title: HE4, CA125, the Risk of Malignancy Algorithm and the Risk of Malignancy Index and complex pelvic masses - a prospective comparison in the pre-operative evaluation of pelvic masses in an Australian population.
abstract: BACKGROUND
  Human epididymis protein 4 (HE4) has been proposed as a novel biomarker for the diagnosis of epithelial ovarian cancer. Using HE4 and CA125, the risk of malignancy algorithm (ROMA) has been shown to be effective in the stratification of epithelial ovarian cancer risk.
  
  
  OBJECTIVE
  To determine the effectiveness of HE4 and ROMA in the diagnosis of malignancy of women presenting with a complex pelvic mass in an Australian population and to compare it with CA125 and the risk of malignancy index (RMI).
  
  
  METHODS
  Prospective recruitment of women was conducted between October 2012 and March 2014 (n = 50). CA125 and HE4 serum concentrations were collected and stored for subsequent analysis. Sensitivities, specificities, positive predictive values (PPV) and negative predictive values (NPV) were calculated for HE4, CA125, ROMA and the RMI. Receiver operating characteristic (ROC) area under the curves (AUC) were also calculated for comparison.
  
  
  RESULTS
  There was a higher HE4 level in women with ovarian cancer compared with women with benign pathology (P = 0.008), and this observation was seen in benign versus stage 1 ovarian cancer women (P = 0.025). HE4 had a better specificity than CA125 for the diagnosis of ovarian cancer in all women (P = 0.022), and this effect was also observed in premenopausal women (P = 0.012). Furthermore, the ROC-AUC for HE4 was superior than CA125 in all women (P = 0.0451). The ROMA algorithm was not inferior to the RMI calculation in this population.
  
  
  CONCLUSIONS
  In an Australian population, HE4 and ROMA are useful in the diagnosis of epithelial ovarian cancer.
authors.affiliation: Lifehouse Gynaecology Oncology Group, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.|Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
authors.forename: Anthony
authors.initials: A
authors.lastname: Richards
authors.affiliation: Lifehouse Gynaecology Oncology Group, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.|Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
authors.forename: Unine
authors.initials: U
authors.lastname: Herbst
authors.affiliation: Lifehouse Gynaecology Oncology Group, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.|Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
authors.forename: Jane
authors.initials: J
authors.lastname: Manalang
authors.affiliation: Lifehouse Gynaecology Oncology Group, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.|Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.|Central Clinical School, University of Sydney, Camperdown, New South Wales, Australia.
authors.forename: Selvan
authors.initials: S
authors.lastname: Pather
authors.affiliation: Lifehouse Gynaecology Oncology Group, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.|Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.|Central Clinical School, University of Sydney, Camperdown, New South Wales, Australia.
authors.forename: Samir
authors.initials: S
authors.lastname: Saidi
authors.affiliation: Lifehouse Gynaecology Oncology Group, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.|Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.|Central Clinical School, University of Sydney, Camperdown, New South Wales, Australia.
authors.forename: Trevor
authors.initials: T
authors.lastname: Tejada-Berges
authors.affiliation: Endocrinology Laboratory, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
authors.forename: Kris
authors.initials: K
authors.lastname: Tan
authors.affiliation: Central Clinical School, University of Sydney, Camperdown, New South Wales, Australia.|Endocrinology Laboratory, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Williams
authors.affiliation: Lifehouse Gynaecology Oncology Group, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.|Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.|Central Clinical School, University of Sydney, Camperdown, New South Wales, Australia.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Carter
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D019540:Area Under Curve; D001315:Australia; D014408:Biomarkers, Tumor / Q000097:blood*; D018394:CA-125 Antigen / Q000378:metabolism*; D000077216:Carcinoma, Ovarian Epithelial; D015331:Cohort Studies; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000628:therapy; D009367:Neoplasm Staging; D009375:Neoplasms, Glandular and Epithelial / Q000097:blood / Q000401:mortality / Q000473:pathology / Q000601:surgery; D010051:Ovarian Neoplasms / Q000097:blood / Q000401:mortality* / Q000473:pathology* / Q000601:surgery*; D010052:Ovariectomy / Q000009:adverse effects / Q000379:methods; D010386:Pelvic Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery; D011300:Preoperative Care / Q000379:methods; D011379:Prognosis; D011446:Prospective Studies; D011506:Proteins / Q000378:metabolism*; D012372:ROC Curve; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome; D000081102:WAP Four-Disulfide Core Domain Protein 2
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; D011506:Proteins; D000081102:WAP Four-Disulfide Core Domain Protein 2; C569698:WFDC2 protein, human
keywords: CA125; HE4; ovarian cancer; risk of ovarian malignancy algorithm; risk of ovarian malignancy index