Comparison of the predictive performance of risk of malignancy indexes 1–4, HE4 and risk of malignancy algorithm in the triage of adnexal masses

Abstract

Objectives: For patients presenting with adnexal mass, it is important to correctly distinguish whether the mass is benign or malignant for the purpose of precise and timely referral and implication of correct line of management. The objective of this study was to evaluate the performance of Risk of malignancy Indexes (RMI) 1-4, Human Epididymis Protein 4 (HE4) and Risk of Malignancy Algorithm (ROMA) in differentiating the adnexal mass into benign and malignant. Methods: A retrospective study using 155 patients diagnosed with adnexal mass between January 2014 to December 2014 in The First Affiliated Hospital of Zhengzhou University was conducted. The patient records were assessed for age, menopausal status, serum CA125 and HE4 levels, ultrasound characteristics of the pelvic mass and the final pathological diagnosis of the mass. RMI1, RMI2, RMI3, RMI4, ROMA were calculated for each patient and the sensitivity, specificity and the Receiver Operating Characteristics (ROC) curves were determined for each test to evaluate their performance. Results: Among 155 patients with adnexal masses meeting inclusion criteria, 120 (77.4%) were benign, 8 (5.2%) borderline and 27 (17.4%) were malignant. RMI2 and RMI4 had the highest sensitivity (66.7%) while HE4 had the highest specificity (96.9%).Although ROMA had the highest area under the curve (AUC) of 0.886 it was not found to be statistically superior to the other tests. For epithelial ovarian cancers, ROMA (80%), HE4 (96.9%) and RMI 4 (0.868) had the highest sensitivity, specificity and AUC respectively however, the AUC characteristics were not statistically significant between any groups. Compared to the postmenopausal group (sensitivity 72.2-77.8%) all the tests showed lower sensitivity (42.9%) for the premenopausal group of patients. Conclusions: RMI 1-4, ROMA and HE4 were all found to be useful for differentiating benign/borderline adnexal masses from malignant ones for deciding optimal therapy, however no test was found to be significantly better than the other. None were able to differentiate between benign and borderline tumors. All of the tests demonstrated increased sensitivity when borderline tumors were considered low-risk, and when only epithelial ovarian cancers were considered.

ESGO/ISUOG/IOTA/ESGE Consensus Statement on preoperative diagnosis of ovarian tumors

“…Many studies have demonstrated the diagnostic performance of the RMI in classifying adnexal masses 11,17–29 . Three variants of the RMI (RMI‐II, RMI‐III, RMI‐IV) have been developed, but these offer no significant additional diagnostic advantage compared with the original version (RMI‐I) 11,22,27,28 . Moore et al 30 .…”

“…These include the risk of malignancy index (RMI), a scoring system based on menopausal status, a transvaginal ultrasound score and serum cancer antigen 125 (CA 125) level 16 . Many studies have demonstrated the diagnostic performance of the RMI in classifying adnexal masses 11,[17][18][19][20][21][22][23][24][25][26][27][28][29] . Three variants of the RMI (RMI-II, RMI-III, RMI-IV) have been developed, but these offer no significant additional diagnostic advantage compared with the original version (RMI-I) 11,22,27,28 .…”

“…Many studies have demonstrated the diagnostic performance of the RMI in classifying adnexal masses 11,[17][18][19][20][21][22][23][24][25][26][27][28][29] . Three variants of the RMI (RMI-II, RMI-III, RMI-IV) have been developed, but these offer no significant additional diagnostic advantage compared with the original version (RMI-I) 11,22,27,28 . Moore et al 30 developed an algorithm, the risk of ovarian malignancy algorithm (ROMA), based on both CA 125 and human epididymis protein 4 (HE4).…”

ESGO/ISUOG/IOTA/ESGE Consensus Statement on preoperative diagnosis of ovarian tumours

“…These include the risk of malignancy index (RMI), a scoring system based on menopausal status, a transvaginal ultrasound score and serum cancer antigen 125 (CA 125) level (Jacobs et al, 1990 RMI in classifying adnexal masses (Akturk et al, 2011;Al-Musalhi et al, 2015;Al Musalhi et al, 2016;Anton et al, 2012;Bouzari et al, 2011;Chacon et al, 2019;Chopra et al, 2015;Dochez et al, 2019;Hada et al, 2020;Javdekar & Maitra, 2015;Khoiwal et al, 2019;Meys et al, 2016;Westwood et al, 2018;Zhang et al, 2019). Three variants of the RMI (RMI-II, RMI-III, RMI-IV) have been developed, but these offer no significant additional diagnostic advantage compared with the original version (RMI-I) (Akturk et al, 2011;Hada et al, 2020;Meys et al, 2016;Zhang et al, 2019). Moore et al (2008) developed an algorithm, the risk of ovarian malignancy algorithm (ROMA), based on both CA 125 and human epididymis protein 4 (HE4).…”

Using HE4, RMI, ROMA and CPH-I in the differential diagnosis of adnexal masses

“…It is difficult preoperatively distinguish between ovarian benign and borderline tumors and there are only a couple of studies regarding the evaluation of the effectiveness of different methods that have been reported. Hada et al compared the diagnostic performance of HE4, RMI and ROMA, in which none of the parameters was the ability to differentiate between benign and borderline tumors [16]. CPH-I was also evaluated but showed poor performance in discrimination of benign and borderline ovarian masses (AUC < 0.7) [17].…”