The ROMA (Risk of Ovarian Malignancy Algorithm) for estimating the risk of epithelial ovarian cancer in women presenting with pelvic mass: is it really useful?

Abstract

The ROMA is a simple scoring system which shows excellent diagnostic performance for the detection of EOC in post-menopausal women, but not in pre-menopausal women. Moreover, the dual marker combination of HE4 and CA125 (ROMA) does not show better performance than HE4 alone.

Tissue CA125 and HE4 Gene Expression Levels Offer Superior Accuracy in Discriminating Benign from Malignant Pelvic Masses

“…They suggested that ROMA was less specific but more sensitive than HE4, while both ROMA and HE4 were more specific than CA125 for EOC prediction. On contrary, a previous report (Montagnana et al, 2011) has demonstrated that ROMA did not show better diagnostic performance than HE4 alone in the diagnosis of ovarian cancer. Additionally, in another study (Van Gorp et al, 2011), it has been reported that combining HE4 and CA125 in the ROMA improved HE4 but not CA125 performance, indicating that ROMA and HE4 did not perform significantly better than CA125 alone.…”

“…There may be several explanations for the heterogeneity observed among previous studies, and in our opinion, the most intriguing are the differences in the study design, study population, demographic characteristics of patients, ovarian cancer prevalence, sample size, control group (healthy women or women with benign diseases), methods of measuring serum CA125 or HE4 levels (ELISA or chemiluminescent microparticle immunoassay) and cutoff values of CA125/HE4 assays (manufacturer or clinical practice). Furthermore, several studies did not take into account the effect of the uneven distribution of patients in pre-and post-menopausal status, histological subtypes and FIGO stages when interpreting the results of CA125 and HE4 measurements (Moore et al, 2009;Moore et al, 2010;Kim et al, 2011;Montagnana et al, 2011;Ruggeri et al, 2011;Van Gorp et al, 2011). Overall, each of these points theoretically represent a source of heterogeneity among studies likely influencing the markers' diagnostic performances.…”

“…Although several studies have reported that ROMA yielded a better diagnostic accuracy than either marker alone (Moore et al, 2008;Moore et al, 2009;Bandiera et al, 2011;Molina et al, 2011;Moore et al, 2011;Li et al, 2012;Ortiz-Muñoz et al, 2014;Fujiwara et al, 2015), other studies failed to demonstrate its superiority over CA125 or HE4 alone for assessing the risk of ovarian cancer (Montagnana et al, 2011;Van Gorp et al, 2011;Wang et al, 2014).…”

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

“…This and other studies have shown that ROMA is able to deliver an improved accuracy over either mark alone. Montagnana et al reported that preoperative ROMA calculation performed better than CA125, but no advantage could be found when compared to HE4 alone [12]. The application of HE4 for the prognosis and prediction of relapse for ovarian cancer patients has also been investigated.…”

“…Nassir et al reported that HE4 in combination with CA125 performed better than CA125 and HE4 alone in predicting relapse within 12 months after first-line chemotherapy [17]. Overall, HE4 has been demonstrated to be a more efficient marker for ovarian cancer than CA125, and it can be used either alone or as a part of ROMA in the differential diagnosis of pelvic masses and prediction of relapse for ovarian cancer patients after treatment [10,[12][13][14][15][16][17][18].…”