Affiliation:
1. Department of Biochemistry, Guru Gobind Singh Medical College and Hospital, Baba Farid University of Health Sciences, Faridkot, Punjab, India
2. Department of Biochemistry, All India Institute of Medical Sciences, Bathinda, Punjab, India
3. Department of Gynaecology and Obstetrics, Guru Gobind Singh Medical College and Hospital, Baba Farid University of Health Sciences, Faridkot, Punjab, India
4. Department of Pathology, Guru Gobind Singh Medical College and Hospital, Baba Farid University of Health Sciences, Faridkot, Punjab, India
5. Department of Biochemistry, Dr. S.S. Tantia Medical College, Hospital and Research Centre, Sriganganagar, Rajasthan, India
Abstract
Abstract
Background Inadequacy of effective sensitive and specific screening modalities results in late-stage diagnosis of ovarian cancer. Cancer Antigen-125 (CA-125) individually possesses limited specificity for differentiating adnexal masses. The present study aimed to evaluate the Human Epididymis Protein 4 (HE4), Risk of Ovarian Malignancy Algorithm (ROMA), and Risk of Malignancy Index (RMI) for ameliorating sensitivity and specificity for differentiating benign from malignant adnexal masses.
Materials and Methods This study was conducted on 96 preoperative women with suspected adnexal mass (patients) and 48 healthy females without adnexal mass (controls) for the duration of 2 years. Both study participants were divided into two groups, pre- and postmenopausal. CA-125 and HE4 were done using commercially available kits. ROMA% and RMI were calculated. We validated their performances using histopathology as the gold standard. The statistical analysis was done using SPSS 21, Kruskal–Wallis, and Tukey's tests. The best cutoff points to best values of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were also evaluated.
Results For differentiating benign from malignant masses in the premenopausal group, the sensitivity, specificity, PPV, NPV, and area under the curve (AUC) were 93.7%, 78.3%, 65.2%, 96.6%, 0.892 for CA-125; 87.5%, 83.7%, 70%, 93.9%, 0.926 for HE4; 93.7%, 70.2%, 57.6%, 96.2%, 0.927 for ROMA; and 68.7%, 86.4%, 68.7%, 86.5%, 0.916 for RMI. While in the postmenopausal group, the sensitivity, specificity, PPV, NPV, and AUC were 92.3%, 76.4%, 85.7%, 86.6%, 0.907 for CA-125; 78.5%, 94%, 95.6%, 80%, 0.955 for HE4; 92.3%, 94.1%, 96%, 88.8%, 0.968 for ROMA; and 88.4%, 88.2%, 92%, 83.3%, 0.943 for RMI.
Conclusion For differentiating benign from malignant masses more specifically in women with a suspected adnexal mass, ROMA and HE4 appear to be more effective than CA-125.