Àrea da Mulher e da Reprodução, Hospital de Dona Estefânia, Centro Hospitalar de Lisboa Central
Problem Statement: Ovarian cancer (OC) is the fifth commonest cause of cancer-related deaths among women worldwide and accounts for 4% of all cancer deaths in women. Death from OC is strongly related to disease stage: survival rates in stages 1 and 3 are more than 70% and in stages 3 and 4 range from 0% to 20%. Early detection has great promise to improve clinical outcome, however, OC presents several diagnostic challenges and the difficulty differentiating between benign and malignant adnexal masses results in many surgical procedures for masses that are ultimately determined to be benign. Diagnosis is based on clinical findings, ultrasound and serum biomarkers. Currently, no serum biomarker is both highly sensitive and specific for the diagnosis; emphasis is now in combined serum markers or used multimodality strategies to improve the detection of malignancy. ROMA, the Risk of Malignancy Algorithm, is quantitative serum test that combines HE4, CA 125 and menopausal status into a numerical score, classifying patients with pelvic masses as being at low risk or high risk for malignant disease. It was approved by the FDA in 2011 to further assess the likelihood of malignancy in women who are planning to have surgery for an adnexal mass.This study aim is to evaluate the performance of the predictive model ROMA to assess the risk of OC in women with a pelvic mass.
Methods: Retrospective study from 01.2012 to 05.2013 including all patients assessed for their expression of the tumor markers CA125, HE4 and ROMA after been diagnosed with ovarian masses through imaging. ROMA was then correlated with the histological result.
Results:76 women with ovarian mass and ROMA determination, 27 (36%) premenopausal and 49 (64%) postmenopausal. In the premenopausal group, 5 women (5/27; 19%) had positive (≥13,1) ROMA and 22 women (22/27; 81%) had negative ROMA (< 13,1). Median women age is 42 years (min. 27, max. 51). Positive ROMA values range from 16,3 to 67. In these ROMA positive women, only one Ca 125 was positive (134).All ROMA positive women went surgery; no malignant histology results were detected (0/5; 0%).False-positive rate: 5/5 (100%). In the postmenopausal group, 8 women (8/49; 16%) had positive ROMA (≥ 27,7) and 41 women (41/49; 84%) had negative ROMA (< 27,7).Median women age is 64 years (min. 51, max. 83). Positive ROMA values range from 28,4 to 94.Threepositive ROMA women went surgery;the remaining five continue medical follow-up. All women submitted to surgery had negative Ca 125. Histological results were: metastasis from brest cancer (1 case); mucinous cistadenoma (1 case);serous and inclusion cists(1 case). False-positive rate: 2/3 (67%).
Conclusion:A2012 meta-analysis (Li F. et all, BMC Cancer, 2012) of 11 studies of women with a pelvic mass concluded that for diagnosis of early stage OC in premenopausal women,ROMA sensitivity and specificity were 82%; for postmenopausal women sensitivity was 93% and specificity was 79%. Our results are not consistent with these data; one possible explanation is the reduced number of cases included in the study, however, additional validation of ROMA seems necessary.