177Lu Dotatate (Lutathera) peptide receptor radionuclide therapy is approved by the FDA for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Specifically, it is indicated for:
- Unresectable or metastatic GEP-NETs
- Well differentiated (G1 and G2), somatostatin receptor positive tumors
Some key points about the FDA approval of 177Lu Dotatate:
- It was initially approved in January 2018 based on the results of the NETTER-1 phase 3 trial. This trial compared treatment with 177Lu Dotatate plus octreotide LAR versus high-dose octreotide LAR alone.
- The approval is for adult patients only at this time.
- Its use requires somatostatin receptor positivity confirmed by Ga-68 Dotatate PET/CT prior to initiation of therapy.
Mechanism of Action
- 177Lu Dotatate consists of the radioisotope Lutetium-177 (177Lu) bound to Dotatate, a somatostatin analog peptide.
- It binds to somatostatin receptors (SSTRs) which are overexpressed on neuroendocrine tumor cells.
- Upon binding, it internalizes into the tumor cells and the 177Lu decays delivering targeted radiation to tumor sites throughout the body.
=> This makes it an excellent
targeted radionuclide therapy option for metastatic GEP-NETs.
Efficacy
The approval of 177Lu Dotatate was based on the results of the
pivotal NETTER-1 phase 3 trial which demonstrated:
- Significantly improved progression-free survival (PFS) with 177Lu Dotatate plus octreotide LAR versus high-dose octreotide LAR alone
- PFS of 28.4 months vs 8.4 months, p<0.0001
- Objective response rate (ORR) of 18% with 177Lu Dotatate versus 3% with control octreotide LAR arm
These results supported an
FDA approval for 177Lu Dotatate about 5 years after NETTER-1 trial results were first published.
Safety
- The most common severe adverse reactions observed are: lymphopenia, increased GGT, vomiting, nausea, elevated AST, increased ALT, hyperglycemia and hypokalemia.
- Grade 3-4 myelosuppression can occur but usually resolves within 12 weeks.
- Long-term cumulative kidney and bone marrow toxicity can develop with repeated treatment cycles.
- Kidney and hematologic parameters should be monitored prior to each dose.
Overall, 177Lu Dotatate peptide receptor therapy Demonstrates a
reasonable safety profile that allows most patients to stay on treatment long term.
In summary, 177Lu Dotatate peptide receptor radionuclide therapy ushers in a new era of
precision nuclear medicine for the treatment of GEP-NETs. Its approval provides these patients with a
targeted, effective, and overall well-tolerated therapeutic option for managing
advanced, progressive tumors.
At Vitality Balance Clinic
Peptide Therapy Clinic](https://www.Vitality Balance Clinic.com), we provide access to 177Lu Dotatate for qualified candidates.
Contact us today to find out if you might benefit from this innovative new treatment option for neuroendocrine tumors.
