OBJECTIVE: It is often difficult to distinguish a benign pelvic mass from a malignancy and tools to help referring physician are needed. The purpose of this study was to validate the Risk of Ovarian Malignancy Algorithm in women presenting with a pelvic mass.
METHODS: This was a prospective, multicenter, blinded clinical trial that included women who presented to a gynecologist, a family practitioner, an internist, or a general surgeon with an adnexal mass. Serum HE4 and CA 125 were determined preoperatively. A Risk of Ovarian Malignancy Algorithm score was calculated and classified patients into high-risk and low-risk groups for having a malignancy. The sensitivity, specificity, negative predictive value, and positive predictive value of the Risk of Ovarian Malignancy Algorithm were estimated.
RESULTS: A total of 472 patients were evaluated with 383 women diagnosed with benign disease and 89 women with a malignancy. The incidence of all cancers was 15% and 10% for ovarian cancer. In the postmenopausal group, a sensitivity of 92.3% and a specificity of 76.0% and for the premenopausal group the Risk of Ovarian Malignancy Algorithm had a sensitivity of 100% and specificity of 74.2% for detecting ovarian cancer. When considering all women together, the Risk of Ovarian Malignancy Algorithm had a sensitivity of 93.8%, a specificity of 74.9%, and a negative predictive value of 99.0%.
CONCLUSION: The use of the serum biomarkers HE4 and CA 125 with the Risk of Ovarian Malignancy Algorithm has a high sensitivity for the prediction of ovarian cancer in women with a pelvic mass. These findings support the use of the Risk of Ovarian Malignancy Algorithm as a tool for the triage of women with an adnexal mass to gynecologic oncologists.
LEVEL OF EVIDENCE: II
In women with a pelvic mass, the serum biomarkers HE4 and CA125 can accurately identify women at high risk for ovarian cancer.
From the Department of Obstetrics and Gynecology and the Center for Biomarkers and Emerging Technologies, Program in Women's Oncology, Women and Infants' Hospital, Brown University, Providence, Rhode Island; the Section of Gynecology Oncology, Department of Obstetrics and Gynecology, Oklahoma University Health Science Center, Oklahoma City, Oklahoma; Zimmer Cancer Center, New Hanover Regional Medical Center, Wilmington, North Carolina; Jackson Clinic, Jackson, Tennessee; and the Cancer Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Funded by Fujirebio Diagnostics Inc. Richard G. Moore is partially supported by National Cancer Institute (NCI) grant CA136491-01 and Steven J. Skates is partially supported by NCI grant CA152990.
Corresponding author: Richard G. Moore, MD, Program in Women's Oncology, Women and Infants' Hospital, Brown University, Providence, RI 02925; e-mail: firstname.lastname@example.org.
Financial Disclosure Dr. Moore receives research funding from Fujirebio Diagnostics Inc and Abbott Diagnostics Inc. M. Craig Miller receives consulting fees from Fujirebio Diagnostics Inc. Dr. Ball received research funding from Fujirebio Diagnostics Inc. The other authors did not report any potential conflicts of interest.