Physiopathological factors affecting the diagnostic value of serum HE4-test for gynecologic malignancies

Qu, Wanglei; Li, Jinping; Duan, Peng; Tang, Zuoqing; Guo, Feng-Biao; Chen, Haibin; Zhu, Xueqiong; Jiang, Shi‐Wen

doi:10.1080/14737159.2016.1251317

Cited by 21 publications

(16 citation statements)

References 94 publications

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“…There was also no significant difference in age or BMI in responders compared to non-responders, minimising confounding bias. Although a previous study reported levels of serum HE4 29% higher in smokers compared to non-smokers [30,33] in healthy patients, in the current study serum HE4 trended higher in smokers but did not reach statistical significance, probably due to only~10% of patients in this study being smokers. Limitations of the study were the small sample size and smaller proportion of non-responders compared to responders available for comparison.…”

Section: Discussioncontrasting

confidence: 99%

“…In addition, 68% of AH/Stage Ia EEC patients responded to the LNG-IUS by 12 months, with AH showing a higher response rate compared to Stage I EEC, similar to previous studies [7][8][9][10][11] supporting that the sample is representative of the background patient population. Baseline serum HE4 was also positively associated with patient age, BMI, menopause, in agreement with previous studies [17,18,[22][23][24]30,31]. Baseline serum HE4 was also significantly higher in G1EEC compared to AH, in support of previous studies [21,22,32].…”

Section: Discussionsupporting

confidence: 91%

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Baseline Serum HE4 But Not Tissue HE4 Expression Predicts Response to the Levonorgestrel-Releasing Intrauterine System in Atypical Hyperplasia and Early Stage Endometrial Cancer

Behrouzi

Ryan

Barr

et al. 2020

Cancers

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The levonorgestrel-releasing intrauterine system (LNG-IUS) is a conservative management option for atypical hyperplasia (AH) and low grade early stage endometrial cancer (EEC), but around 1 in 3 patients fail to respond to treatment. The aim of this study was to investigate if serum and/or tissue HE4 expression could predict response to LNG-IUS therapy. Patients with AH or presumed Stage I EEC had serum and endometrial samples taken at baseline and at 3-month intervals over 12 months post-insertion of LNG-IUS. 74 patients were recruited and baseline demographics recorded. Of 57 patients for whom response was histologically determinable, 39 (68%) were responders and 18 (32%) non-responders. Mean baseline serum HE4 was significantly lower in responders (62.1 ± 1.1 pM, 95% confidence interval (CI) 52.7–73.2), compared to non-responders (125.6 ± 1.3 pM, 95% CI 74.5–211.7, p = 0.014), including when considering age, BMI, menopausal status, smoking status, and histological grade as covariables (p = 0.005). Baseline tissue HE4 expression was not significantly different in responders compared to non-responders (p = 0.999). Responders showed a significant mean reduction (−9.8 ± 3.4%, 95% CI −16.7 to −2.8%, p = 0.008) in serum HE4 between baseline and 3 months (p = 0.008), whereas non-responders showed no significant change (p = 0.676). Neither responders nor non-responders showed a significant percentage change in serum HE4 from baseline beyond 3 months (p > 0.05). Change in serum HE4 between baseline and 3 and 6 months and tissue HE4 tissue expression between baseline and 3, 6, and 12 months was not significantly different in responders compared to non-responders (p > 0.05). This study suggests that baseline serum HE4, but not baseline tissue HE4 expression, is independently predictive of response to the LNG-IUS and could be used to guide management decisions.

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Section: Discussioncontrasting

confidence: 99%

Section: Discussionsupporting

confidence: 91%

Baseline Serum HE4 But Not Tissue HE4 Expression Predicts Response to the Levonorgestrel-Releasing Intrauterine System in Atypical Hyperplasia and Early Stage Endometrial Cancer

Behrouzi

Ryan

Barr

et al. 2020

Cancers

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“…In particular, only 15.5% of our patients were diagnosed at advanced stage. The discrepancy may also be attributable to other variables which may influence HE4 concentration, such as renal function, hormonal levels, age, later menarche, or smoke …”

Section: Discussionmentioning

confidence: 99%

The clinical significance of DJ‐1 and HE4 in patients with endometrial cancer

Benati

Montagnana

Danese

et al. 2017

Clinical Laboratory Analysis

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Background The non‐invasive diagnostic approach for early detection of endometrial cancer (EC) remains limited. To date, human epididymis protein 4 (HE4) has been intensively studied but its diagnostic is controversial in EC. DJ‐1 is an oncoprotein secreted by cancer cells, recently identified as a potential diagnostic biomarker for breast cancer, melanoma, and pancreatic cancer. The aim of this study was to compare the diagnostic performances of DJ‐1 and HE4 measured in EC patients and healthy controls (HC). Methods Forty‐five patients (63.9±12.0 years) with EC and 29 (63.2±13.3 years) HC were enrolled. Serum concentrations of DJ‐1 and HE4 were measured using ELISA kits developed by R&D (Minneapolis, USA) and Fujirebio Diagnostic (Malvern, PA, USA), respectively. Differences between EC patients and HC were assessed by Mann‐Whitney test and associations were tested by Spearman's correlation. The diagnostic performance was assessed using receiver operating characteristics (ROC) curves analysis. Results Serum DJ‐1 concentrations were found to be higher in EC patients than in HC (9533.6 vs 1988.5 pg/mL; P<.0001). The area under the ROC curve (ROC‐AUC) was 0.95 (P<.0001). At the cut‐off of 3654 pg/mL, the sensitivity and specificity were 0.89 and 0.90, respectively. HE4 serum levels were higher in EC patients than in HC (75.3 vs 56.2 pmol/L; P=.019), with an AUC of 0.66 (P=.020). The AUC obtained by the combination of the two markers resulted 0.96 (P<.0001). Conclusion These results suggest that increased serum DJ‐1 levels are associated with EC and that this biomarker may be potentially useful for diagnosing EC.

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“…The use of a universal equation for the calculation of ovarian malignancy risk is questionable. HE4 values can hardly be interpreted without the knowledge of age, menstrual status, serum creatinine, organ complications, hormonal therapy and other medication, smoking status, body mass index and possibly other, yet unidentified, factors . Several ongoing prospective randomised trials evaluate the diagnostic and prognostic roles of HE4 in gynecological malignancies and other conditions .…”

Section: Discussionmentioning

confidence: 99%

“…HE4 values can hardly be interpreted without the knowledge of age, menstrual status, serum creatinine, organ complications, hormonal therapy and other medication, smoking status, body mass index and possibly other, yet unidentified, factors. 10,11,28 Several ongoing prospective randomised trials evaluate the diagnostic and prognostic roles of HE4 in gynecological malignancies and other conditions. 29 However, the prognostic potential of HE4 can be diminished by many confounding factors, while the data on diagnostic efficacy in patients after solid organ transplantation are scarce.…”

Section: Case-control Studymentioning

confidence: 99%

Falsely elevated human epididymis protein 4 results and Risk of Ovarian Malignancy Algorithm in polymorbid women after solid organ transplantation: A pilot and case‐control study

Franeková

Cindr

Lavríková

et al. 2018

Clinical Laboratory Analysis

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Physiopathological factors affecting the diagnostic value of serum HE4-test for gynecologic malignancies

Cited by 21 publications

References 94 publications

Baseline Serum HE4 But Not Tissue HE4 Expression Predicts Response to the Levonorgestrel-Releasing Intrauterine System in Atypical Hyperplasia and Early Stage Endometrial Cancer

Baseline Serum HE4 But Not Tissue HE4 Expression Predicts Response to the Levonorgestrel-Releasing Intrauterine System in Atypical Hyperplasia and Early Stage Endometrial Cancer

The clinical significance of DJ‐1 and HE4 in patients with endometrial cancer

Falsely elevated human epididymis protein 4 results and Risk of Ovarian Malignancy Algorithm in polymorbid women after solid organ transplantation: A pilot and case‐control study

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