title: The role of novel biomarker HE4 in endometrial cancer: a case control prospective study.
abstract: The aim of the study was to explore the clinical value of serum human epididymis secretory protein E4 (HE4) and CA125 in endometrial carcinoma. From January 2010 to April 2012, serum specimens were collected from consecutive cases of endometrial carcinoma and from cases of uterus benign disease (control group). The CA125 normal value is considered less than 35 U/mL. Two HE4 cutoff are considered: less than 70 pmol/L and less than 150 pmol/L. The specificity analysis was performed using the Mann-Whitney test for the CA125 and HE4 series. The level of statistical significance is set at p < 0.05. The sensitivity of CA125 in detecting endometrial cancer is 19.8 %, whereas the sensitivity of HE4 is 59.4 and 35.6 % for 70 and 150 pmol/L cutoff, respectively. Thus the specificity of HE4 is 100 % (positive predictive value = 100 %, negative predictive value = 71.52 and 61.31 % considering the two HE4 cutoff, respectively), whereas the CA125 specificity is 62.14 % (positive predictive value = 33.9 %, negative predictive value = 44.14 %) in detection of endometrial cancer. Combining CA125 and HE4, the sensitivity to detect endometrial cancer is 60.4 and 34.6 %, at HE4 cutoff of 70 and 150 pmol/L, respectively, with a specificity of 100 %. HE4 may be a new tool for preoperative evaluation and postoperative surveillance of endometrial cancer patients, with a positive predictive value = 100 %. HE4 at cutoff of 70 pmol/L yields the best sensitivity and specificity.
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Via Alvaro del Portillo, 200-00128, Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Angioli
authors.forename: Francesco
authors.initials: F
authors.lastname: Plotti
authors.forename: Stella
authors.initials: S
authors.lastname: Capriglione
authors.forename: Roberto
authors.initials: R
authors.lastname: Montera
authors.forename: Patrizio
authors.initials: P
authors.lastname: Damiani
authors.forename: Roberto
authors.initials: R
authors.lastname: Ricciardi
authors.forename: Alessia
authors.initials: A
authors.lastname: Aloisi
authors.forename: Daniela
authors.initials: D
authors.lastname: Luvero
authors.forename: Ester Valentina
authors.initials: EV
authors.lastname: Cafà
authors.forename: Nella
authors.initials: N
authors.lastname: Dugo
authors.forename: Michela
authors.initials: M
authors.lastname: Angelucci
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Benedetti-Panici
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000032:analysis / Q000097:blood; D018394:CA-125 Antigen / Q000097:blood*; D016022:Case-Control Studies; D016889:Endometrial Neoplasms / Q000097:blood* / Q000175:diagnosis* / Q000378:metabolism; D030501:Epididymal Secretory Proteins / Q000032:analysis; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology; D008565:Membrane Proteins / Q000097:blood*; D008875:Middle Aged; D011446:Prospective Studies; D011506:Proteins / Q000032:analysis*; D000081102:WAP Four-Disulfide Core Domain Protein 2
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; D030501:Epididymal Secretory Proteins; C451759:MUC16 protein, human; D008565:Membrane Proteins; D011506:Proteins; D000081102:WAP Four-Disulfide Core Domain Protein 2; C569698:WFDC2 protein, human