Biomarkers with Therapeutic or Prognostic Applications in Gynecologic Malignancies

The treatment of gynecologic malignancies has moved towards a precision medicine model with an approach to prognostication and management based on biomarker testing. The objective of this review is to describe the current landscape of biomarker testing in gynecologic cancer including clinical implications and the approach to testing.

A review of the literature was performed that included published clinical trials which utilized biomarker testing as part of inclusion/exclusion criteria, prospective trials that addressed the application and scoring of biomarkers utilized in gynecologic cancers, prospective clinical trials that utilized biomarker findings to determine management, and national or society guidelines for the scoring of biomarkers and treatment of gynecologic cancers.

The use of biomarker testing as part of the management of gynecologic cancers is the standard of care for both treatment and prognostication. In endometrial cancer, biomarker testing has been incorporated into the staging system and impacts treatment in both the upfront and recurrent setting. Specific biomarkers of interest for endometrial cancer include estrogen receptor (ER), progesterone receptor (PR), DNA Polymerase Epsilon (POLE), mismatch repair proteins (MMR), and Human Epidermal growth factor Receptor-2 (HER2). In ovarian cancer, biomarker testing is primarily utilized in the recurrent setting to guide management of platinum-resistant ovarian cancer with a specific focus on targeted therapy utilizing antibody drug conjugates (ADCs) and immunotherapy. Immunotherapy has become an important component of therapy for cervical cancer and Programmed death-ligand 1 (PD-L1) testing is a key biomarker in determining treatment.

The utilization of appropriate assays and processes to accurately assess the status of biomarkers in the pathology laboratory is crucial to the treatment of gynecologic malignancies in the precision medicine era.