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Peptide

Lutetium-177 Dotatate (Lutathera)

Lutetium-177 dotatate is a radiolabeled somatostatin analog for peptide receptor radionuclide therapy (PRRT). FDA-approved 2018 for SSTR-positive GEP-NETs. NETTER-1 Phase 3: 65.2% PFS at 20 months vs 10.8% control. 79% reduction in disease progression/death risk. Median OS 48 months vs 36.3 months. First radiopharmaceutical for NETs.

Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.

Best evidence
Grade A
Conditions studied
1
Outcomes
10
Graded outcomes
4213

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

1 condition, plus general outcomes

Neuroendocrine Tumors: outcomes studied for Lutetium-177 Dotatate (Lutathera)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Progression-Free Survival

NETTER-1: 65.2% PFS rate at month 20 vs 10.8% control. 79% reduction in progression/death risk. Median PFS not reached vs ~8 months control. Doubled median PFS from 9 to 23 months in GEP-NETs.

Improves (the measure goes up)Large effect19 studies

Studies that measured progression-free survival

and 9 more in the citations list

Overall Survival

Final NETTER-1: Median OS 48.0 months vs 36.3 months control (11.7 month benefit). HR 0.84. Clinically meaningful survival advantage despite P=0.30 due to crossover.

Improves (the measure goes up)Large effect18 studies

Studies that measured overall survival

and 8 more in the citations list

Objective Response Rate

NETTER-1: Significantly higher ORR with 177Lu-DOTATATE vs control. 16% ORR including complete responses in ERASMUS study subset. Tumor shrinkage correlates with improved outcomes.

Improves (the measure goes up)Large effect17 studies

Studies that measured objective response rate

and 7 more in the citations list

Quality of Life

Time to QoL deterioration: 28.8 months vs 6.1 months (global health). Physical functioning: 25.2 months vs 11.5 months. Clinically significant improvements maintained long-term.

Improves (the measure goes up)Large effect17 studies

Studies that measured quality of life

and 7 more in the citations list

General

General: outcomes studied for Lutetium-177 Dotatate (Lutathera)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Anti-Cancer Activity

37 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect15 studies

Studies that measured anti-cancer activity

and 5 more in the citations list

Safety/Tolerability

9 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect14 studies

Studies that measured safety/tolerability

and 4 more in the citations list

GI Protection

4 human trials support this finding. Human clinical trial data available.

Improves (the measure goes up)Small effect9 studies

Studies that measured gi protection

Mortality

2 human trials support this finding. Human clinical trial data available.

Improves (the measure goes down)Small effect7 studies

Studies that measured mortality

Kidney Function

2 human trials support this finding. Human clinical trial data available.

Improves (the measure goes up)Small effect7 studies

Studies that measured kidney function

Liver Protection

2 human trials support this finding. Human clinical trial data available.

Improves (the measure goes up)Small effect7 studies

Key findings

  • Progression-Free SurvivalNeuroendocrine TumorsImproves (the measure goes up)
  • Overall SurvivalNeuroendocrine TumorsImproves (the measure goes up)
  • Objective Response RateNeuroendocrine TumorsImproves (the measure goes up)

Safety notes in the studies

  • 79% reduction in progression/death risk.

Studies cited

40 studies from PubMed

  1. Dosimetry of [177Lu]Lu-DOTATATE in Patients with Advanced Midgut Neuroendocrine Tumors: Results from a Substudy of the Phase III NETTER-1 TrialEur J Nucl Med Mol Imaging, 2025 · PMID 39947918
  2. Relationship Between Best Tumor Shrinkage and Progression-Free Survival and Overall Survival in Patients With Progressive Midgut Neuroendocrine Tumors Treated With [177Lu]Lu-DOTA-TATE: Ad Hoc Analysis of the Phase III NETTER-1 TrialOncologist, 2025 · PMID 40272146
  3. Evaluation of the Real-Life Efficacy and Safety of the Treatment with Lutetium-177 Dotatate for Metastatic Neuroendocrine Tumors.Journal of clinical medicine, 2025 · PMID 40217834
  4. Efficacy and Safety of Radioligand Therapy with Actinium-225 DOTATATE in Patients with Advanced, Metastatic or Inoperable Neuroendocrine Neoplasms: A Systematic Review and Meta-Analysis.Medicina (Kaunas, Lithuania), 2025 · PMID 40870386
  5. Evolving Immunotherapy Strategies in Gastrointestinal Neuroendocrine Neoplasms.Current treatment options in oncology, 2025 · PMID 39843688
  6. 177Lu-DOTATATE in Peptide Receptor Radionuclide Therapy: A Decade of Experience and EvolutionJ Nucl Med, 2024 · PMID 38117118
  7. Efficacy and Safety of Lu-177 DOTATATE Peptide Receptor Radionuclide Therapy in Patients with Unresectable or Metastatic Neuroendocrine Tumors in Korea.Targeted oncology, 2024 · PMID 38108953
  8. Comparison of the tolerability of (161)Tb- and (177)Lu-labeled somatostatin analogues in the preclinical setting.European journal of nuclear medicine and molecular imaging, 2024 · PMID 39046521
  9. Time toxicity of lutetium 177 in gastroenteropancreatic neuroendocrine tumours.Endocrine oncology (Bristol, England), 2024 · PMID 39649116
  10. 177Lu-labeled somatostatin receptor targeted radionuclide therapy dosimetry in meningioma: a systematic review.The quarterly journal of nuclear medicine and molecular imaging : official publication of the Italian Association of Nuclear Medicine (AIMN) [and] the International Association of Radiopharmacology (IAR), [and] Section of the Society of..., 2024 · PMID 39026463
  11. Pheochromocytoma: an updated scoping review from clinical presentation to management and treatment.Frontiers in endocrinology, 2024 · PMID 39735644
  12. Safety and Therapeutic Optimization of Lutetium-177 Based Radiopharmaceuticals.Pharmaceutics, 2023 · PMID 37111725
  13. Safety and Efficacy of 177 Lu-DOTATATE in Neuroendocrine Tumor Patients With Extensive Bone Disease.Clinical nuclear medicine, 2023 · PMID 37167406
  14. Survival and Response Outcomes for Gastrointestinal Neuroendocrine Tumor (GEP-NETs) Patients Treated with Lutetium-177-DOTATATE in a Brazilian Reference Center: A Six-Year Follow-Up Experience.Cancers, 2023 · PMID 37760475
  15. A Review of Theranostics: Perspectives on Emerging Approaches and Clinical Advancements.Radiology. Imaging cancer, 2023 · PMID 37477566
  16. An Analysis for Therapeutic Doses of Patients with Neuroendocrine Tumor Treated with Lutetium 177 ((177)Lu)-DOTATATE.Cancer biotherapy & radiopharmaceuticals, 2022 · PMID 34134512
  17. Lutetium-177 DOTATATE: A Practical Review.Practical radiation oncology, 2022 · PMID 35717045
  18. Comprehensive Assessment of Somatostatin Receptors in Various Neoplasms: A Systematic Review.Pharmaceutics, 2022 · PMID 35890290
  19. 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 trialLancet Oncol, 2021 · PMID 34793718
  20. NETTER-2 trial protocol: a prospective, international, open-label, randomized phase 3 study of 177Lu-DOTATATE compared with octreotide LAR in somatostatin receptor-positive, grade 2-3, midgut neuroendocrine tumorsBMC Cancer, 2021 · PMID 33947893
  21. Initial experience and lessons learned with implementing Lutetium-177-dotatate radiopharmaceutical therapy in a radiation oncology-based program.Brachytherapy, 2021 · PMID 32819853
  22. A clinical score for neuroendocrine tumor patients under consideration for Lu-177-DOTATATE therapy.Endocrine-related cancer, 2021 · PMID 33608484
  23. Symptom Diaries of Patients with Midgut Neuroendocrine Tumors Treated with (177)Lu-DOTATATE.Journal of nuclear medicine : official publication, Society of Nuclear Medicine, 2021 · PMID 33771903
  24. Cost-effectiveness of lutetium ((177)Lu) oxodotreotide vs everolimus in gastroenteropancreatic neuroendocrine tumors in Norway and Sweden.World journal of clinical cases, 2020 · PMID 33195647
  25. Intra-arterial versus standard intravenous administration of lutetium-177-DOTA-octreotate in patients with NET liver metastases: study protocol for a multicenter, randomized controlled trial (LUTIA trial).Trials, 2020 · PMID 32024533
  26. Additional holmium-166 radioembolisation after lutetium-177-dotatate in patients with neuroendocrine tumour liver metastases (HEPAR PLuS): a single-centre, single-arm, open-label, phase 2 study.The Lancet. Oncology, 2020 · PMID 32112737
  27. Lutathera®: The First FDA- and EMA-Approved Radiopharmaceutical for Peptide Receptor Radionuclide TherapyPharmaceuticals (Basel), 2019 · PMID 31362406
  28. 177Lu-DOTATATE for the treatment of gastroenteropancreatic neuroendocrine tumorsExpert Rev Gastroenterol Hepatol, 2019 · PMID 31652074
  29. Neuroendocrine Tumor Therapy with Lutetium-177: A Literature Review.Cureus, 2019 · PMID 30972265
  30. Therapy With (177)Lu-DOTATATE: Clinical Implementation and Impact on Care of Patients With Neuroendocrine Tumors.AJR. American journal of roentgenology, 2019 · PMID 31039017
  31. Protection of Kidney Function with Human Antioxidation Protein α(1)-Microglobulin in a Mouse (177)Lu-DOTATATE Radiation Therapy Model.Antioxidants & redox signaling, 2019 · PMID 29943622
  32. Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 TrialJ Clin Oncol, 2018 · PMID 29878866
  33. Gastroenteropancreatic Neuroendocrine Tumors.CA: a cancer journal for clinicians, 2018 · PMID 30295930
  34. The effect of kidney volume estimation on dosimetry in lutetium-177 DOTATATE therapy.Nuclear medicine communications, 2018 · PMID 29528911
  35. Everolimus, lutetium-177 DOTATATE and sunitinib for advanced, unresectable or metastatic neuroendocrine tumours with disease progression: a systematic review and cost-effectiveness analysis.Health technology assessment (Winchester, England), 2018 · PMID 30209002
  36. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine TumorsN Engl J Med, 2017 · PMID 28076709
  37. Long-Term Efficacy, Survival, and Safety of [(177)Lu-DOTA(0),Tyr(3)]octreotate in Patients with Gastroenteropancreatic and Bronchial Neuroendocrine Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research, 2017 · PMID 28428192
  38. Medical Therapy of Gastrointestinal Neuroendocrine Tumors.Visceral medicine, 2017 · PMID 29177164
  39. Early efficacy of and toxicity from lutetium-177-DOTATATE treatment in patients with progressive metastatic NET.Nuclear medicine communications, 2017 · PMID 28471845
  40. 177Lu-DOTATATE for the Treatment of Midgut Neuroendocrine Tumors: Long-term Results in 229 PatientsJ Nucl Med, 2008 · PMID 36068151