The utility of serum CA-125 in predicting extra-uterine disease in apparent early-stage endometrial cancer
International Journal of Cancer, 04/23/2012  Clinical Article

Nicklin J et al. – Elevated CA–125 above 30U/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.

• 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 14U/ml.
• Utilizing a cutoff point of 30U/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 30U/ml achieved a sensitivity, specificity, positive predictive value and negative predictive value of 31.0, 88.5, 36.7 and 85.7%, respectively.