal women (area under the curve [AUC], 0.731 vs. 0.732, p=0.832), and it was also not significantly better than that of CA 125 in postmenopausal women (AUC, 0.871 vs. 0.888, p=0.440).ConclusionThe discrimination power of tumor markers for ovarian cancer was different according to menopausal status. In predicting ovarian malignancy, ROMA was neither superior to HE4 in premenopausal women nor superior to CA 125 in postmenopausal women.

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Diagnostic performance and establishment of reference limits of HE4 in Korean healthy women

Cited by 6 publications

References 37 publications

Correlates of circulating ovarian cancer early detection markers and their contribution to discrimination of early detection models: results from the EPIC cohort

Correlates of circulating ovarian cancer early detection markers and their contribution to discrimination of early detection models: results from the EPIC cohort

Diagnostic performance of CA 125, HE4, and risk of Ovarian Malignancy Algorithm for ovarian cancer

The power of the Risk of Ovarian Malignancy Algorithm considering menopausal status: a comparison with CA 125 and HE4

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