NETs are malignancies recognized with increasing frequency
Neuroendocrine tumors (NETs) are malignancies that arise from neuroendocrine cells, which are specialized cells that secrete hormones and other bioactive substances and are found throughout the body. These cancers may or may not secrete bioactive substances at levels high enough to cause symptoms.1
Although classified as an orphan and rare disease, NETs are being diagnosed with increasing frequency.2 The reported incidence of NETs has increased >6-fold over the last 4 decades, according to SEER data from 1973-2012. The estimated incidence of NETs was 6.98/100,000 based on SEER data from 2012, while the estimated prevalence in 2012 was 48/100,000. The increase is thought to reflect improved awareness and diagnosis at earlier stages of the disease, though NETs are still often diagnosed at an advanced or metastatic stage.3
NETs are generally considered as indolent (slowly growing) tumors; however, the prognosis varies widely, according to2:
- Primary tumor site
- Tumor differentiation and grade
Although NETs can arise from a wide variety of organs and tissues, most NETs are gastroenteropancreatic (GEP-NETs), originating in the gastrointestinal (GI) tract and pancreas.2
Classification of GEP-NETs
GEP-NETs may be grouped according to the embryologic origin of the primary tumor site1:
- Foregut: gastric, duodenal, and pancreatic
- Midgut: jejunal, ileal, appendiceal, cecal, ascending, and right transverse colonic
- Hindgut: left transverse colonic to hindgut
Advanced GEP-NETs may be fatal, even for patients with
SEER, Surveillance, Epidemiology, and End Results.
References: 1. Alexandraki KI, Kaltsas G. Gastroenteropancreatic neuroendocrine tumors: new insights in the diagnosis and therapy. Endocrine. 2012;41(1):40-52. 2. Dasari A, Shen C, Halperin D, et al. Trends in the incidence, prevalence, and survival outcomes in patients with neuroendocrine tumors in the United States. JAMA Oncol. 2017;3(10):1335-1342. 3. Modlin IM, Oberg K, Chung DC, et al. Gastroenteropancreatic neuroendocrine tumors. Lancet Oncol. 2008;9(1):61-72.
IMPORTANT SAFETY INFORMATION1
WARNINGS AND PRECAUTIONS
The most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in LUTATHERA arm) observed in NETTER-1 were lymphopenia (44%), increased GGT (20%), vomiting (7%), nausea (5%), elevated AST (5%), increased ALT (4%), hyperglycemia (4%), and hypokalemia (4%).
In ERASMUS, the following serious adverse reactions have been observed with a median follow-up time of more than 4 years after treatment with LUTATHERA: myelodysplastic syndrome (2%), acute leukemia (1%), renal failure (2%), hypotension (1%), cardiac failure (2%), myocardial infarction (1%), and neuroendocrine hormonal crisis (1%). Patients should be counseled and monitored in accordance with the LUTATHERA Prescribing Information.
Somatostatin and its analogs competitively bind to somatostatin receptors and may interfere with the efficacy of LUTATHERA. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each LUTATHERA dose. Administer short- and long-acting octreotide during LUTATHERA treatment as recommended.
To report SUSPECTED ADVERSE REACTIONS, contact Advanced Accelerator Applications USA, Inc. at 1-844-863-19301-844-863-1930, or email@example.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
Distributed by: Advanced Accelerator Applications USA, Inc., NJ 07041
References: 1. LUTATHERA® [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; July 2018.