Phase 3 Trial of 177 Lu-Dotatate for Midgut Neuroendocrine Tumors
Open accessAbstract
BACKGROUND: Lu)-Dotatate in patients with advanced, progressive, somatostatin-receptor-positive midgut neuroendocrine tumors. METHODS: Lu-Dotatate group) or octreotide LAR alone (113 patients) administered intramuscularly at a dose of 60 mg every 4 weeks (control group). The primary end point was progression-free survival. Secondary end points included the objective response rate, overall survival, safety, and the side-effect profile. The final analysis of overall survival will be conducted in the future as specified in the protocol; a prespecified interim analysis of overall survival was conducted and is reported here. RESULTS: Lu-Dotatate group as compared with no patients in the control group, with no evidence of renal toxic effects during the observed time frame. CONCLUSIONS: Lu-Dotatate group. (Funded by Advanced Accelerator Applications; NETTER-1 ClinicalTrials.gov number, NCT01578239 ; EudraCT number 2011-005049-11 .).
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The positive results of the multicenter phase-III clinical trial NETTER-1, comparing [177Lu]Lu-DOTA-TATE to high doses of octreotide LAR, paved the way for Lutathera's approval by national and international medicines agencies in America and Europe.
“The positive results of the multicenter phase-III clinical trial [16], NETTER-1, comparing the treatment with [177Lu]Lu-DOTA-TATE to the treatment with high doses of octreotide LAR, paved the way for its approval by national and international medicines agencies in America and Europe.”
From Lutathera®: The First FDA- and EMA-Approved Radiopharmaceutical for Peptide Receptor Radionuclide Therapy (2019) · cites this paper as [16]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredWith adoption of amino acid pretreatment, the incidence of serious toxicity has been low, at or below 1.5% grade III or IV CTCAE, regardless of treatment schedule, number of cycles, and administered activity per cycle or cumulatively.
“In fact, with the adoption of amino acid pretreatment, the incidence of serious toxicity has been low, # 1.5% grade III or IV CTCAE, regardless of the treatment schedule, the number of cycles and administered activity per cycle or cumulatively ( 65 , 66 ).”
From Normal-Tissue Tolerance to Radiopharmaceutical Therapies, the Knowns and the Unknowns (2021) · cites this paper as [65]
The Methods (Trial Design; page unavailable) describe amino acid infusion for renal protection, and the Discussion reports low rates of grade 3 or 4 hematologic toxicity. But the Results (Treatment Administration and Safety; page unavailable) report grade 3 or 4 thrombocytopenia in 2% and lymphopenia in 9%, exceeding the claimed 1.5% ceiling. The trial used one planned treatment schedule and does not establish that toxicity was low regardless of schedule, cycle count, or activity. (LLM, conf=0.88)
Experimental — accuracy not yet measuredCompetitive inhibition of proximal tubular reabsorption by pretreatment with positively charged amino acids (arginine and lysine) has achieved a renal dose reduction of approximately 50%.
“of which competitive inhibition of proximal tubular reabsorption by pretreatment with positively charged amino acids (arginine and lysine) has achieved a renal dose reduction of approximately 50% and is widely adopted in clinical practice ( 64 , 65 ).”
From Normal-Tissue Tolerance to Radiopharmaceutical Therapies, the Knowns and the Unknowns (2021) · cites this paper as [65]
The Methods > Trial Design passage says the trial administered lysine and arginine for renal protection, beginning 30 minutes before the radiopharmaceutical infusion. Neither that passage nor the Discussion reports competitive inhibition of proximal tubular reabsorption or an approximately 50% reduction in renal radiation dose. The paper supports the use of the amino acids, but not the claimed mechanism or magnitude. (LLM, conf=0.88)
Experimental — accuracy not yet measuredConcurrent use of Luthera with octreotide led to significant improvement in progression-free survival and mortality risk reduction compared to octreotide alone.
“Concurrent use of this medication with octreotide led to significant improvement in progression-free survival and mortality risk reduction compared to octreotide alone [94].”
From Non-Diabetic Hypoglycemia: Evaluation and Management in Adults (2025) · cites this paper as [94]
The Methods (Trial Design) confirm that 177Lu-Dotatate was given with octreotide and compared with higher-dose octreotide alone. The Results (Efficacy) show significantly better progression-free survival and an estimated 60% lower risk of death, but the mortality finding came from an interim analysis that did not meet its prespecified significance threshold. The Discussion describes longer overall survival as a suggestion, not a confirmed benefit. (LLM, conf=0.88)
Experimental — accuracy not yet measured
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- Authors
- Strosberg, J., El-Haddad, G., Wolin, E., Hendifar, A., Yao, J., Chasen, B., Mittra, E., Kunz, P. L., Kulke, M. H., Jacene, H., Bushnell, D., O’Dorisio, T. M., Baum, R. P., Kulkarni, H. R., Caplin, M., Lebtahi, R., Hobday, T., Delpassand, E., Van Cutsem, E., Benson, A., Srirajaskanthan, R., Pavel, M., Mora, J., Berlin, J., Grande, E., Reed, N., Seregni, E., Öberg, K., Lopera Sierra, M., Santoro, P., Thevenet, T., Erion, J. L., Ruszniewski, P., Kwekkeboom, D., & Krenning, E.
- Affiliations
- University of Iowa (US)
- ORCID
- Strosberg, Jonathan
- El-Haddad, Ghassan
- Wolin, Edward
- Hendifar, Andrew
- Yao, James
- Mittra, Erik
- Kunz, Pamela L.
- Kulke, Matthew H.
- Jacene, Heather
- Bushnell, David
- O’Dorisio, Thomas M.
- Baum, Richard P.
- Kulkarni, Harshad R.
- Caplin, Martyn
- Lebtahi, Rachida
- Hobday, Timothy
- Benson, Al
- Srirajaskanthan, Rajaventhan
- Berlin, Jordan
- Grande, Enrique
- Reed, Nicholas
- Seregni, Ettore
- Erion, Jack L.
- Krenning, Eric
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-01-12
- Volume
- 376
- Issue
- 2
- Pages
- 125-135
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5895095
- OpenAlex
- W2573369749
- Cited by
- 3,308
- References
- 30
- Citations by year
- 2026: 374 · 2025: 369 · 2024: 390 · 2023: 350 · 2022: 364 · 2021: 427 · 2020: 355 · 2019: 277 · 2018: 254 · 2017: 145 · 2016: 1 · 2014: 1
- FWCI
- 220.74
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- RECERCAT (Consorci de Serveis Universitaris de Catalunya) (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
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- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion, other-oa)
- UKnowledge (University of Kentucky) (submittedVersion)
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- Research Portal (King's College London) (submittedVersion, other-oa)
- Funders
- Advanced Accelerator Applications
- National Institutes of Health (UL1TR000371)
- National Cancer Institute (P50CA174521, P30CA016672)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Epidemiology › Neuroendocrine Tumor Research Advances
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Pituitary Gland Disorders and Treatments
- Keywords
- 177Lu-DOTATATE, midgut neuroendocrine tumors, somatostatin receptor-positive tumors, octreotide LAR, radioligand therapy, progression-free survival, overall survival, nephrotoxicity, NETTER-1 trial
- MeSH terms
- Aged, Antineoplastic Agents, Delayed-Action Preparations, Drug Administration Schedule, Female, Gastrointestinal Neoplasms, Humans, Infusions, Intravenous, Male, Middle Aged, Nausea, Organometallic Compounds, Octreotide, Neuroendocrine Tumors, Disease-Free Survival, Kaplan-Meier Estimate
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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