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Performance of ROMA based on Architect CA 125 II and HE4 values in Chinese women presenting with a pelvic mass: A
Fengxian Shen1, Shiming Lu1, Yibing Peng2
1Woman's Hospital, School of Medicine, Zhejiang University, Xueshi Road #2, Hangzhou 310006, China.
Background:
We evaluated the performance of human epididymis protein 4 (HE4), cancer antigen 125(CA 125) and Risk of Ovarian Malignancy Algorithm (ROMA) in distinguishing between benign and malignant pelvic masses in Chinese women.
Method:
From April to December 2012, women with a pelvic mass scheduled to have surgery were enrolled in a prospective, multi-center study conducted in 5 different regions in China. Preoperative serum concentrations of HE4 and CA 125 were examined and ROMA was calculated.
Results:
A total of 684 women with a pelvic mass were included, of which 482 were diagnosed with benign conditions and 202 were diagnosed with malignant ovarian tumors. At cutoffs of 7.4% and 25.3% for ROMA, the sensitivities and specificities were 85.6% and 81.7% for all patients, 85.7% and 81.5% for premenopausal women, and 85.6% and 83.9% for postmenopausal women, respectively. The ROC-AUC of ROMA was significantly better than that of HE4 (P=0.0003) or CA 125 (P<0.0001) for all malignant diseases (including EOC, Non-EOC, LMP, metastases and other pelvic malignancy with no involvement of the ovaries) compared with benign diseases for all patients.
Conclusions:
We demonstrated the efficiency of ROMA in the distinction of ovarian cancers from benign disease in a multiple-regions Chinese population, especially in premenopausal women.
