title: The utility of serum CA-125 in predicting extra-uterine disease in apparent early-stage endometrial cancer.
abstract: Surgical staging in early-stage uterine cancer is controversial. Preoperative serum CA-125 may be of clinical value in predicting the presence of extra-uterine disease in patients with apparent early-stage endometrial cancer. Between October 6, 2005, and June 17, 2010, 760 patients were enrolled in an international, multicentre, prospective randomized trial (LACE) comparing laparotomy with laparoscopy in the management of endometrial cancer apparently confined to the uterus. Of these, 657 patients with endometrial adenocarcinoma had a preoperative serum CA-125 value recorded. Multiple cross-validation analysis was undertaken to correlate preoperative serum CA-125 with stage of disease (Stage I vs. Stage II+) after surgery. Patients' median preoperative serum CA-125 was 14 U/ml. A cutoff point of 30 U/ml was associated with the smallest misclassification error, and using this cutoff, 98 patients (14.9%) had elevated CA-125 levels. Of those, 36 (36.7%) had evidence of extra-uterine disease. Of the 116 patients (17.7%) with evidence of extra-uterine disease, 31.0% had an elevated CA-125 level. On univariate and multivariable logistic regression analysis, only preoperative CA-125 level, but no other preoperative clinical characteristics were found to be associated with extra-uterine spread of disease. Utilizing a cutoff point of 30 U/ml achieved a sensitivity, specificity, positive predictive value and negative predictive value of 31.0, 88.5, 36.7 and 85.7%, respectively. Elevated CA-125 above 30 U/ml in patients with apparent early-stage disease is a risk factor for the presence of extra-uterine disease and may assist clinicians in the management of patients with clinical Stage I endometrial cancer.
authors.affiliation: Queensland Centre for Gynaecological Cancer, Brisbane, Australia.
authors.forename: James
authors.initials: J
authors.lastname: Nicklin
authors.forename: Monika
authors.initials: M
authors.lastname: Janda
authors.forename: Val
authors.initials: V
authors.lastname: Gebski
authors.forename: Thomas
authors.initials: T
authors.lastname: Jobling
authors.forename: Russell
authors.initials: R
authors.lastname: Land
authors.forename: Tom
authors.initials: T
authors.lastname: Manolitsas
authors.forename: Anthony
authors.initials: A
authors.lastname: McCartney
authors.forename: Marcelo
authors.initials: M
authors.lastname: Nascimento
authors.forename: Lewis
authors.initials: L
authors.lastname: Perrin
authors.forename: Jannah F
authors.initials: JF
authors.lastname: Baker
authors.forename: Andreas
authors.initials: A
authors.lastname: Obermair
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000097:blood*; D018394:CA-125 Antigen / Q000097:blood*; D005260:Female; D006801:Humans; D057230:Limit of Detection; D016015:Logistic Models; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000175:diagnosis*; D011446:Prospective Studies; D014594:Uterine Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen