A recent study published in the journal PLOS ONE has revealed that incorporating a PET/CT scan with [18F]FES, a breast oncology PET tracer known commercially in the US as Cerianna, may enhance the accuracy of determining the
estrogen receptor (ER) status in
breast cancer patients. This method is particularly beneficial in situations where obtaining a
tumor sample is not feasible or when there is a heightened risk of biopsy-related complications. Enhanced diagnostic accuracy can potentially lead to more effective treatments and reduce the need for re-biopsies, resulting in cost savings of approximately $142 million for the US healthcare system over a five-year period.
This
GE HealthCare-sponsored pharmaco-economic study analyzed the incidence, prevalence, diagnostic pathways, and treatment strategies for patients with
metastatic or recurrent breast cancer. Using widely accepted statistical modeling, the study assessed the clinical and economic impacts of adding a PET/CT scan with [18F]FES to the existing diagnostic process. Breast cancer remains the most diagnosed cancer globally, with about 2.3 million new cases in 2020, making accurate receptor status identification crucial for optimal treatment.
The standard diagnostic care, which includes biopsy and immunohistochemistry (IHC), sometimes yields inconclusive results. The [18F]FES tracer has shown high diagnostic accuracy in detecting
ER-positive lesions. According to the study, adding this PET/CT scan to the standard biopsy/IHC process may increase the accuracy of ER status tests by up to eight percentage points. Such improvements are especially significant when a tumor sample cannot be obtained or when there is a high risk of complications from a biopsy.
Regina Young, the Head of Global Market Access in the Pharmaceutical Diagnostics segment of GE HealthCare and the lead author of the study, stated that incorporating [18F]FES PET/CT into the standard diagnostic workflow, in alignment with the Appropriate Use Criteria (AUC) for ER-targeted PET imaging, could enhance clinical outcomes. The study indicated a positive correlation between increased diagnostic accuracy and the presence of multiple lesions. This improvement in true ER-positive and ER-negative results can lead to better clinical and economic outcomes by avoiding repeated biopsies and unnecessary treatments.
In 2023, FES PET imaging was included in the National Cancer Care Network (NCCN) Clinical Practice Guidelines for Oncology for ER-positive disease, under specific circumstances during the systemic staging workup of patients with metastatic and recurrent breast cancer. This inclusion followed the Society of Nuclear Medicine and Molecular Imaging (SNMMI) publishing its AUC to guide appropriate use of ER-targeted PET imaging. The AUC aims to help healthcare providers offer cost-effective patient care and facilitate approval of
FES use by payers.
Cerianna, the only FDA-approved FES PET imaging agent, is indicated for use with PET imaging to detect ER-positive lesions as an adjunct to biopsy in patients with metastatic and recurrent breast cancer. It provides a comprehensive assessment of ER-positive lesions throughout the body, aiding in informed diagnosis and personalized treatment planning.
GE HealthCare’s Pharmaceutical Diagnostics segment, a global leader in imaging agents, supports around 119 million procedures annually worldwide. Its Molecular Imaging portfolio includes established products across cardiology, neurology, and oncology, aiming to enable better-informed diagnosis and monitoring for improved therapy decisions and clinical outcomes.
GE HealthCare is a prominent global medical technology, pharmaceutical diagnostics, and digital solutions provider, dedicated to offering integrated solutions, services, and data analytics to enhance hospital efficiency, clinician effectiveness, therapy precision, and patient health. With over 125 years of service, GE HealthCare focuses on advancing personalized, connected, and compassionate care, simplifying the patient journey across the care pathway.
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