Efficacy of HE4, CA125, Risk of Malignancy Index and Risk of Ovarian Malignancy Index to Detect Ovarian Cancer in Women with Presumed Benign Ovarian Tumours: A Prospective, Multicentre Trial

Vincent Dochez; Mélanie Randet; Céline Renaudeau; Jérôme Dimet; Aurélie Le Thuaut; Norbert Winer; Thibault Thubert; Edouard Vaucel; Hélène Caillon; Guillaume Ducarme

doi:10.3390/jcm8111784

journal article Open Access Oct 25, 2019

Efficacy of HE4, CA125, Risk of Malignancy Index and Risk of Ovarian Malignancy Index to Detect Ovarian Cancer in Women with Presumed Benign Ovarian Tumours: A Prospective, Multicentre Trial

Vincent Dochez

Mélanie Randet Céline Renaudeau Jérôme Dimet

Aurélie Le Thuaut Norbert Winer Thibault Thubert Edouard Vaucel Hélène Caillon Guillaume Ducarme

Journal of Clinical Medicine Vol. 8 No. 11 pp. 1784 · MDPI AG

View at Publisher Save 10.3390/jcm8111784

Abstract

Background: Presumed benign ovarian tumours (PBOT) are defined by the International Ovarian Tumour Analysis (IOTA) group, without suspected sonographic criteria of cancer, without ascites or metastasis. The aim is to evaluate the efficacy of human epididymis protein 4 (HE4), cancer antigen 125 (CA125), the risk of malignancy index (RMI) and the risk of ovarian malignancy index (ROMA) to predict ovarian cancer in women with PBOT. Methods: It is a prospective, observational, multicentre, laboratory-based study including women with PBOT in four hospitals from 11 May 2015 through 12 May 2016. Preoperative CA125 and HE4 plasma levels were measured for all women. The primary endpoint was the specificity of CA125 and HE4 for diagnosing ovarian cancer. The main secondary endpoints were specificity and likelihood ratio of RMI, ROMA and tumours markers. Results: Two hundred and fifty patients were initially enrolled and 221 patients were finally analysed, including 209 benign ovarian tumours (94.6%) and 12 malignant ovarian tumours (5.4%). The malignant group had significantly higher mean values of HE4, CA125, RMI and ROMA compared to the benign group (p < 0.001). Specificity was significantly higher using a combination of HE4 and CA125 (99.5%) compared to either HE4 or CA125 alone (90.4% and 91.4%, respectively, p < 0.001). Moreover, the positive likelihood ratio for combination HE4 and CA125 was significantly higher (104.5; 95% CI 13.6–800.0) compared to HE4 alone (5.81; 95% CI 2.83–11.90) or CA125 alone (6.97; 95% CI 3.91–12.41). Conclusions: The combination of HE4 and CA125 represents the best tool to predict the risk of ovarian cancer in patients with a PBOT.

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Details

Published: Oct 25, 2019
Vol/Issue: 8(11)
Pages: 1784
License: View

Authors

V

Vincent Dochez

Service de Gynécologie-Obstétrique, CHU de Nantes, 44093 Nantes, France

M

Mélanie Randet

Service de Gynécologie-Obstétrique, Centre Hospitalier de Saint-Nazaire, 44606 Saint-Nazaire, France

C

Céline Renaudeau

Service de Gynécologie-Obstétrique, Centre Hospitalier, 49325 Cholet, France

J

Jérôme Dimet

Centre de Recherche Clinique, Centre Hospitalier Départemental Vendée, 85925 La Roche sur Yon, France

A

Aurélie Le Thuaut

Centre de Recherche Clinique, Centre Hospitalier Départemental Vendée, 85925 La Roche sur Yon, France

N

Norbert Winer

Service de Gynécologie-Obstétrique, CHU de Nantes, 44093 Nantes, France

T

Thibault Thubert

Service de Gynécologie-Obstétrique, CHU de Nantes, 44093 Nantes, France

E

Edouard Vaucel

Service de Gynécologie-Obstétrique, CHU de Nantes, 44093 Nantes, France

H

Hélène Caillon

Service de Biochimie, CHU de Nantes, 44093 Nantes, France

G

Guillaume Ducarme

Service de Gynécologie-Obstétrique, Centre Hospitalier Départemental Vendée, 85925 La Roche sur Yon, France

Cite This Article

Vincent Dochez, Mélanie Randet, Céline Renaudeau, et al. (2019). Efficacy of HE4, CA125, Risk of Malignancy Index and Risk of Ovarian Malignancy Index to Detect Ovarian Cancer in Women with Presumed Benign Ovarian Tumours: A Prospective, Multicentre Trial. Journal of Clinical Medicine, 8(11), 1784. https://doi.org/10.3390/jcm8111784

Efficacy of HE4, CA125, Risk of Malignancy Index and Risk of Ovarian Malignancy Index to Detect Ovarian Cancer in Women with Presumed Benign Ovarian Tumours: A Prospective, Multicentre Trial

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