Tumor markers are blood tests that allow monitoring or tracking of response to treatment. For a tumor marker to be accepted for diagnostic purposes, a high standard of evidence must be met. In a recent retrospective review of markers in 256 patients , HE4 was the most effective of the 9 biomarkers (HE4, CA125, soluble mesothelin-related peptide (SMRP), CA72-4, activin A, inhibin, osteopontin, epidermal growth factor, and serum Her2). HA4 was better than CA125, which is currently the most widely used serum biomarker for detecting ovarian cancer and is the gold standard. Serum HE4 had the highest sensitivity (72.9%) for detecting a malignancy, at the specificity of 95%. When HE4 was combined with CA125, this increased further to yield a sensitivity of 76.4% and a specificity of 95%.
The combination of both biomarkers added 3.5% to the sensitivity of HE4 alone, and 33.1% to the sensitivity of CA125 alone. HE4 also had the highest sensitivity (45.9%, with a specificity of 95%) for detecting stage 1 disease and differentiating it from benign masses.
There are a number of studies that indicate that this marker may turn out to be useful. However, the currently available information is not sufficient to indicate widespread adoption and clinical use. I am not aware of guideline or consensus statements that recommend adoption and its clinical utility needs to be prospectively proven.
K Huhtinen et al, Serum HE4 concentration differentiates malignant ovarian tumors from ovarian endometriotic cysts 2009 Br J Cancer April 21; 100(8): 1315–1319.
Li J, Dowdy S, Tipton T, Podratz K, Lu WG, Xie X, Jiang SW. HE4 as a biomarker for ovarian and endometrial cancer management.Expert Rev Mol Diagn. 2009 Sep;9(6):555