NCCN Guidelines Endorse FES PET for Workup of Recurrent/Metastatic ER+ Breast Cancer

David Mankoff, MD, PhD

The National Comprehensive Cancer Network (NCCN) Guidelines now recommend the use of ¹⁸F-Fluorestradiol (¹⁸F-FES; Cerianna) positron emission tomography (PET) in certain circumstances during the systemic staging workup for patients with recurrent or metastatic for estrogen receptor (ER)–positive breast cancer.¹

This inclusion in the NCCN Guidelines comes after the publication of the October 2022 Appropriate Use Criteria, guiding referring and imaging physicians in the proper use of ER-targeted PET imaging with 16α-18F-fluoro-17ß Fluoroestradiol.² In the publication, the Society of Nuclear Medicine and Molecular Imaging ranked the appropriateness of using ¹⁸F-FES in clinical scenarios pertaining to diagnosis, staging, biopsy, and selection of therapy, and other:

Diagnosis

• Diagnosing primary breast cancer: Rarely appropriate
• Diagnosing malignancy of unknown primary when a biopsy is not feasible or is nondiagnostic: May be appropriate

Staging

• Routine staging of the primary tumor: Rarely appropriate
• Routine staging of axillary nodes: Rarely appropriate
• Routine staging of extra-axillary nodes and distant metastases: May be appropriate
• Staging invasive lobular carcinoma and low-grade invasive ductal carcinoma: May be appropriate

Biopsy

• Assessing ER status, in lieu of biopsy, in lesions that are easily accessible for biopsy: May be appropriate
• Assessing ER status in lesions that are difficult to biopsy, or when biopsy is nondiagnostic: Appropriate

Selection of Therapy

• After progression of metastatic disease, for considering second-line endocrine therapy: Appropriate
• At initial diagnosis of metastatic disease, for considering endocrine therapy: Appropriate
• At initial diagnosis of primary breast cancer, for considering endocrine therapy: Rarely appropriate

Other

• Measuring response to therapy: Rarely appropriate
• Detecting lesions in patients with suspected/known recurrent or metastatic breast cancer: May be appropriate
• Detecting ER status when other imaging tests are equivocal or suspicious: Appropriate

“The latest NCCN Guidelines reflect the impact the Cerianna PET is starting to have in the care of patients with metastatic breast cancer,” David Mankoff, MD, PhD, professor and vice chair of research in radiology at the University of Pennsylvania, stated in a news release.¹ “As was the case for fluorodeoxyglucose [FDG] PET, inclusion in the NCCN guidelines will help support access for Cerianna PET for patients with MBC and provides impetus for the medical community to define the clinical scenarios where Cerianna PET will be most helpful.”

In May 2020, the FDA approved the molecular imaging agent fluoroestradiol F 18 injection (Cerianna) for intravenous use in PET imaging for the detection of ER-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer, representing the first and only FDA-approved FES PET imaging agent.³

“FES PET, like FDG PET, is now included in the NCCN Guidelines. We have an opportunity to use FES PET to assess ER function in all tumor sites in patients with ER+ metastatic breast cancer,” Hannah M. Linden, MD, breast medical oncologist at the University of Washington and Fred Hutchinson Cancer Center in Seattle, Washington, said. “This is a helpful tool for diagnostic confirmation and may have the ability to aid in prognosis and prediction of clinical benefit from endocrine based therapies, including with CDK4/6 inhibitors. We have many endocrine options now, and FES PET may identify patients who remain ER+ and thus potentially benefit from endocrine based therapy.”

“We are delighted to see the inclusion of Cerianna PET in the NCCN breast oncology guidelines, for potential use when oncologists are evaluating metastatic breast cancer patients,” Mark Hibberd, MD, PhD, chief medical officer at GE HealthCare’s Pharmaceutical Diagnostics segment, said. “Detecting ER-positive lesions in patients with recurrent or metastatic breast cancer could potentially aid oncologists, surgeons and clinicians in choosing the most appropriate therapy for patients.”

References

1. GE HealthCare announces FES PET imaging recommendation in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). News release. GE HealthCare. May 24, 2023. Accessed May 25, 2023. https://www.gehealthcare.com/about/newsroom/press-releases/ge-healthcare-announces-fes-pet-imaging-recommendation-in-nccn-clinical-practice-guidelines-in-oncology-nccn-guidelines
2. Ulaner GA, Mankoff DA, Clark AS, et al. Appropriate Use Criteria for estrogen receptor-targeted PET imaging with 16α18F-Fluoro-17β-Fluoroestradiol. October 2022. Accessed May 25, 2023. https://s3.amazonaws.com/rdcms-snmmi/files/
3. PETNET Solutions and Zionexa USA announce FDA approval of Cerianna (fluoroestradiol F 18). News release. PETNET Solutions. May 27, 2020. Accessed May 25, 2023. https://www.siemens-healthineers.com/en-us/press-room/press-releases/ceriannafdaapproval.html