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Serum HE4 and diagnosis of ovarian cancer in postmenopausal women with adnexal masses

Gentry-Maharaj, A; Burnell, M; Dilley, J; Ryan, A; Karpinskyj, C; Gunu, R; Mallett, S; ... Menon, U; + view all (2020) Serum HE4 and diagnosis of ovarian cancer in postmenopausal women with adnexal masses. American Journal of Obstetrics and Gynecology , 222 (1) 56.e1-56.e17. 10.1016/j.ajog.2019.07.031. Green open access

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Abstract

Background Transvaginal ultrasound and serum CA125 are routinely used for differential diagnosis of pelvic adnexal mass. Use of Human Epididymis 4 (HE4) was approved in the United States in 2011. However, there is scarcity of studies evaluating the additional value of HE4. Objective To evaluate the performance characteristics of transvaginal ultrasound, CA125 and HE4 for differential diagnosis of ovarian cancer in postmenopausal women with adnexal masses. Study design Cohort study nested within the screen arms of the multicentre randomised controlled trial United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), based in England, Wales and Northern Ireland. In UKCTOCS, 48,230 women randomised to transvaginal ultrasound screening and 50,078 to multimodal screening (serum CA125 interpreted by Risk of Ovarian Cancer Algorithm with second line transvaginal ultrasound) underwent the first (prevalence) screen. Women with adnexal lesions and/or persistently elevated risk were clinically assessed and underwent surgery or follow-up for a median of 10.9 years. Banked samples taken within 6 months of transvaginal ultrasound from all clinically assessed women were assayed for HE4 and CA125. Area under the curve and sensitivity for diagnosing ovarian cancer of multiple penalized logistic regression models incorporating logCA125, logHE4, age and simple ultrasound features of the adnexal mass were compared. Results Of 1,590 (158 multimodal, 1432 ultrasound) women with adnexal masses, 78 were diagnosed with ovarian cancer (48 invasive epithelial ovarian - 14 Type I, 34 Type II; 24 borderline epithelial; 6 non-epithelial) within one-year of scan. The area under the curve (0.893 vs 0.896;p=0.453) and sensitivity (74.4%vs75.6%;p=0.564) at fixed specificity of 90% of the model incorporating age, ultrasound and CA125 was similar to that also including HE4. Both models had high sensitivity for invasive epithelial ovarian (89.6%) and Type II (>91%) cancers. Conclusions Our population cohort study suggests that HE4 adds little value to concurrent use of CA125 and transvaginal ultrasound in the differential diagnosis of adnexal masses in postmenopausal women.

Type: Article
Title: Serum HE4 and diagnosis of ovarian cancer in postmenopausal women with adnexal masses
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.ajog.2019.07.031
Publisher version: https://doi.org/10.1016/j.ajog.2019.07.031
Language: English
Additional information: © 2019 The Authors. This is anopen access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Keywords: Ovarian cancer, ovarian neoplasm, CA125, HE4, TVS, ultrasound, risk of malignancy diagnosis, adnexal mass, UKCTOCS
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Experimental and Translational Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health > Epidemiology and Public Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL EGA Institute for Womens Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL EGA Institute for Womens Health > Womens Cancer
URI: https://discovery.ucl.ac.uk/id/eprint/10078968
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