Ovarian Malignancy Risk (ROMA®)

Ovarian cancer is the fourth most common cause of cancer- related death in women worldwide. In 2014, in the United States, 21,290 women were diagnosed with ovarian cancer and 14,180 died of it.¹ The symptoms of ovarian cancer are related to the presence of adnexal masses and are often vague and unspecific. The primary goal of diagnostic evaluation of an adnexal mass is to determine whether it is benign or malignant. It is estimated that 5% to 10% of women in the United States will undergo a surgical procedure for a suspected ovarian neoplasm during their lifetime, and 13% to 21% of these women will be found to have an ovarian malignancy.² The American College of Obstetricians and Gynecologists Practice Bulletin 174 published in 2016 states that consultation with or referral to a gynecologic oncologist is recommended for women (both premenopausal or postmenopausal) with an adnexal mass who have an elevated score on a formal risk assessment tests such as the ROMA.³ Since the majority of adnexal masses are benign, it is important to determine preoperatively whether a patient is at high likelihood for ovarian malignancy, in order to ensure proper management.

The ROMA value is used to stratify women into likelihood groups for finding cancer on surgery. To improve the management of patients presenting with adnexal mass, the results of the ROMA may be used in conjunction with Initial Cancer Risk Assessment (ICRA) in assessing the likelihood of finding malignancy on surgery in premenopausal and postmenopausal women presenting with an adnexal mass. Several studies looked at the sensitivity of the ROMA at predefined specificity for identifying ovarian cancer and found that the use of ROMA increases sensitivity compared with CA 125 or HE4 alone.^4-7 Moore et al. did a prospective, multi-center trial evaluating women with a pelvic mass who had an initial clinical risk assessment (ICRA) performed by a generalist. Adjunctive use of ROMA with ICRA improved the stratification of these women into low and high risk groups for ovarian cancer. The combination was particularly effective in ruling out malignant disease.⁸ In order to provide a specificity level of 75%, a cut- off point of greater than or equal to 1.14 was used for premenopausal and greater than of equeal to 2.99 was used for postmenopausal women who present with an ovarian adnexal mass.⁹ Women with ROMA results that are equal to or above these cut-off points are at high likelihood of finding malignancy on surgery.

Use of ROMA for stratification into low and high likelihood groups for finding malignancy on surgery

Using preoperatively collected serum samples, ROMA value were determined and the patients were stratified into a low or high likelihood group for finding malignancy on surgery.⁹ Samples were tested at three US testing sites. The following cut-off points were used in order to provide a specificity level of 75%:

Premenopausal women:

• ROMA score ≥1.14: high likelihood of finding malignancy

• ROMA score <1.14: low likelihood of finding malignancy

Postmenopausal women:

• ROMA score ≥2.99: high likelihood of finding malignancy

• ROMA score <2.99: low likelihood of finding malignancy

The reported results include both the likelihoods and associated ROMA scores for premenopausal and postmenopausal women on a scale of 0-10.

1. Siegel RL, Miller KD, Jemal A. Cancer statistics. CA Cancer J. Clin. 2015 Jan-Feb;65(1):5-29. PubMed 25559415

2. National Institutes of Health Consensus Development Conference Statement. Ovarian cancer: Screening, treatment and follow-up. Gynecol Oncol. 1994 Dec; 55(3 Pt 2):S4-14. PubMed 7835809

3. Practice Bulletin No. 174 Summary: Evaluation and Management of Adnexal Masses. Obstet Gynecol. 2016;128(5):1193-1195. PubMed 27776067

4. Kadija S, Stafanovic A, Jeremic K, et al. The utility of human epididymal protein 4, cancer antigen 125, and risk for malignancy algorithm in ovarian cancer and endometriosis. Int J Gynecol Cancer. 2012 Feb;22(2):238-244. PubMed 22214964

5. Moore RG, Miller MC, Disilvestro P, et al. Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass. Obstet Gynecol. 2011 Aug:280-288. PubMed 21775843

6. Fujiwara H, Suzuki M, Takeshima N, et al. Evaluation of human epididymis protein 4 (HE4) and Risk of Ovarian Malignancy Algorithm (ROMA) as diagnostic tools of type 1 and type II epithelial ovarian cancer in Japanese women. Tumour Biol. 2015 Feb;36(2):1045-1053. PubMed 25326813

7. Moore RG, McMeekin SD, Brown AK, et al. A novel multiple marker bio-assay utilizing HE4 and CA 125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2009;112:40-46. PubMed 18851871

8. Moore RG, Hawkins DM, Miller