Journal of the National Cancer Institute Advance Access published online on November 13, 2007
JNCI Journal of the National Cancer Institute, doi:10.1093/jnci/djm199
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Discrimination Between Benign and Malignant Adnexal Masses by Specialist Ultrasound Examination Versus Serum CA-125
Affiliations of authors: Department of Electrical Engineering, ESAT-SISTA, Katholieke Universiteit Leuven, Belgium (BVC, SVH); Department of Obstetrics and Gynecology, University Hospitals, KU Leuven, Leuven, Belgium (DT, CVH, ED, PN); Department of Obstetrics and Gynaecology, St. George’s Hospital Medical School, University of London, London, U.K. (TB); Istituto di Clinica Ostetrica e Ginecologica, Università Cattolica del Sacro Cuore, Rome, Italy (ACT); Department of Obstetrics and Gynaecology, King's College Hospital, London, U.K. (DJ); Department of Obstetrics and Gynaecology, Malmö University Hospital, Lund University, Malmö, Sweden (LV)
Correspondence to: Dirk Timmerman, MD, PhD, Department of Obstetrics and Gynecology, University Hospitals, Katholieke Universiteit Leuven, Herestraat 49, B-3000 Leuven, Belgium (e-mail: dirk.timmerman{at}uz.kuleuven.ac.be).
Background: Subjective evaluation of gray-scale and Doppler ultrasound findings (i.e., pattern recognition) by an experienced examiner and preoperative serum levels of CA-125 can both discriminate benign from malignant adnexal (i.e., ovarian, paraovarian, or tubal) masses. We compared the diagnostic performance of these methods in a large multicenter study.
Methods: In a prospective multicenter study—the International Ovarian Tumor Analysis—1066 women with a persistent adnexal mass underwent transvaginal gray-scale and color Doppler ultrasound examinations by an experienced examiner within 120 days of surgery. Pattern recognition was used to classify a mass as benign or malignant. Of these women, 809 also had blood collected preoperatively for measurement of serum CA-125. Various levels of CA-125 were used as cutoffs to classify masses. Results from both assays were then compared with histologic findings after surgery.
Results: Pattern recognition correctly classified 93% (95% confidence interval [CI] = 90.9% to 94.6%) of the tumors as benign or malignant. Serum CA-125 correctly classified at best 83% (95% CI = 80.3% to 85.6%) of the masses. Histologic diagnoses that were most often misclassified by CA-125 were fibroma, endometrioma, and abscess (false-positive results) and borderline tumor (false-negative results). Pattern recognition correctly classified 86% (95% CI = 81.1% to 90.4%) of masses of these four histologic types as being benign or malignant, whereas a serum CA-125 at a cutoff of 30 U/mL correctly classified 41% (95% CI = 34.4% to 47.5%) of them. Pattern recognition assigned a correct specific histologic diagnosis to 333 (59%, 95% CI = 54.5% to 62.8%) of the 567 benign lesions.
Conclusion: Pattern recognition was superior to serum CA-125 for discrimination between benign and malignant adnexal masses.
| CONTEXT AND CAVEATS Prior knowledge Subjective evaluation of gray-scale and Doppler ultrasound findings (i.e., pattern recognition) by an experienced examiner and preoperative serum levels of CA-125 can both discriminate benign from malignant adnexal (i.e., ovarian, paraovarian, or tubal) masses. Study design Multicenter prospective study of 1066 women with a persistent adnexal mass that compared the abilities of pattern recognition and of CA-125 serum levels to classify masses as benign or malignant and to classify them further by histologic subtype. After its resection, each mass was examined histologically. Contribution Pattern recognition by an experienced examiner was superior to serum CA-125 for discrimination between benign and malignant adnexal masses and correctly classified more than half of the masses by subtype. Implications Measurement of CA-125 is not as helpful as pattern recognition by an experienced examiner for the correct classification of adnexal masses. Because the accuracy of pattern recognition depends on the level of experience of the examiner, more effort should be expended to educate and train ultrasound examiners. Limitations CA-125 serum levels were not available for 24% of patients, most of whom had benign masses by pattern recognition with a high degree of confidence. These results reveal a bias whereby serum CA-125 was more likely to be measured in women with masses that were suspected of being malignant.
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The funding agencies had no role in the design of the study, the collection of the data, the analysis and interpretation of the data, the writing of the manuscript or the decision to submit the manuscript for publication. The authors had full responsibility for all these activities.
Manuscript received May 22, 2007; revised September 4, 2007; accepted September 20, 2007.
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J Natl Cancer Inst 2007 99: 1653.
J Natl Cancer Inst 2007 99: 1653.
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