Improved management of ovarian malignancy 

    • Human epididymis protein 4 (HE4), is a serum biomarker which can be detected at high levels in patients with ovarian cancer.
    • A combination of multiple diagnostic modalities can improve the physician’s ability to preoperatively assess women with adnexal mass.
    • CA125 is widely used to predict malignancy in women with pelvic mass. However, it has limitations such as low sensitivity for early- stage ovarian cancers and a high rate of false positives among women with benign gynecological conditions, such as endometriosis.

    Early-stage diagnosis and specialized treatment can improve clinical outcomes in ovarian cancer

    • 20% of ovarian cancer patients do not express CA125 but do express HE4.1
    • If a cancer patient does not have elevated CA125, multiple CT scans will be required to follow treatment response and to detect recurrent disease.
    • HE4 can provide value to gynecologic oncologists when managing women diagnosed with ovarian cancer that do not express CA125 as a marker for their disease.

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  • HE4 in benign gynecological conditions

    • HE4 is not increased in patients with endometriomas and other types of endometriosis, as compared to CA125.2
    • HE4 is significantly higher in endometrial and ovarian cancers, but not in endometriosis.2
    • CA125 is elevated in ovarian cancer and endometriosis, but not in endometrial cancer.2
    • CA125 is the most commonly used biomarker for the diagnosis of ovarian cancer, but is associated with a high false positive rate among women with benign gynecological conditions.3
    • HE4 has consistently been observed to be less frequently elevated in benign conditions than CA125.2,3
    • In a study of 1,042 woman with pelvic mass HE4 was elevated in only 3% of premenopausal women with endometriosis, while CA125 was elevated in 72% of the same patient population.4
  • HE4 for ovarian cancer surveillance

    • HE4 was cleared by the FDA in 2008 as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer.
    • Measuring HE4 values during treatment may be a useful tool to monitor the response to therapy.
    • Increased levels of HE4 have been shown to precede CA125 by five to eight months, thus indicating to be an important early indicator of recurring disease.
    • HE4 can predict recurrence of ovarian cancer earlier than CA125 and can be elevated in patients that do not express CA125 at sufficient levels to make clinical decisions.


  • References

    1. Holcomb K , Vucetic Z, Miller MC, Knapp RC. Human epididymis protein 4 offers superior specificity in the differentiation of benign and malignant adnexal masses in premenopausal women. Am 1Obstet Gynecol. 2011; 205(4):358.el-6.
    2. Huhtinen K, Suvitie P, Hiisa J, et al. Serum HE4 concentration differentiates malignant ovarian tumours from ovarian endometriotic cysts. BR J Cancer. 2009;100:1315-1319.
    3. Moore RG, Miller MC ,Eklund EE, Lu KH, Bast RC Jr, Lambert-Messerlian G. Serum levels of the ovarian cancer biomarker HE4 are decreased in pregnancy and increase with age. Am J Obstet Gynecol. 2011; 206(4):349.el-7.
    4. Moore RG, Miller MC, Steinhoff MM, et al. Serum HE4 levels are less frequently elevated than CA125 in women with benign gynecologic disorders. Am J Obstet Gynecol. 2011;206(4):351.e1-8.
    5. Anastasi E, Marchei GG, Viggiani V, Gennarini G, Frati L, Reale MG. HE4: new potential early biomarker for the recurrence of ovarian cancer. Tumor Bioi 2010; 31:113-119.
    6. Schummer M, Drescher C, Forrest R, et al. Evaluation of ovarian cancer remission markers HE4, MMP7 and Mesothelin by comparison to the established marker CA125. Gynecol Oncol. 2011;125(1):65-9.