title: Comparison of HE4, CA125 and ROMA algorithm in women with a pelvic mass: correlation with pathological outcome.
abstract: OBJECTIVE
  The quality of first surgery is one of the most important prognostic factors in ovarian cancer patients. Pre-surgical distinction of benign and malignant pelvic mass plays a critical role in ovarian cancer management and survival. The aim of this study was to evaluate the clinical performance of ROMA algorithm and of CA125 and HE4 in the triage of patients with a pelvic mass undergoing surgery, in order to discriminate benign from malignant disease.
  
  
  METHODS
  Three hundred and forty-nine pre- and post-menopausal women, aged 18 years or older undergoing surgery because of a pelvic mass were enrolled: serum concentrations of CA125 and HE4 were determined and ROMA was calculated for each sample.
  
  
  RESULTS
  Median serum CA125 and HE4 levels were higher in patients with EOC compared to subjects with benign disease (p<0.0001). The resultant accuracy (using Receiver Operating Characteristics, ROC Area) values for HE4, CA125 and ROMA showed a good performance ranging from 89.8% for CA125 in pre-menopausal patients to 93.3% for ROMA in post-menopausal patients: AUC for ROMA resulted significantly higher in comparison to CA125 alone (93.3% vs 90.3%, p=0.0018) in post menopausal patients. A sub-analysis considering the 40 patients with endometrioid disease showed the highest accuracy of HE4 in these patients.
  
  
  CONCLUSIONS
  Data presented confirm the accuracy of HE4 and of the ROMA algorithm in the distinction of ovarian carcinoma from benign disease, with a trend towards better performance for ROMA than for CA125 alone, statistically significant in postmenopausal patients.
authors.affiliation: Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy. maria.sandri@ieo.it
authors.forename: M T
authors.initials: MT
authors.lastname: Sandri
authors.forename: F
authors.initials: F
authors.lastname: Bottari
authors.forename: D
authors.initials: D
authors.lastname: Franchi
authors.forename: S
authors.initials: S
authors.lastname: Boveri
authors.forename: M
authors.initials: M
authors.lastname: Candiani
authors.forename: S
authors.initials: S
authors.lastname: Ronzoni
authors.forename: M
authors.initials: M
authors.lastname: Peiretti
authors.forename: D
authors.initials: D
authors.lastname: Radice
authors.forename: R
authors.initials: R
authors.lastname: Passerini
authors.forename: M
authors.initials: M
authors.lastname: Sideri
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D014408:Biomarkers, Tumor / Q000097:blood; D018394:CA-125 Antigen / Q000097:blood*; D000077216:Carcinoma, Ovarian Epithelial; D003661:Decision Support Techniques; D003937:Diagnosis, Differential; D005260:Female; D006801:Humans; D008565:Membrane Proteins / Q000097:blood*; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000097:blood / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D010049:Ovarian Diseases / Q000097:blood / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D010051:Ovarian Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D010388:Pelvis / Q000473:pathology / Q000601:surgery; D017698:Postmenopause / Q000097:blood; D011446:Prospective Studies; D011506:Proteins / Q000378:metabolism*; D012372:ROC Curve; D000081102:WAP Four-Disulfide Core Domain Protein 2; D055815:Young Adult
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; C451759:MUC16 protein, human; D008565:Membrane Proteins; D011506:Proteins; D000081102:WAP Four-Disulfide Core Domain Protein 2; C569698:WFDC2 protein, human