Lutetium-177 Dotatate (Lutathera)

Peptide

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.

Quick Answer

What it is

Lutetium-177 dotatate is a radiolabeled somatostatin analog for peptide receptor radionuclide therapy (PRRT). FDA-approved 2018 for SSTR-positive GEP-NETs.

Key findings

  • Grade A: Progression-Free Survival (Neuroendocrine Tumors)
  • Grade A: Overall Survival (Neuroendocrine Tumors)
  • Grade A: Objective Response Rate (Neuroendocrine Tumors)

Safety

  • 79% reduction in disease progression/death risk.
  • 79% reduction in progression/death risk.
⚠️ Research Notice

This peptide information is for educational and research purposes only. Peptides may not be FDA-approved for human use and may only be legally available for research purposes. Consult qualified healthcare professionals before considering any peptide compounds.

ℹ️ Quick Facts: Lutetium-177 Dotatate (Lutathera)

Quick Facts: Lutetium-177 Dotatate (Lutathera)

  • Best Evidence:Grade A
  • Conditions Studied:1
  • Research Outcomes:10
  • Grade A Findings:4
  • Grade B Findings:2
  • Key Effect:Neuroendocrine Tumors
A4
B2
C1
D3
1 conditions · 10 outcomes

Detailed Outcomes

A
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.
large↑Improves
A
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.
large↑Improves
A
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.
large↑Improves
A
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.
large↑Improves
B
Anti-Cancer Activity
37 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
moderate↑Improves
B
Safety/Tolerability
9 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
moderate↑Improves
C
GI Protection
4 human trials support this finding. Human clinical trial data available.
small↑Improves
D
Mortality
2 human trials support this finding. Human clinical trial data available.
small↓Improves
D
Kidney Function
2 human trials support this finding. Human clinical trial data available.
small↑Improves
D
Liver Protection
2 human trials support this finding. Human clinical trial data available.
small↑Improves

Research Citations (40)

Dosimetry of [177Lu]Lu-DOTATATE in Patients with Advanced Midgut Neuroendocrine Tumors: Results from a Substudy of the Phase III NETTER-1 Trial
(2025)
PMID: 39947918
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 Trial
(2025)
PMID: 40272146
Evaluation of the Real-Life Efficacy and Safety of the Treatment with Lutetium-177 Dotatate for Metastatic Neuroendocrine Tumors.
(2025)
PMID: 40217834
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.
(2025)
PMID: 40870386
Evolving Immunotherapy Strategies in Gastrointestinal Neuroendocrine Neoplasms.
(2025)
PMID: 39843688
177Lu-DOTATATE in Peptide Receptor Radionuclide Therapy: A Decade of Experience and Evolution
(2024)
PMID: 38117118
Efficacy and Safety of Lu-177 DOTATATE Peptide Receptor Radionuclide Therapy in Patients with Unresectable or Metastatic Neuroendocrine Tumors in Korea.
(2024)
PMID: 38108953
Comparison of the tolerability of (161)Tb- and (177)Lu-labeled somatostatin analogues in the preclinical setting.
(2024)
PMID: 39046521
Time toxicity of lutetium 177 in gastroenteropancreatic neuroendocrine tumours.
(2024)
PMID: 39649116
177Lu-labeled somatostatin receptor targeted radionuclide therapy dosimetry in meningioma: a systematic review.
(2024)
PMID: 39026463

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