New biomarkers for ovarian cancer: OVA1 and ROMA in diagnosis

Key Points

The optimal management of a woman with an ovarian adnexal mass remains a clinical challenge to obstetricians, gynecologists, and other providers who care for women. Although after surgical evaluation many such masses ultimately are found to be benign, a woman with a malignant mass will need referral to a gynecologic oncologist for possible further surgical staging and determination for potential adjuvant therapy.

The clinical burden of ovarian cancer on patients, their families, and the US healthcare system cannot be underestimated. Unfortunately, less than half of all women with such malignancies are cared for by gynecologic oncologists, despite data supporting the improved outcome of women with ovarian cancer when they are evaluated and treated by a specialist in their care.^1-3

CA125: an imperfect tool

CA125 is not expressed by the surface epithelium of normal ovaries. Elevated CA125 levels in women with metastatic epithelial ovarian cancer, however, have led to the widespread adoption of this serum test as a potential marker of malignancy in women with a pelvic mass.

Unfortunately, the sensitivity and specificity of CA125 in predicting malignancy, along with the positive predictive value, remain low-approximately 50% of women with stage I epithelial ovarian cancers will have a normal CA125 level preoperatively. Further, several conditions, including malignancies of other abdominal organs and a number of benign conditions, will result in elevated levels.⁵

Developing novel biomarkers

There has been significant effort in the research and development of novel biomarkers applicable to the diagnosis and management of epithelial ovarian cancer. Several preliminary studies examining multiple novel biomarkers in addition to CA125 have led to initial enthusiasm.^6-8 These include the OvaSure serum test, which includes examination of leptin, prolactin, osteopontin, insulin-like growth factor-II, macrophage inhibitory factor, and CA125, as well as the OvaCheck test, which involves proteomic profile analysis of serum proteins. Unfortunately, the lack of validation studies has precluded their effectiveness as screening tests for ovarian cancer in otherwise asymptomatic women.

In contrast, new data examining additional biomarkers in women with a known pelvic mass have led to the development and validation of novel strategies that can be used in the clinical care of these patients.