Originally published as JCO Early Release 10.1200/JCO.2006.09.5943 on August 13 2007

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Inclusion of CA-125 Does Not Improve Mathematical Models Developed to Distinguish Between Benign and Malignant Adnexal Tumors

Dirk Timmerman, Ben Van Calster, Davor Jurkovic, Lil Valentin, Antonia C. Testa, Jean-Pierre Bernard, Caroline Van Holsbeke, Sabine Van Huffel, Ignace Vergote, Tom Bourne

From the Department of Obstetrics and Gynecology, University Hospitals Katholieke Universiteit Leuven; Department of Electrical Engineering, ESAT-SISTA, Katholieke Universiteit Leuven, Belgium; Department of Obstetrics and Gynaecology, King's College Hospital; Department of Obstetrics and Gynaecology, St George's Hospital Medical School, University of London, London, United Kingdom; Department of Obstetrics and Gynaecology, Malmö University Hospital, Malmö, Sweden; Istituto di Clinica Ostetrica e Ginecologica, Università Cattolica del Sacro Cuore, Roma, Italy; and the Service Gyn/Obstétrique, Centre Médical des Pyramides, Maurepas, France

Address reprint requests to Dirk Timmerman, MD, PhD, Department of Obstetrics and Gynecology, University Hospitals, KU Leuven, Herestraat 49, B-3000 Leuven, Belgium; e-mail: dirk.timmerman{at}uz.kuleuven.ac.be

Purpose To test the value of serum CA-125 measurements alone or as part of a multimodal strategy to distinguish between malignant and benign ovarian tumors before surgery based on a large prospective multicenter study (International Ovarian Tumor Analysis).

Patients and Methods Patients with at least one persistent ovarian mass preoperatively underwent transvaginal ultrasonography using gray scale imaging to assess tumor morphology and color Doppler imaging to obtain indices of blood flow.

Results Data from 809 patients recruited from nine centers were included in the analysis; 567 patients (70%) had benign tumors and 242 (30%) had malignant tumors—of these 152 were primary invasive (62.8%), 52 were borderline malignant (21.5%), and 38 were metastatic (15.7%). A logistic regression model including CA-125 (M2) resulted in an area under the receiver operating characteristic curve (AUC) of 0.934 and did not outperform a published (M1) without serum CA-125 information (AUC, 0.936). Specifically designed new models including CA-125 for premenopausal women (M3) and for postmenopausal women (M4) did not perform significantly better than the model without CA-125 (M1; AUC, 0.891 v AUC, 0.911 and AUC, 0.975 v AUC, 0.949, respectively). In postmenopausal patients, serum CA-125 alone (AUC, 0.920) and the risk of malignancy index (AUC, 0.924) performed very well. Results were very similar when the models were prospectively tested on a group of 345 new patients with adnexal masses of whom 126 had malignant tumors (37%).

Conclusion Adding information on CA-125 to clinical information and ultrasound information does not improve discrimination of mathematical models between benign and malignant adnexal masses.

published online ahead of print at www.jco.org on August 13, 2007.

Supported by GOA-AMBioRICS, CoE EF/05/006, Belgian network DYSCO, BIOPATTERN (FP6-2002-IST 508803), ETUMOUR (FP6-2002-LIFESCIHEALTH 503094), by the Swedish Medical Research Council (Grants No. K98-17X-11605-03A, K2001-72X-11605-06A and K2002-72X-11605-07B), by Malmö University Hospital, the Malmö General Hospital Foundation for Fighting Against Cancer, and ALF-medel.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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