User:CalderoaLU/sandbox
Approval
[edit]· Lutathera, also known as lutetium Lu 177 dotatate, is a target treatment drug for patients suffering from GEP-NETs.[1] Its approval for Advanced Accelerator Applications was announced on January 26, 2018 by the US Food and Drug Administration.[2] Lutathera is most notable as the first FDA approved peptide receptor radionuclide therapy (PRRT) to combat GEP-NETs.[3]
GEP-NETs
[edit]· GEP-NETs are rare groups of cancer that continue to proliferate, regardless of initial therapy treatments.[1] They are present in areas affected by pancreatic or gastrointestinal cancers; specifically, the pancreas, stomach, intestines, colon and rectum.[2]
Use
[edit]· Lutathera is used to combat pancreatic and gastrointestinal cancers that do not respond well to common chemotherapeutical treatments; namely for patients with somatostatin receptor-positive GEP-NETs.[1][2] These receptors are commonly found on tumors located in the foregut, midgut, and hindgut.[4]
Mechanism
[edit]· Lutathera is a radioactive drug comprised of a tyrosine-containing somatostatin analog Tyr3-octreotate (TATE) attached to the chelating agent tetraazacyclododecanetetra-acetic acid (DOTA).[5] Attached to the dotatate is the radioactive marker Lu-177, a radioisotope.[1] The dotatate binds to the GEP-NET positive somatostatin receptor cells commonly present on neuroendocrine tumors.[1][5] After binding to the receptor, Lutathera enters the cell and uses its radioactive property to damage DNA.[1] This mechanism effectively triggers apoptosis of cancerous tumor cells. As a result, studies found that 16% of patients being treated with Lutathera experienced either complete or partial tumor shrinkage.[1]
Studies
[edit]· FDA approval of Lutathera was ultimately supported by two clinical studies.[2] NETTER-1, a Phase 3 study, was a randomized clinical trial which included patients with a severe form of somatostatin receptor-positive NETs.[1][3] The study compared Lutathera treatment with a standard dose of octreotided LAR against a high-dose of octreotide LAR.[1] Researchers measured tumor growth after the course of the treatment, also known as progression-free survival.[2] The study concluded that patients who were treated with Lutathera lived substantially longer compared to those who only received the octreotide treatment.[1] They experienced a 79% reduction in death and cancer progression.[3]
· The Netherlands study gathered several patients with somatostatin receptor-positive tumors, including patients with GEP-NETs.[1] The study found that 16% of patients with GEP-NETs, who were treated with Lutathera, experienced complete or partial tumor shrinkage.[1] As a result, a pre-planned interim overall survival analysis found that Lutathera treatment lead to a 48% reduction in risk of death.[3]
| Common problems | Symptoms/Reactions | Percent of patients affected |
| Nausea | 5% | |
| Vomiting | 7% | |
| Hyperglycemia | 4% | |
| Hypokalemia | 4% | |
| Liver problems | ||
| Increased Gamma-Glutamyl Transferase | 20% | |
| Elevated AST | 5% | |
| Increased ALT | 4% | |
| Tumor bleeding | ||
| Swelling (edema) | ||
| Tissue injury (necrosis) | ||
| Bone Marrow problems | ||
| Myelodysplastic syndrome | 2% | |
| Acute leukemia | 1% | |
| Kidney problems | ||
| Renal failure | 2% | |
| Neuroendocrine hormonal crisis | ||
| Hypotension | 1% | |
| Bronchospasm | ||
| Myelosuppression | 1% | |
| Lymphopenia | 44% | |
| Anemia | ||
| Thrombocytopenia | ||
| Leukopenia | ||
| Neutropenia | ||
| Cardiac problems | ||
| Myocardial infarction | 1% | |
| Cardiac failure | 2% | |
| Embryo-Fetal Toxicity | ||
| Causes harm to unborn fetuses | ||
| Temporary Infertility | ||
| May cause infertility |
Advances
[edit]· Lutathera is a major technological advancement for the detection of tumors. Diagnostic imaging that relies on dotatates can now rely on Lutathera to locate somatostatin receptor-positive tumors by tagging them with its radioactive component.[1] This tagging of tumors will allow them to become more visible during positron emission tomography (PET) scans.[1] With LU-177 dotatates, more somatostatin receptor-positive GEP-NET patients can be identified for treatment of the disease.[1]
- ^ a b c d e f g h i j k l m n o p "FDA Approves New Treatment for Neuroendocrine Tumors". National Cancer Institute. Retrieved 2018-05-26.
- ^ a b c d e f Commissioner, Office of the. "Press Announcements - FDA approves new treatment for certain digestive tract cancers". www.fda.gov. Retrieved 2018-05-26.
- ^ a b c d e "Advanced Accelerator Applications Receives FDA Approval for Lutathera® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors | Novartis". Novartis. Retrieved 2018-05-26.
- ^ a b "For Patients - Lutathera". Lutathera. Retrieved 2018-05-26.
- ^ a b "NCI Drug Dictionary". National Cancer Institute. Retrieved 2018-05-26.