Cerianna PET scan in invasive lobular breast cancer

Comprising up to 15% of all cases, invasive lobular carcinoma is the second most common subtype of breast cancer. Invasive lobular carcinomas are known to have an atypical pattern of metastatic spread and diffuse growth, with fewer calcifications. Because of these characteristics, invasive lobular carcinomas are difficult to detect on imaging, including 18F-FDG PET/CT. Despite its increasing importance in breast cancer staging, 18F-FDG PET/CT underestimates invasive lobular carcinoma disease burden due to the low metabolic activity of these tumors.

To overcome this challenge, a focus on hormonal regulation is crucial as 95% of all invasive lobular carcinomas express estrogen receptors. The use of Cerianna may better assess the extent of disease in lobular breast cancer patients. A case series by Venema et al. presented the use of ¹⁸F-FES PET in three invasive lobular carcinoma cases (Venema et al., 2017). 18F-FES PET provided a significant contribution to clinical decision making when conventional imaging was equivocal and biopsy unattainable.

A recent retrospective analysis evaluated 18F-FDG and 18F-FES PET/CT in seven patients with invasive lobular carcinoma (Ulaner et al., 2020). Investigators showed that 18F-FES outperformed 18F-FDG in detecting metastatic lesions in these patients. 18F-FES PET/CT detected more metastatic lesions compared to 18F-FDG PET/CT in 5 of 7 patients, and SUVmax of 18F-FES avid lesions was also greater than SUVmax of 18F-FDG avid lesions.

Although limited by a small sample size, there appears to be a promising trend among multiple studies to demonstrate the improved value that Cerianna has over traditional imaging methods for staging of invasive lobular carcinoma. Due to the abundance of estrogen receptor expression in invasive lobular carcinoma, and the fact that metastatic disease is difficult to detect with conventional imaging, Cerianna may help assess the extent of disease in lobular breast cancer. These studies warrant larger prospective trials to investigate and establish definite clinical value of the additional sensitivity for metastatic disease with lobular histology.

References:

1. NCCN Guidelines Breast Cancer, Version
2. Hoefnagel LDC, van de Vijver MJ, van Slooten H-J, et al. Receptor conversion in distant breast cancer metastases. Breast Cancer Res BCR. 2010;12(5):R75. doi:10.1186/bcr2645
3. Amir E, Clemons M, Purdie CA, et al. Tissue confirmation of disease recurrence in breast cancer patients: pooled analysis of multi-centre, multi-disciplinary prospective studies. Cancer Treat Rev. 2012;38(6):708- 714. doi:10.1016/j.ctrv.2011.11.006
4. Nienhuis HH, van Kruchten M, Elias SG, et al. (18)F-Fluoroestradiol Tumor Uptake Is Heterogeneous and Influenced by Site of Metastasis in Breast Cancer Patients. J Nucl Med 2018; 59(8): 1212-8.
5. Linden HM, Stekhova SA, Link JM, et al. Quantitative Fluoroestradiol Positron Emission Tomography Imaging Predicts Response to Endocrine Treatment in Breast Cancer. J Clin Oncol. 2006;24(18):2793-2799. doi:10.1200/JCO.2005.04.3810
6. Boers J, Venema CM, de Vries EFJ, et al. Molecular imaging to identify patients with metastatic breast cancer who benefit from endocrine treatment combined with cyclin-dependent kinase inhibition. Eur J Cancer. 2020;126:11-20. doi:10.1016/j.ejca.2019.10.024
7. Sun Y, Yang Z, Zhang Y, et al. The Preliminary Study of 16α-[18F]fluoroestradiol PET/CT in Assisting the Individualized Treatment Decisions of Breast Cancer Patients. Gelovani JG, ed. PLOS ONE. 2015;10(1):e0116341. doi:10.1371/journal.pone.0116341
8. Venema, C., de Vries, E., Glaudemans, A., Poppema, B., Hospers, G., and Schroder, C. (2017). 18F-FES PET Has Added Value in Staging and Therapy Decision Making in Patients With Disseminated Lobular Breast Cancer. Clin Nucl Med 42, 612-614.
9. Ulaner GA, Jhaveri K, Chardarlapaty S, Hatzoglou V, Riedl C, Lewis JS, Mauguen A. Head-to-head evaluation of 18F-FES and 18F-FDG PET/CT in metastatic invasive lobular breast cancer. J Nucl Med. 2020 Jul 17:jnumed.120.247882. doi: 10.2967/jnumed.120.247882. Epub ahead of print. PMID: 32680923.

CERIANNA™ is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of ER (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.

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).

• Adverse Reactions – Reported adverse reactions include: injection site pain and dysgeusia
• Radiation Risks – Ensure safe drug handling and patient preparation procedures to protect patients and health care providers from unintentional radiation exposure.
• Risk of Misdiagnosis – Do not use CERIANNA™ in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer.
• Contraindications – None.
• Use in Specific Populations – Lactation: Interrupt breastfeeding. Advise a lactating woman to avoid breastfeeding for 4 hours after CERIANNA™ administration

To report SUSPECTED ADVERSE REACTIONS, contact Zionexa US Corp at +1.844.946.6392 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Recommended dose is 222 MBq (6 mCi), with a range of 111 MBq to 222 MBq (3 mCi to 6 mCi), administered as an intravenous injection over 1 to 2 minutes.
• Recommended imaging start time is 80 minutes (range 20 minutes to 80 minutes) after drug administration.
• See full prescribing information for additional preparation, administration, imaging, and radiation dosimetry information.

Injection: 148 MBq/mL to 3,700 MBq/mL (4 mCi/mL to 100 mCi/mL) of fluoroestradiol F 18 in a multiple-dose vial.

Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.

Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.

Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

Radiation Risk: Radiation-emitting products, including Fludeoxyglucose F 18 Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.

Blood Glucose Abnormalities: In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to ensure at least two days of normoglycemia prior to Fludeoxyglucose F 18 Injection administration.

Adverse Reactions: Hypersensitivity reactions with pruritus, edema, and rash have been reported. Have emergency resuscitation equipment and personnel immediately available.

Fludeoxyglucose F 18 Injection is manufactured and distributed by PETNET Solutions, Inc., 810 Innovation Drive, Knoxville, TN39732

You can find the full prescribing information here:

https://www.siemens-healthineers.com/molecular-imaging/petnet-solutions-mibr/fludeoxyglucose-f-18-injection