- Adding a PET/CT scan with [18F]FES, a breast oncology PET
tracer, may increase the accuracy of knowing the estrogen receptor
(ER) status. This is notable when a tumor sample cannot be
obtained, or the risk of a biopsy-related complication is
high.
- Increased diagnostic accuracy may help clinicians select more
effective treatments and decrease the rate of re-biopsies,
resulting in the potential cost savings of $142M to the US
healthcare system over a five-year period,1 according to a new
study published in PLOS ONE.
- The study shows that adding a PET/CT scan with the [18F]FES
tracer, commercially available in the US as Cerianna, to
biopsy/immunohistochemistry (IHC) may increase the number of true
positive and true negative ER status test results by up to eight
percentage points2 compared to when biopsy/IHC is used alone.
GE HealthCare Pharmaco-Economic Study
Demonstrates Adding Breast Oncology PET Tracer to Standard Workup
of Patients with Metastatic or Recurrent Breast Cancer May Yield
Beneficial Clinical and Economic Outcomes, Potentially Saving $142M
Over Five Years in the US
In a GE HealthCare sponsored pharmaco-economic study published
in peer-reviewed journal PLOS ONE, the incidence, prevalence,
diagnostic pathways, and treatments of different patients with
metastatic or recurrent breast cancer were analyzed using a
combination of widely accepted statistical modelling methods to
estimate the clinical and associated economic impact of adding a
PET/CT scan with [18F]FES, a breast oncology PET tracer, to the
current standard diagnostic process.
Breast cancer is the most diagnosed cancer worldwide, with
approximately 2.3 million new cases appearing in 2020 alone.3
Correct identification of the receptor status in breast cancer is
crucial to optimize treatment; however, the diagnostic standard of
care which involves biopsy/IHC and imaging, can yield inconclusive
results. [18F]FES can be a powerful tool, providing high diagnostic
accuracy in detection of estrogen receptor (ER)-positive lesions.
The study demonstrated that adding a PET/CT scan with [18F]FES to
biopsy/IHC may increase the diagnostic accuracy of the ER status in
all appropriate patients with metastatic or recurrent breast
cancer. The clinical and economic benefits were especially
pronounced in those situations where a tumor sample cannot be
obtained, or the risk of a biopsy-related complication is high.
Regina Young, Head of Global Market Access in the Pharmaceutical
Diagnostics segment of GE HealthCare and lead author of the study
said, “We found that if [18F]FES PET/CT was added to the standard
diagnostic work up and in line with the Appropriate Use Criteria
(AUC) for ER-targeted PET Imaging,4 the increase in diagnostic
accuracy could improve the clinical outcomes. Additionally, results
suggested a positive correlation between increased diagnostic
accuracy, especially when multiple lesions are present,” said
Young. "The increase in true ER-positive and ER-negative results
may have beneficial clinical and economic outcomes primarily driven
by the avoidance of repeated biopsies and futile treatments.”
In 2023, FES PET imaging was added to the National Cancer Care
Network (NCCN) Clinical Practice Guidelines in Oncology for
ER-positive disease under certain circumstances during the systemic
staging workup of patients with metastatic and recurrent breast
cancer. This inclusion came after the Society of Nuclear Medicine
and Molecular Imaging (SNMMI) published its AUC to guide referring
and imaging physicians in appropriate use of ER-targeted PET
imaging with 16α-18F-fluoro-17ß Fluoroestradiol. According to
SNMMI, the inclusion of FES PET in its AUC is intended to help
healthcare practitioners provide patients with the best care in a
cost-effective manner. The AUC may also enable more efficient
approval of FES use by payers.5
GE HealthCare’s Cerianna is the only FDA-approved FES PET
imaging agent. Cerianna is indicated for use with PET imaging for
the detection of ER-positive lesions as an adjunct to biopsy in
patients with metastatic and recurrent breast cancer. Providing a
whole-body view of ER-positive lesions, Cerianna may deliver a
comprehensive assessment to assist in making an informed diagnosis
and individualized treatment plan for the patient.
GE HealthCare’s Pharmaceutical Diagnostics segment is a global
leader in imaging agents used to support around 119 million
procedures per year globally, equivalent to four patient procedures
every second. Its Molecular Imaging portfolio combines established
proprietary products across cardiology, neurology, and oncology,
with an innovative pipeline, all aimed at enabling better-informed
diagnosis and monitoring for improved therapy decision-making and
clinical outcomes.
About GE HealthCare Technologies Inc.
GE HealthCare is a leading global medical technology,
pharmaceutical diagnostics, and digital solutions innovator,
dedicated to providing integrated solutions, services, and data
analytics to make hospitals more efficient, clinicians more
effective, therapies more precise, and patients healthier and
happier. Serving patients and providers for more than 125 years, GE
HealthCare is advancing personalized, connected, and compassionate
care, while simplifying the patient’s journey across the care
pathway. Together our Imaging, Ultrasound, Patient Care Solutions,
and Pharmaceutical Diagnostics businesses help improve patient care
from diagnosis, to therapy, to monitoring. We are a $19.6 billion
business with approximately 51,000 colleagues working to create a
world where healthcare has no limits.
Follow us on LinkedIn, X (formerly Twitter), Facebook,
Instagram, and Insights for the latest news, or visit our website
https://www.gehealthcare.com/ for more information.
NCCN makes no warranties of any kind whatsoever regarding their
content, use or application and disclaims any responsibility for
their application or use in any way.
INDICATIONS AND USAGE:
CERIANNA is indicated for use with positron emission tomography
(PET) imaging for the detection of estrogen receptor (ER)-positive
lesions as an adjunct to biopsy in patients with recurrent or
metastatic breast cancer.
Limitations of
Use:
Tissue biopsy should be used to confirm
recurrence of breast cancer and to verify ER status by pathology.
CERIANNA is not useful for imaging other receptors, such as human
epidermal growth factor receptor 2 (HER2) and the progesterone
receptor (PR).
Important Safety Information
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Risk of Misdiagnosis
Inadequate Tumor Characterization and Other ER-Positive
Pathology
- Breast cancer may be heterogeneous within
patients and across time. CERIANNA images ER and is not useful for
imaging other receptors such as HER2 and PR. The uptake of
fluoroestradiol F 18 is not specific for breast cancer and may
occur in a variety of ER-positive tumors that arise outside of the
breast, including from the uterus and ovaries. Do not use CERIANNA
in lieu of biopsy when biopsy is indicated in patients with
recurrent or metastatic breast cancer.
False Negative CERIANNA
Scan
- A negative CERIANNA scan does not rule out
ER-positive breast cancer. Pathology or clinical characteristics
that suggest a patient may benefit from systemic hormone therapy
should take precedence over a discordant negative CERIANNA
scan.
Radiation Risks
- Diagnostic radiopharmaceuticals, including
CERIANNA, expose patients to radiation. Radiation exposure is
associated with a dose-dependent increased risk of cancer. Ensure
safe drug handling and patient preparation procedures (including
adequate hydration and voiding) to protect patients and health care
providers from unintentional radiation exposure.
Pregnancy Status
- Assessment of pregnancy status is
recommended in females of reproductive potential before
administering CERIANNA.
ADVERSE REACTIONS
- In Clinical Trials (n=1207) the most common
adverse reactions seen occurred at a rate < 1% were
injection-site pain and dysgeusia.
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
- All radiopharmaceuticals, including
CERIANNA, have the potential to cause fetal harm depending on the
fetal stage of development and the magnitude of radiation dose.
Advise a pregnant woman of the potential risks of fetal exposure to
radiation from administration of CERIANNA.
- There are no available data on CERIANNA use
in pregnant women. No animal reproduction studies using
fluoroestradiol F 18 have been conducted to evaluate its effect on
female reproduction and embryo-fetal development.
- The estimated background risk of major birth
defects and miscarriage for the indicated populations is unknown.
All pregnancies have a background risk of birth defects, loss, or
other adverse outcomes. In the U.S. general population, the
estimated background risk of major birth defects and miscarriage in
clinically recognized pregnancies is 2-4% and 15-20%,
respectively.
Lactation
Risk Summary
- There are no data on the presence of
fluoroestradiol F 18 in human milk, or its effects on the breastfed
infant or milk production. Lactation studies have not been
conducted in animals. Advise a lactating woman to avoid
breastfeeding for 4 hours after CERIANNA administration in order to
minimize radiation exposure to a breastfed infant.
Pediatric Use
- The safety and effectiveness of CERIANNA in
pediatric patients have not been established.
Geriatric Use
- Clinical studies of fluoroestradiol F 18
injection did not reveal any difference in pharmacokinetics or
biodistribution in patients aged 65 and over.
DRUG INTERACTIONS
Systemic Endocrine Therapies that Bind to
ER
- Drugs that bind to the ER, including SERMs
and SERDs, may compete with the binding of fluoroestradiol F18 and
may reduce detection of ER-positive lesions with CERIANNA.
- Before administration of CERIANNA,
discontinue drugs that bind to the ER, such as SERMs and SERDs, for
at least 5 biological half-lives: (e.g. elacestrant for 11 days,
tamoxifen for 8 weeks and fulvestrant for 28 weeks).
To report SUSPECTED ADVERSE REACTIONS,
contact GE HealthCare at 800 654 0118 (option 2 then option 1) or
by email at GPV.drugsafety@gehealthcare.com or FDA at
800 FDA 1088 or www.fda.gov/medwatch
1 Munter-Young R, Fuentes-Alburo A,
DiGregorio N, Neeser K, Gultyaev D (2024) Clinical and economic
outcomes of adding [18F]FES PET/CT in estrogen receptor status
identification in metastatic and recurrent breast cancer in the US.
PLoS ONE 19(5): e0302486.
https://doi.org/10.1371/journal.pone.0302486
2 Munter-Young, Fuentes-Alburo,
DiGregorio, Neeser, Gultyaev, 2024, Table 3
3 Sung H, Ferlay J, Siegel RL, Laversanne
M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020:
GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36
Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209–49. Epub
20210204. pmid:33538338.
4 Ulaner G, Mankoff D, Clark AS, Fowler
AM, Linden HM, Peterson LM, Dehdashti F, Kurland BF, Mortimer J,
Mouabbi J, Hyuk Moon D, de Vries EGE (2023) Summary: Appropriate
Use Criteria for Estrogen Receptor-Targeted PET Imaging with
16α-F-Fluoro-17β-Fluoroestradiol. The Journal of Nuclear Medicine
64 (3) 351-354.
https://doi.org/10.2967/jnumed.123.265420
5 Ulaner G, Mankoff D, Clark AS, Fowler
AM, Linden HM, Peterson LM, Dehdashti F, Kurland BF, Mortimer J,
Mouabbi J, Hyuk Moon D, de Vries EGE (2023) Summary: Appropriate
Use Criteria for Estrogen Receptor-Targeted PET Imaging with
16α-F-Fluoro-17β-Fluoroestradiol. The Journal of Nuclear Medicine
64 (3) 351-354.
https://doi.org/10.2967/jnumed.123.265420
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GE HealthCare Media Contact: Emmy Elguizaoui +1 (978)
243-7503 Emmy.Elguizaoui@gehealthcare.com
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