Next: Safety
5-HIAA, 5-hydroxyindoleacetic acid; CgA, chromogranin A; CrCL, creatinine clearance; CT, computed tomography; FDA, US Food and Drug Administration; GEP-NET, gastroenteropancreatic neuroendocrine tumor; HR, hazard ratio; IM, intramuscular; ITT, intent to treat; IV, intravenous; MRI, magnetic resonance imaging; NE, not evaluable; NR, not reached; PRRT, peptide receptor radionuclide therapy; RECIST, Response Evaluation Criteria in Solid Tumors; RLT, radioligand therapy; SSTR, somatostatin receptor; ULN, upper limit of normal.
References: 1. Lutathera [prescribing information]. Millburn, NJ: Advanced Accelerator Applications. 2. Strosberg J, El-Haddad G, Wolin E, et al; for the NETTER-1 trial investigators. Phase 3 trial of 177Lu-dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017;376(2):125-135. 3. Strosberg JR, Caplin ME, Kunz PL, et al; NETTER-1 investigators. 177Lu-dotatate plus long-acting octreotide versus high-dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2021;22(12):1752-1763. 4. US Food and Drug Administration. FDA approves new treatment for certain digestive tract cancers [press release]. January 26, 2018. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-certaindigestive-tract-cancers. Accessed February 24, 2021. 5. Hope TA, Bodei L, Chan JA, et al. NANETS/SNMMI consensus statement on patient selection and appropriate use of 177Lu-DOTATATE peptide receptor radionuclide therapy. J Nucl Med. 2020;61(2):222-227. 6. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247. 7. Strosberg J, Srirajaskanthan R, El-Haddad G, et al; NETTER-1 study group. Symptom diaries of patients with midgut neuroendocrine tumors treated with 177Lu-dotatate. J Nucl Med. 2021;62:1712-1718. 8. Strosberg J, Kunz PL, Hendifar A, et al; NETTER-1 study group. Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with 177Lu-dotatate: an analysis of the NETTER-1 study. Eur J Nucl Med Mol Imaging. 2020;47(10):2372-2382.