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177 Lu-DOTATATE for the treatment of gastroenteropancreatic neuroendocrine tumors
Open accessAbstract
Introduction: 177Lutetium-[DOTA°,Tyr3]octreotate (177Lu-DOTATATE) is a type of peptide receptor radionuclide therapy that garnered FDA approval in January 2018 for the treatment of somatostatin receptor-positive gastroenteropancreatic (GEP) neuroendocrine tumor (NET) patients. The therapy approval was based on findings from the randomized international phase III NETTER-1 trial as well as outcome data from a large European registry. The mechanism of the drug stems directly from its structure: a somatostatin analog (octreotate) selectively binding to somatostatin receptor expressing cells and being internalized, along with a chelated beta-emitting isotope 177Lu.Areas Covered: Herein we describe the pharmacology, clinical efficacy and adverse event data from prospective and retrospective studies with 177Lu-DOTATATE. We discuss the role of 177Lu-DOTATATE within the current treatment landscape for GEP NET patients.Expert Opinion: 177Lu-DOTATATE represents a unique addition to the treatment armamentarium for GEP NETs because of its potential to elicit tumor cytoreduction, which is rare among other existing treatment options, and prolonged disease control. Where 177Lu-DOTATATE fits into the treatment sequence for GEP NET patients remains an area of active investigation.
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“An excellent example is 177Lu-DOTATATE, a radiolabelled somatostatin analogue, used to treat neuroendocrine tumors (NETs) [91].”
From Radiopharmaceuticals: navigating the frontier of precision medicine and therapeutic innovation (2024) · cites this paper as [91]
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“Article highlights ● 177Lu-DOTATATE is a radiolabeled somatostatin agonist (SSA), which is approved for the treatment of somatostatin receptor positive welldifferentiated gastroenteropancreatic (GEP) neuroendocrine tumor (NET) patients in Europe, the United States, and Canada.”
BackgroundPhase 3 Trial of 177 Lu-Dotatate for Midgut Neuroendocrine Tumors
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“Nowadays, several FDA-approved theranostic pairs, such as [68Ga]DOTATATE and [177Lu]DOTATATE for neuroendocrine tumors, are used in clinical nuclear medicine practice [13,14].”
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“…approved for clinical use to treat somatostatin receptors and prostate-specific membrane antigen (PSMA) overexpressing cancers, respectively [22,23]. peptide–radionuclide conjugates, 177Lu-DOTA-TATE and 177Lu-PSMA-617, have been approved for clinical use to treat somatostatin receptors and fi c…”
Recent Advances in the Linkers of Drug Conjugates
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Advances and future directions in radiopharmaceutical delivery for cancer treatment
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177Lu-DOTATATE PRRT for Multiple Unusual Metastatic Sites in Neuroendocrine Tumor
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Side effects of theragnostic agents currently employed in clinical practice
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Navigating the landscape of theranostics in nuclear medicine: current practice and future prospects
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“The higher range and maximum energy of 90Y, despite its higher potential to cause AEs, can simultaneously bring a higher level of overall survival [6,32].”
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New Treatment Options for Pancreatic Neuroendocrine Tumors: A Narrative Review
Romanowicz, A., Fudalej, M. M., Asendrych, A., Badowska-Kozakiewicz, A. M., Nurzyński, P., & Deptała, A. (2025) · Cancers · doi:10.3390/cancers17233837 · Cited by 6
“…NETTER-1 study contributed to the Food and Drug Administration (FDA)’s approval in 2018 of 177Lu-DOTATATE for the treatment of advanced somatostatin receptor-positive NETs, including gastrointestinal and pancreatic tumors, despite the fact that the trial did not include patients with PanNETs [87].”
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“In another study, the peptide–drug conjugate DOTATATE, composed of the cyclic peptide H-D-Phe-Cys-Tyr-D-Trp-Lys-Thr-Cys-Thr-OH covalently linked to the chelator Tyr3-octreotate, has been successfully utilized to target gastro-entero-pancreatic neuroendocrine tumors [21].”
Cylindrical TGR as early radiological predictor of RLT progression in GEPNETs: a proof of concept
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Onkologische Theranostik in der Nuklearmedizin
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“Diese Ergebnisse führten 2018 zur Zulassung der Therapie [11, 12, 13].”
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“(177)Lu-dotatate is formed by coupling (177)Lu with the high-affinity somatostatin analog octreotate using the tetraxetan (DOTA) chelator molecule (15).”
An Overview of Structural Framework and Classification of Theranostic Radiopharmaceuticals
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“177 Lu-DOTATATE Lu-DOTATATE based peptide receptor RPT gained food and drug administration approval in 2018 for the treatment of neuroendocrine tumor patients [1].”
Radiation exposure and protection advice after [177Lu]Lu-DOTA-TATE therapy in China
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“Unlike conventional chemotherapy, radionuclide payloads deliver ionizing radiation directly to tumor cells through peptide-mediated receptor targeting, thereby maximizing tumor-localized cytotoxicity while sparing adjacent normal tissues [16,42].”
Dosing lutetium Lu 177‐dotatate for a hemodialysis patient
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Systemic Therapy for Pancreatic Neuroendocrine Tumors
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Self-citationCancer Theranostics: Pharmaceutical View
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Onkologische Theranostik in der Nuklearmedizin
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“Diese Ergebnisse führten 2018 zur Zulassung der Therapie [11, 12, 13].”
BackgroundA New Buffer for Gallium-68 Labeling Suitable for use in Nuclear Medicine; Triethanolamine (TEA)
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“[15,16] In this case, the tumor was surgically removed, and the lesion did not change significantly during the postoperative follow-up.”
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Metadata
- Authors
- Das, S., Al-Toubah, T., El-Haddad, G., & Strosberg, J.
- Affiliations
- Vanderbilt University Medical Center (US)
- Department of GI Oncology, Moffitt Cancer Center, Tampa, FL, USA
- Moffitt Cancer Center (US)
- Corresponding author
- Das, Satya
- Venue
- Expert Review of Gastroenterology & Hepatology
- Publisher
- Informa UK Limited
- Published
- 2019-10-30
- Volume
- 13
- Issue
- 11
- Pages
- 1023-1031
- ISSN
- 1747-4124 (ISSN-L)
- 1747-4132
- PMC
- PMC7227421
- OpenAlex
- W2981499856
- Cited by
- 135
- References
- 53
- Citations by year
- 2026: 23 · 2025: 32 · 2024: 32 · 2023: 15 · 2022: 20 · 2021: 9 · 2020: 4
- FWCI
- 6.28
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Expert Review of Gastroenterology & Hepatology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Cancer Institute (K12CA090625)
- Topics
- Health Sciences › Medicine › Oncology › Neuroendocrine Tumor Research Advances
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Peptidase Inhibition and Analysis
- Keywords
- 177Lu-DOTATATE, peptide receptor radionuclide therapy, gastroenteropancreatic neuroendocrine tumors, somatostatin receptors, octreotate, NETTER-1 trial, treatment efficacy, adverse events, treatment sequencing
- MeSH terms
- Animals, Gastrointestinal Neoplasms, Humans, Organometallic Compounds, Pancreatic Neoplasms, Octreotide, Treatment Outcome, Neuroendocrine Tumors, Radiopharmaceuticals
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