Comparison of a novel multiple marker assay vs the Risk of Malignancy Index for the prediction of epithelial ovarian cancer in patients with a pelvic mass.
OBJECTIVE
We sought to compare the Risk of Malignancy Index (RMI) to the Risk of Ovarian Malignancy Algorithm (ROMA) to predict epithelial ovarian cancer (EOC) in women with a pelvic mass.


METHODS
In all, 457 women with imaging results from ultrasound, computed tomography, magnetic resonance imaging, and serum HE4 and CA125 determined prior to surgery for pelvic mass were evaluable. RMI values were determined using CA125, imaging score, and menopausal status. ROMA values were determined using HE4, CA125, and menopausal status.


RESULTS
At a set specificity of 75%, ROMA had a sensitivity of 94.3% and RMI had a sensitivity of 84.6% for distinguishing benign status from EOC (P = .0029). In patients with stage I and II disease, ROMA achieved a sensitivity of 85.3% compared with 64.7% for RMI (P < .0001).


CONCLUSIONS
The dual marker algorithm utilizing HE4 and CA125 to calculate a ROMA value achieves a significantly higher sensitivity for identifying women with EOC than does RMI.
Moore
Richard G
RG
Program in Women's Oncology, Department of Obstetrics and Gynecology, Women & Infants Hospital of Rhode Island, Warren Alpert Medical School, Brown University, Providence, RI, USA. rmoore@wihri.org
Jabre-Raughley
Moune
M
Brown
Amy K
AK
Robison
Katina M
KM
Miller
M Craig
MC
Allard
W Jeffery
WJ
Kurman
Robert J
RJ
Bast
Robert C
RC
Skates
Steven J
SJ
D000465:Algorithms; D014408:Biomarkers, Tumor / Q000097:blood; D018394:CA-125 Antigen / Q000097:blood; D003952:Diagnostic Imaging; D030501:Epididymal Secretory Proteins / Q000032:analysis; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008565:Membrane Proteins / Q000097:blood; D008593:Menopause; D009367:Neoplasm Staging; D009375:Neoplasms, Glandular and Epithelial / Q000175:diagnosis*; D010051:Ovarian Neoplasms / Q000175:diagnosis*; D012372:ROC Curve; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D023083:beta-Defensins
D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; C426184:DEFB126 protein, human; D030501:Epididymal Secretory Proteins; C451759:MUC16 protein, human; D008565:Membrane Proteins; D023083:beta-Defensins
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